Code of Colorado Regulations
1100 - Department of Labor and Employment
1101 - Division of Labor Standards and Statistics (Includes 1103 Series)
7 CCR 1101-3 R17 Ex 01 - Rule 17, Exhibit 1 - LOW BACK PAIN MEDICAL TREATMENT GUIDELINES
Section 7 CCR 1101-3-17-01-7 - Second Line Treatment

Universal Citation: 1100 CO Code Regs 7 CCR 1101-3-17-01-7

Current through Register Vol. 47, No. 5, March 10, 2024

Section 7.a. Core Second Line Treatment

Section 7.a.i. Active Therapies

Introduction. Active therapies are therapeutic exercises and/or activities that intend to restore flexibility, strength, endurance, function, and range of motion (ROM) and to alleviate discomfort. They require intrinsic motivation by the patient to complete a specific exercise or task. The following active therapies are common treatments:

* activities of daily living (ADLs) therapy,

* aquatic therapy,

* back schools,

* functional activities therapy,

* functional electrical stimulation or neuromuscular electrical stimulation (NMES),

* neuromuscular re-education,

* Pilates,

* tai chi,

* therapeutic exercise,

* yoga,

* work conditioning, and

* work simulation.

Active therapies also include developing functional goal-setting, maintaining or returning to usual activities and exercise in a graded fashion, and providing patient education and key recovery messages. Active therapies may coincide with pain neuroscience education. Pain neuroscience education involves educating patients about the biological and physiological processes involved in their pain experience and, importantly, deemphasizing the issues associated with anatomical structures, pain generators, and tissue damage.

Individual patients may benefit from additional education approaches. Education may include, but is not limited to: a favorable prognosis for recovery, the importance of continuing daily activities, promotion of self-efficacy, problem-solving, engagement of support systems, and relaxation techniques.

Contraindications / Side Effects and Adverse Events.

Relative Contraindications to Active Therapies.

* Motor, sensory, or reflex abnormalities are relative contraindications to the use of the McKenzie Method of Mechanical Diagnosis and Therapy.

* Pulmonary or cardiac conditions limiting participation are relative contraindications to active therapy.

Side Effects and Adverse Events Related to Active Therapies.

* Exercise therapy may result in temporary thoracic or lumbar muscle soreness. This side effect, within reasonable limits, should not deter continued active therapy.

Recommendations.

Core Requirements.

Recommendation 47. Active interventions, including therapeutic exercise and/or functional treatment, are recommended in the treatment of low back pain (table 13).

Recommendation 48. Medical clearance is required prior to participation in active therapies if a patient has any of the following:

* angina/dyspnea on exertion or at rest,

* paroxysmal nocturnal dyspnea and/or orthopnea,

* syncope or presyncope,

* arrhythmia or palpitations, or

* cardiac murmur (see Contraindications to Active Therapies).

Recommendation 49. Patients in active therapy must:

* demonstrate functional progress that is documented through validated sequential functional assessment measures,

* return to work with decreased restrictions, and/or

* have improvement in clinical measures (e.g., strength, ROM, and ADLs).

If there is no documented evidence of functional progress after 6 treatments, the therapy will be discontinued and the patient must be referred back to their treating provider for further evaluation. Each patient is limited to a maximum of 4 discrete active therapy trials without documented functional progress (Appendix Functional Screens).

Recommendation 50. A patient is allowed up to 6 active therapy visits to advance their active home exercise program. These visits are contingent on documented demonstration of previously instructed exercises, performance of their home program at the recommended frequency, and progress in their exercise program.

Recommendation 51. Adjunct passive therapy can occur concurrently with active therapy and the frequency of passive therapies will decrease over time. See the Passive Therapies section.

* Recommendation 52. Durations of care beyond those listed as "time to produce effect" and "maximum" are warranted in certain circumstances when treatment to date has resulted in measurable and clinically meaningful functional improvement. These circumstances include:

* re-injury;

* interrupted continuity of care;

* after surgery, particularly after multiple surgeries;

* injuries (e.g., fracture); or

* comorbidities.

Recommendation 53. Functional electrical stimulation or NMES home units require prior authorization, documenting medical justification for home use.

Time Frames.

Time Frames for Active Therapies

Time to produce effect

Frequency

Optimum duration

Maximum duration

6 treatments

up to 4 times per week

6 weeks

8 weeks

Evidence Tables.

Table 11.

Evidence Table: Therapeutic Response Considerations in Low Back Pain

Some evidence

Evidence statement

Design

Stratification of patients with low back pain using the STarT Back questionnaire can identify patients at low risk of poor outcomes and prevent unnecessary referrals for physical therapy which adds little incremental benefit over minimal care. Patients at medium and high risk may also benefit from receiving appropriate referrals for physical therapy.

RCT

Table 12.

Evidence Table: Timing of Physical Therapy Initiation and Low Back Pain

Some evidence

Evidence statement

Design

In patients with subacute low back pain and symptoms distal to the knee, early physical therapy produces improvements in function and pain similar to those seen with a single education session and follow-up with a primary care physician. A modified version of the ODI was used in this study.

RCT

In patients with subacute low back pain and symptoms distal to the knee, early physical therapy does not reduce the utilization of advanced imaging, spinal injection, emergency department visits, or spine surgery in the year following initial consultation. A modified version of the ODI was used in this study.

RCT

Table 13.

Evidence Summary: Active Therapies

Active therapies may provide modest functional benefit and symptomatic relief in patients with subacute and chronic low back pain. No evidence demonstrates that 1 form of active therapy is superior to any other, and the selection of an active therapy may be guided by local availability and the patient's preference and capability. While the evidence does not support the use of active therapies in acute low back pain, they are generally accepted interventions for patients at risk for immobility or deconditioning. Patients with barriers to functional recovery may benefit from the incorporation of pain education into therapeutic exercise.

Table 14.

Evidence Table: Exercise and Low Back Pain

Summary:

For patients with subacute and chronic low back pain, exercise-based interventions may reduce pain and disability.

Good evidence

Evidence statement

Design

For acute or subacute low back pain, no difference was found between exercise therapy and no exercise on pain.

Systematic review

Exercise alone or as part of a multi-disciplinary program results in decreased disability for workers with non-acute low back pain.

Systematic review

A web-based 11 minute postural and exercise program that can be used daily by sedentary workers with nonspecific low back pain who work at a computer is likely to lead to clinically important improvements in back pain disability and in the endurance of abdominal and lumbar muscles, while reducing the risk of new episodes of back pain.

RCT

Good evidence cont.

Massage therapy in combination with exercise reduces pain and improves function short-term for patients with subacute low back pain.

Systematic review

Some evidence

Evidence statement

Design

In patients with acute low back pain lasting less than 15 days and with a modified Oswestry Disability Index (ODI) score of 20 or higher and no symptoms distal to the knee, early intervention with physical therapy consisting of manipulation and exercise produces improvements similar to those seen with providing an instructional booklet and follow-up with a primary care physician.

RCT

In patients with acute low back pain lasting less than 15 days and with a modified ODI score of 20 or higher and no symptoms distal to the knee, early physical therapy does not appreciably reduce the utilization of advanced imaging, spinal injection, emergency department visits, and spine surgery in the year following the onset of acute low back pain.

RCT

An unsupervised, 12-week, periodized musculoskeletal rehabilitation program of weight training conducted 2, 3, or 4 days a week is effective at improving musculoskeletal strength and quality of life and at reducing pain and disability in untrained persons with chronic low back pain. The 4 days a week training volume is most effective. The volume (total number of reps) of periodized musculoskeletal rehabilitation exercise prescribed is important.

RCT

Trunk balance exercises combined with flexibility exercises are more effective than a combination of strength and flexibility exercises in reducing disability and improving physical function in patients with chronic low back pain.

RCT

There is no significant difference in the effectiveness of an 8-week supervised walking program, an evidence-based group exercise class, and usual physiotherapy for improvement in functional disability after 6 months for people

RCT

with chronic low back pain; all 3 interventions resulted in small, significant improvements in physical function, reduction of pain, quality of life, and fear avoidance over time.

In those who have chronic low back pain, 12 weeks of supervised high-dose exercise, spinal manipulative therapy, or low-dose home exercise with advice are all equally effective for reducing pain in the short- and long-term (1 year).

RCT

There is a modest benefit from adding a back school to other treatments such as non-steroidal anti-inflammatory drugs (NSAIDs), massage, transcutaneous electrical nerve stimulation (TENS), and other physical therapy modalities.

Systematic review

Disability improved in patients with lumbar spinal stenosis who underwent 6 or 12 sessions (3 and 6 weeks respectively) of cycling as measured by the Roland Morris Questionnaire.

RCT

Some evidence cont.

Aquatic exercises can be encouraged as part of an exercise program for patients with low back pain. Aquatic exercise could increase physical function in patients with low back pain.

However, there is no evidence that aquatic exercise is superior to other forms of active physical therapy. The participation of the patient is likely to influence the outcome of the exercise program, and it is reasonable to offer aquatic exercise to patients who have a distinct preference for it over other forms of exercise.

Systematic review

Table 15.

Evidence Table: Motor Control Exercise and Low Back Pain

Summary:

Motor control exercises are more effective than no exercise in reducing pain and improving disability in patients with chronic low back pain.

Strong evidence

Evidence statement

Design

In the short, intermediate, and long-term, motor control exercises that emphasize the transversus abdominis and multifidus are at least as effective as other forms of exercise and manual therapy. They are possibly more effective than other minimal interventions in reducing pain and improving disability in patients for the treatment of chronic non-specific low back pain.

Systematic review

Good evidence

Evidence statement

Design

For chronic low back pain, exercise and motor control exercise were associated with greater pain relief than no exercise.

Systematic review

Some evidence

Evidence statement

Design

Among patients with recurrent non-specific low bacl< pain and associated motor control impairment of at least 6 weeks duration, an intervention consisting of 5 sessions of specific movement control exercise and manual therapy may be as effective as a general exercise regimen and manual therapy in reducing disability at 12 months.

RCT

Table 16.

Evidence Table: The McKenzie Method and Low Back Pain

Summary:

For patients with subacute back pain, the McKenzie method results in similar disability reduction as compared to chiropractic manipulation.

Good evidence

Evidence statement

Design

Centralization is a favorable prognostic factor in low back pain with and without sciatica.

Systematic review

A 12-week course of McKenzie therapy is at least as effective as, and may have modestly superior results to, chiropractic manipulation in reducing disability from nonspecific low back pain lasting 6 weeks or more.

RCT

Some evidence

Evidence statement

Design

Referral of patients for chiropractic care or McKenzie physical therapy in the first weeks of uncomplicated low back pain adds little to the otherwise favorable prognosis for acute low back pain and does incur additional short-term costs of care.

RCT

The McKenzie approach provides similar outcomes in improving pain, disability, and ability to carry out work activities in comparison with cognitive behavioral therapy (CBT).

RCT

The McKenzie method is as effective as intensive dynamic strengthening training in reducing short-term back and leg pain intensity in nonspecific low back pain.

RCT

Table 17.

Evidence Table: Yoga and Low Back Pain

Summary:

Yoga results in improved pain and disability for patients with low back pain as compared to education alone or usual care.

Strong evidence

Evidence statement

Design

Yoga has small to moderate advantages over providing only a booklet in reducing low back pain and back-specific disability, but there is no evidence

Systematic review

that yoga is superior to stretching and strengthening classes led by a licensed physical therapist.

Good evidence

Evidence statement

Design

In the setting of chronic low back pain, an 8-week mindfulness-based stress reduction meditation program with yoga or 8 weeks of CBT resulted in small, significant improvements in physical function and reduction in pain compared to usual care at 26 weeks with no significant differences in outcomes between the 2 treatments.

RCT

Good evidence cont.

Compared with education, yoga was associated with lower pain intensity and better function at short-term for chronic low back pain.

Systematic review

Yoga is comparable to or of small additional benefit when added to usual care for chronic low back pain.

Systematic review

Some evidence

Evidence statement

Design

Iyengar yoga, which avoids back bending, results in improved function and decreased chronic mechanical low back pain for up to 6 months. Instruction occurred 2 times per week for 24 weeks and was coupled with home exercise. One quarter of the participants dropped out.

RCT

Yoga emphasizing mobility, strength, and posture to relieve pain may be more effective than usual care for chronic and recurrent low back pain.

RCT

Table 18.

Evidence Table: Pilates and Tai Chi in Low Back Pain

Summary:

Pilates is as effective as other forms of exercise in improving disability for patients with chronic low back pain. Tai chi may reduce pain and improve function for patients with chronic low back pain.

Good evidence

Evidence statement

Design

Pilates exercise shows statistically and clinically significant reductions in pain and statistically significant improvements in function in the short-term (maximum follow-up 15 weeks) compared with usual care, no exercise, education, or physical activity for the treatment of patients with chronic low back pain.

Systematic review

Pilates is more effective in reducing pain and improving disability compared with a minimal intervention at intermediate term follow-up, but pilates is equally as effective as other forms of exercise in improving disability at short- or intermediate-term follow-up for the treatment of patients with chronic nonspecific low back pain.

Systematic review

Some evidence

Evidence statement

Design

Tai chi had a small effect on reducing pain and improving function in chronic low back pain as compared to wait-list or no tai chi.

Systematic review

Table 19.

Evidence Table: Active Therapies with Education for Back Pain

Summary:

Active therapies with education lead to greater improvements in function, pain, and return to activity, compared to active therapy alone. The professional delivering such interventions should have training to do so.

Good evidence

Evidence statement

Design

Patients with at least 6 weeks of non-specific low back pain can achieve sustained reductions in pain and disability over a 12-month period after participating in physiotherapist-led cognitive behavioral interventions. Physiotherapist-led cognitive behavioral interventions included in this review focused on a selection of cognitive behavioral techniques designed to reduce the fear of movement and pain-related disability such as pacing, goal setting, problem-solving, relaxation, and challenging unhelpful thoughts relevant to low back pain.

Furthermore, the physiotherapist in the study received 16 to 72 hours of additional training. However, the details of the training program are not well-known, potentially limiting the reproducibility of study findings.

Systematic review

Some evidence

Evidence statement

Design

Among patients with non-radicular, nonspecific and uncomplicated low back pain (<8 weeks duration), disability observed at 4 weeks and 6 months post-treatment are dependent on an interaction between the type of treatment received and the baseline level of fear-avoidance beliefs. That is, the effectiveness of fear-avoidance-based physical therapy depends on the level of the individual patient's fear-avoidance beliefs regarding back pain. Patients who avoid physical activity because they fear exacerbating their pain are more likely to benefit from physical therapy if that physical therapy includes elements of the accentuated physical therapy described in this study: a graded exercise program that places special emphasis on seeing back pain as a common condition with a favorable prognosis and encourages the patient to play an active role in recovery from the current back pain episode. Patients who do not limit their activities because of these beliefs are probably better served by a standard physical therapy program.

RCT

A 2-day course focusing on the biopsychosocial model with an emphasis on the goals of returning to usual activities and fitness is as effective in reducing disability as 6 sessions of manual therapy sessions provided by physiotherapists and more limited patient education.

RCT

A cognitive intervention consisting of 2 consultations lasting 1 hour each with a physical medicine specialist and a physical therapist covering coping strategies and patient education on motion produces short-term reductions in sub-acute back disability.

RCT

Some evidence cont.

12 sessions of either graded activity or physiotherapy exercises over 6 weeks were similarly effective in reducing short-term pain and disability, improving quality of life, global perceived effect, return to work, physical activity, physical capacity, and kinesiophobia in patients with chronic nonspecific low back pain.

RCT

Intensive exercise for approximately 25 hours per week for 4 weeks, combined with cognitive interventions emphasizing the benefits of maintaining usual activity, produces functional results similar to those of posterolateral fusion in patients with chronic non-radicular back pain and no stenosis or instability after 1 year.

RCT

Among patients with chronic nonspecific low back pain, a 12-week physiotherapist-led cognitive-based program emphasizing specific movement exercises, targeted functional integration activities into daily life, and physical activities suited to the patient's preference was found to be more effective than a combination of manual therapy and exercise in improving disability and pain for up to 12 months.

Physiotherapists underwent an extensive training program prior to delivering the intervention, averaging 106 hours that consisted of workshops, patient examinations, pilot study, and clinical manuals.

RCT

An integrated care program, consisting of workplace interventions and graded activity teaching that pain need not limit activity, is effective in returning patients with chronic low back pain to work, even with minimal reported reduction of pain.

RCT

Incorporating telephone-delivered cognitive-behavioral strategies into postoperative physical therapy for patients at-risk for poor outcomes after lumbar laminectomy with or without fusion for degenerative conditions produced significant and clinically meaningful improvements in pain, disability, general health, psychosocial risk factors, and physical performance outcomes compared with telephone-delivered education and physical therapy at 3-months post intervention.

RCT

Table 20.

Evidence Table: Pain Neuroscience Education

Summary:

For patients with chronic musculoskeletal pain, including low back pain, active therapy with pain neuroscience education reduces pain and increases function as compared to active therapy alone.

Good evidence

Evidence statement

Design

Pain neuroscience education combined with a physical intervention is more effective in reducing pain, improving disability, and reducing healthcare utilization compared with either usual care, exercise, other education, or another control group for the treatment of patients with chronic musculoskeletal pain.

Systematic review

Some evidence

Evidence statement

Design

Patients with nonspecific, nonradicular, uncomplicated chronic low back pain may or may not benefit from a 6-week program of biweekly aquatic supervised exercise. They are more likely to experience pain relief and functional benefit from an aquatic program if they first receive two 90-minute sessions of pain neurophysiology education dealing with the role of the brain in pain perceptions, how pain originates in the nervous system, how pain goes from being acute to being chronic, central sensitization, cognitive and behavioral responses related to pain, psychosocial factors affecting pain, and how to manage flare-ups of pain.

RCT

The difference between the pain-education and control group for patients with chronic neck or low back pain reaches clinical relevance for both physical and mental-health domains in 36-item Short Form Health Survey (SF-36) scale and persists at 12 months.

RCT

Among motivated patients presenting with chronic non-specific low back pain, 2 group-based sessions of pain-neurophysiology education (which focused on the explanation and discussion of neurophysiology of pain) in combination with a multimodal exercise program was found to reduce pain and disability up to 3 months post treatment as compared to those participating in a multimodal exercise program alone.

RCT

Section 7.a.ii. Behavioral and Psychological Interventions

Introduction. Psychological therapeutic and diagnostic interventions have selected use in acute pain problems and more widespread use in sub-acute and chronic pain populations. Psychosocial interventions include psychotherapeutic treatments for mental health conditions, as well behavioral medicine treatments. Therapeutic psychological interventions include, but are not limited to, individual counseling and group therapy. Treatment can occur within an individualized model, a multi-disciplinary model, or a structured pain management program.

These interventions may similarly benefit patients without psychiatric conditions but who may need to make major life changes in order to cope with pain or adjust to disability. Health behavior assessment and intervention services are used to identify and address the psychological, behavioral, emotional, cognitive, and interpersonal factors important to the assessment, treatment, or management of physical health problems.

The following commonly used terminology appears in the context of addressing behavioral and psychological interventions:

* biofeedback training, including:

* electromyogram,

* skin temperature,

* respiration feedback,

* respiratory sinus arrhythmia,

* heart rate variability,

* electrodermal response, and

* electroencephalograph;

* cognitive behavioral therapy (CBT);

* mindfulness-based stress reduction;

* progressive relaxation;

* relaxation therapy; and

* sleep hygiene training.

CBT is a psychological therapy that integrates theories of cognition and learning with treatment techniques derived from cognitive therapy and behavior therapy. It assumes that cognitive, emotional, and behavioral variables are functionally interrelated. Treatment is aimed at identifying and modifying the patient's unproductive thought processes and behaviors through cognitive restructuring and behavioral techniques to achieve change. Variations of CBT methods can be used to treat a variety of conditions, including chronic pain, depression, anxiety, phobias, and post-traumatic stress disorder. For patients with multiple diagnoses, more than 1 type of CBT might be needed. A "manualized" approach to CBT follows a specific protocol in a manual. See the Chronic Pain Disorder Medical Treatment Guidelines (MTGs) for additional information on psychological evaluation.

Contraindications / Complications / Side Effects and Adverse Events.

Absolute and Relative Contraindications to Behavioral and Psychological Interventions.

* Contraindications include active suicidality, homicidality, active psychosis, or major untreated psychological comorbidity.

* Relative contraindication includes a lack of patient engagement despite interventions targeting initial resistance.

* Relative contraindications to CBT include literacy below the 6th grade level, lack of English language proficiency, and cognitive impairment.

Side Effects and Adverse Events Related to Behavioral and Psychological Interventions.

* Side effects and adverse events include emotional discomfort, cognitive dissonance, irritability, interpersonal difficulties, or temporary increase in stress.

Recommendations.

Core Requirements.

Recommendation 54. Formal psychological or psychosocial evaluation is recommended as a component of the biopsychosocial approach to patient recovery from physical injury and should attempt to identify both primary psychological risk factors (e.g., psychosis and active suicidality) and secondary psychological risk factors (e.g., moderate depression and job dissatisfaction) (table 21). The evaluation should distinguish between pre-existing, aggravated, and/or purely causative psychological conditions.

Recommendation 55. Comprehensive psychological evaluation must be performed by a psychologist with PhD, PsyD, or EdD credentials or a physician with psychiatric MD/DO credentials.

Recommendation 56. Psychometric testing, distinct from screening psychological questionnaires, must be administered by a psychologist with a PhD, PsyD, or EdD or a health professional working under the supervision of a doctorate level psychologist. A physician with appropriate training may also administer such testing, but interpretation of the tests should be done by a properly credentialed mental health professional.

Recommendation 57. Evaluation for psychiatric medication is permitted if there is an established diagnosis consistent with the standards of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM). See the Medications section.

Recommendation 58. An initial assessment, ongoing assessment, and treatment plan with measurable and clinically meaningful behavioral goals, time frames, and specific planned interventions are required before initiating psychological/psychiatric interventions. Ongoing requirements include:

* a biweekly status report during initial, more frequent treatment and monthly thereafter, documenting progress toward functional recovery;

* a discussion of the psychosocial issues affecting the patient's ability to participate in treatment; and

* addressing pertinent issues such as pre-existing, aggravated, and/or causative issues, as well as realistic functional prognosis.

Recommendation 59. The following is recommended when obtaining a psychological evaluation:

* a full release from the patient prior to evaluation acknowledging that information that may go to the employer, and

* exclusion of sensitive health information not directly related to the work-related conditions in reports sent to the insurer is essential.

CBT Requirements.

Recommendation 60. CBT is recommended for low back pain patients who catastrophize, cope ineffectively with pain, or avoid activity out of fear of re-injury (tables 22, 23).

Recommendation 61. A full psychological evaluation is required before CBT can be initiated.

Recommendation 62. A CBT provider must be a:

* psychologist with PhD, PsyD, or EdD credentials;

* psychiatric MD/DO; or

* licensed mental health or licensed health care provider with training in CBT or certified as a CBT therapist with experience in treating chronic pain disorders who works in consultation with a psychologist with a PhD, PsyD, EdD, or psychiatric MD/DO.

Recommendation 63. A manualized approach to CBT is strongly recommended if it is being performed by a non-mental health professional who is supervised by a psychologist with a PhD, PsyD, EdD, or psychiatric MD/DO provider.

Recommendation 64. Candidates for CBT will have all of the following characteristics:

* adequate literacy level to complete homework that is used to teach inductive rational thinking,

* adequate cognitive and education abilities to meet the requirements of a CBT protocol, and

* otherwise stable social circumstances.

The selection of CBT methods should be based on the individual's literacy level, English proficiency, and cognitive capabilities, as assessed by the behavioral health provider. Individuals who are not candidates for CBT may benefit from other behavioral and psychological approaches.

Biofeedback Requirements.

Recommendation 65. Biofeedback as an adjunct to psychological therapy is recommended for patients who meet 1 of the following indications:

* musculoskeletal injury, in which muscle dysfunction or other physiological indicators of excessive prolonged stress response affects and/or delays recovery;

* a need for training to improve self-management of pain, anxiety, panic, anger or emotional distress, opioid withdrawal, insomnia, sleep disturbance, and/or other central and autonomic nervous system imbalances; and/or motivation to learn and practice biofeedback and self-regulation techniques (table 24).

Recommendation 66. If biofeedback treatment is indicated, it must be done in conjunction with the patient's other psychosocial or medical interventions.

Recommendation 67. Psychologists or psychiatrists who provide psycho-physiological therapy, which integrates biofeedback with psychotherapy, must be either Biofeedback Certification International Alliance (BCIA) certified or practicing within the scope of their training.

* Non-licensed health care providers of biofeedback for chronic pain patients must be BCIA certified and shall have their biofeedback treatment plan approved by the authorized treating psychologist or psychiatrist.

* Biofeedback can also be provided by health care providers who follow a set treatment and educational protocol. Such treatment may utilize standardized material, relaxation recordings, or app-based interventions. App-based interventions must meet the criteria in Rule 18.

Substance Use Disorder Requirements.

Recommendation 68. Patients with substance use disorder, high-dose opioid use, or use of other drugs of abuse may require inpatient and/or outpatient chemical dependency treatment programs before or in conjunction with other interdisciplinary rehabilitation. See the Chronic Pain Disorder Medical Treatment Guidelines (MTGs).

Time Frames.

Time Frames for Behavioral and Psychological Interventions

Time to produce effect (sessions)

Frequency (sessions/week)

Maximum duration

Group CBT

up to 8 (2-hours)

up to 2

16 sessions

Individual CBT

up to 8 (1-hour)

up to 2

16 sessions

Biofeedback

up to 4 sessions

up to 2

12 sessions [UPSILON]

Relaxation

up to 4 sessions

up to 2

12 sessions [UPSILON]

Other psychological interventions

up to 8

up to 2*

6 months [DOUBLE DAGGER]

[UPSILON] Treatment beyond 12 sessions must be documented with respect to need, expectation, and ability to facilitate positive symptomatic and functional gains.

* For the first 2 weeks of treatment, excluding hospitalization, if required; decreasing to weekly in the 2nd month of treatment and then 2-4 times per month (with the exception of exacerbations, which may require increased frequency of visits).

[DOUBLE DAGGER] Longer supervised psychological/psychiatric treatment may be required, especially if there are ongoing medical procedures or complications. If counseling beyond 6 months is indicated, the management of psychosocial risks or functional progress must be documented.

Evidence Tables.

Table 21.

Evidence Table: Psychological Assessments and Outcomes

Summary:

Psychological testing identifies patients most likely to benefit from surgery.

Good evidence

Evidence statement

Design

Psychometric testing can predict medical treatment outcomes.

Cohort study

Some evidence

Evidence statement

Design

Psychological and medical risk factor assessment prior to surgery can identify patients unlikely to benefit from surgery.

Cohort study

Table 22.

Evidence Table: CBT

Summary:

CBT results in reduced pain and disability for patients with subacute and chronic low back pain.

Good evidence

Evidence statement

Design

CBT may reduce pain and disability in patients with chronic pain, but the magnitude of the benefit is uncertain.

Meta analysis

CBT, but not behavioral therapy, shows weak to small effects in reducing pain, and small effects on improving disability, mood, and catastrophizing in the treatment of patients with chronic pain.

Meta analysis

Psychological interventions, especially CBT, are superior to no psychological intervention for chronic low back pain.

Meta analysis

6 group therapy sessions lasting 90 minutes each focused on CBT skills improved function and alleviated pain in uncomplicated sub-acute and chronic low back pain patients.

RCT

A stepped care program is more effective than usual care in veterans with chronic musculoskeletal pain. The stepped care program consisted of 12 weeks during which nurse case managers took a medication use history and adjusted medication dosage and scheduling through telephone contacts with patients every other week, followed by a 12-week step in which cognitive behavioral treatment was administered by 45 minute individual sessions by telephone every other week. Disability and pain interference with daily activity with stepped care were both superior to usual care in which patients were given printed handouts and were followed for all care by their primary treating physicians.

Meta analysis

Some evidence

Evidence statement

Design

A 6-week program of cognitive-behavioral group intervention with or without physical therapy can reduce sick leave, health care utilization, and the risk for developing long-term sick leave disability (> 15 days) in workers with nonspecific low back or neck pain compared with simple verbal instruction by a physician.

RCT

CBT provided in seven 2-hour small group sessions can reduce the severity of insomnia in chronic pain patients.

RCT

Some evidence cont.

Among patients with low back pain who participated in a brief cognitive intervention based on a non-injury model addressing pain and fear avoidance provided over 4 sessions, the addition of either a manualized CBT program or the use of nutritional supplements did not improve on the demonstrated return to work benefit at 12 months post-intervention resulting from the brief cognitive intervention alone.

RCT

10 sessions of group-based multidisciplinary rehabilitation focusing on task-oriented exercises plus 5 sessions of CBT aimed at managing fear-avoidance beliefs over 5 weeks was significantly more effective than traditional exercises in reducing disability, kinesiophobia, pain, catastrophizing, and enhancing the quality of life in patients with chronic low back pain, and the effects lasted for at least 2 years after the end of the intervention.

RCT

The McKenzie approach provides similar outcomes in improving pain, disability, and ability to carry out work activities in comparison with CBT.

RCT

The benefits of CBT continue to be present 3 or more years after the initial intervention, although the differences between CBT and the control group are likely to become narrower with extended follow-up.

RCT

Behavioral modification, such as patient education and group or individual counseling with CBT, can be effective in reversing the effects of insomnia.

RCT

Intensive exercise coupled with CBT is as effective as posterolateral fusion for chronic un-operated low back pain.

RCT

Table 23.

Evidence Table: CBT in the Pre- and Post-Operative Setting

Summary:

A pre-operative program of multidisciplinary CBT focused on information about the fusion op perceptions, coping strategies, and return to activity and work may improve early mobilizatio more rapid reduction in disability up to 3 months after surgery.

eration, pain n and result in

Some evidence

Evidence statement

Design

In patients scheduled for lumbar spinal fusion surgery, a 4-week preoperative program of multidisciplinary CBT, emphasizing the interactions between cognition and pain perception, coping strategies for dealing with pain, pacing principles, return to work, and details about the fusion operation, does not appear to reduce pain scores in the immediate postoperative period. However, such a CBT program as preparation for surgery does appear to be advantageous in the first 3 days after surgery by leading to earlier mobilization and independent ambulation, even though the intensity of pain scores is not significantly reduced.

RCT

Some evidence cont.

CBT also appears to give spinal fusion patients an advantage later in the postoperative surgical period, with a faster decrease in disability scores for at least 3 months following the operation. At 1 year, the difference in disability between CBT and no CBT is no longer significant, but the functional gains from the early postoperative period are maintained.

RCT

Table 24.

Evidence Table: Biofeedback and Relaxation Training

Summary:

Both biofeedback and relaxation therapy reduce pain and disability for patients with chronic low back pain as compared to CBT.

Good evidence

Evidence statement

Design

Biofeedback or relaxation therapy is equal in effect to CBT for chronic low back pain.

Meta analysis

Self-regulatory interventions, such as biofeedback and relaxation training, may be equally effective.

Meta analysis

Some evidence

Evidence statement

Design

Progressive relaxation was the only psychological therapy associated with improvement in function as well as pain intensity compared to wait-list control in chronic low back pain.

Systematic review

Table 25.

Evidence Table: Mindfulness-based Stress Reduction

Summary:

For patients with chronic low back pain, mindfulness-based stress reduction improves function and reduces pain as compared to usual care. A mindfulness-based stress reduction meditation program with yoga results in similar functional improvement and pain reduction as CBT, when each intervention is compared to usual care.

Good evidence

Evidence statement

Design

As compared to usual care for chronic low back pain, mindfulness-based stress reduction reduced pain by 30% and improved function as well.

Systematic review

Good evidence cont.

In the setting of chronic low back pain, an 8-week mindfulness-based stress reduction meditation program with yoga or 8 weeks of CBT resulted in small, significant improvements in physical function and reduction in pain compared to usual care at 26 weeks with no significant differences in outcomes between the 2 treatments.

RCT

Some evidence

Evidence statement

Design

In the setting of chronic low back pain, 8 weeks of CBT resulted in small, significant improvements in physical function compared to usual care at 2 years post treatment with no significant differences between CBT and a mindfulness-based stress reduction meditation program with yoga. No significant differences in pain bothersomeness were shown between CBT, a mindfulness-based stress reduction meditation program with yoga, and usual care at 2 years post treatment.

RCT

Section 7.b. Adjunct Second Line Treatments, as Indicated

Section 7.b.i. Passive Therapies

Introduction. Passive therapies include treatments that do not require a patient's energy expenditure. They are most helpful early in treatment, and they are directed at controlling symptoms and improving the rate of healing soft tissue injuries. They can be used adjunctively with active therapies to help control swelling, pain, and inflammation. The following passive therapies are common treatments:

* acupuncture,

* acupuncture with electrical stimulation,

* iontophoresis,

* joint mobilization,

* low level laser,

* manipulation,

* manual treatment,

* manual traction,

* massage,

* mechanical or motorized traction,

* phonophoresis,

* soft tissue mobilization,

* short-wave diathermy,

* superficial heat and cold therapy,

* trigger point dry needling,

* ultrasound, and

* unattended electrical stimulation (e.g., transcutaneous electrical nerve stimulation [TENS]).

Contraindications / Complications / Side Effects and Adverse Events. Absolute and Relative Contraindications to Passive Therapies.

* High velocity / low amplitude manipulation is contraindicated in those with joint instability, fractures, severe osteoporosis, infection, metastatic cancer, active inflammatory arthritis, aortic aneurysm, and signs of progressive neurologic deficits.

* Relative contraindications to manipulation include spinal stenosis, spondylosis, and disc herniation.

* Manual traction is contraindicated in those with tumor, infection, fracture, or fracture dislocation.

* Non-oscillating inversion traction methods are contraindicated in patients with glaucoma or hypertension.

Complications of Passive Therapies.

* Rare complications of dry needling or acupuncture include pneumothorax, infection, or syncope.

Side Effects and Adverse Events Related to Passive Therapies.

* Acupuncture may result in treatment-related pain or bruising associated with needle insertion.

Recommendations.

Core Requirements.

Recommendation 69. Patients in passive therapy must demonstrate functional progress through validated functional assessment measures. If there is no evidence of functional progress within the time to produce effect, the therapy shall be discontinued and the patient must be referred back to their treating provider for evaluation. Each patient is limited to a maximum of 4 discrete passive therapy trials.

Recommendation 70. Passive therapies must occur concurrently with self-directed exercise or formal active therapy programs (table 26).

Recommendation 71. The frequency of passive therapy must decrease over time.

Recommendation 72. Durations of care beyond those listed as "time to produce effect" and "maximum" are warranted in certain circumstances when treatment to date has resulted in measurable and clinically meaningful functional improvement. These circumstances include:

* re-injury;

* interrupted continuity of care;

* after surgery, particularly multiple surgeries;

* injuries (e.g., fracture); or

* comorbidities.

Specific goals with objective measures of functional improvement must be cited to justify extended durations of care.

Recommendation 73. Manipulation under general anesthesia and manipulation under joint anesthesia are not recommended.

Recommendation 74. Mechanical or motorized traction is not recommended for low back pain patients with or without radicular symptoms (table 31).

Recommendation 75. Due to the absence of quality evidence supporting their use, ultrasound, phonophoresis, low level laser, kinesiotaping, and iontophoresis are not recommended for low back pain.

Time Frames.

Time Frames for Passive Therapies

Time to produce effect (sessions)

Frequency* (sessions/week)

Maximum duration

Mobilization and Manipulation

up to 6

up to 3 times/week

8 weeks

Massage

1

up to 2 times/week

8 weeks

Acupuncture

up to 6

up to 3 times/week

15 treatments

Heat/cold, short-wave diathermy, unattended electrical stimulation (e.g., TENS**)

up to 4

up to 3 times/week

8 weeks

Trigger point / dry needling

up to 4

up to 2 times/week

8 weeks

Traction (manual)***

up to 3

up to 3 times/week

4 weeks

*See recommendation 71 regarding the expected decreasing frequency over time.

**If TENS treatment results in documented functional benefit and is anticipated to extend beyond 4

treatments, consider purchase of a home TENS unit.

***If response is negative after 3 thirty minute treatments, discontinue.

Evidence Tables.

Table 26.

Evidence Summary: Passive Therapies

Passive therapies may provide functional benefit and symptomatic relief in patients with low back pain, especially when paired with an active intervention. The decision to refer a patient for 1 passive therapy over another should be based on patient preference and relative safety, not on the expectation of a greater treatment effect among passive therapy options.

Table 27.

Evidence Table: Manipulation and Mobilization

Summary:

Manipulation and/or mobilization, particularly when combined with exercise, may reduce pain and improve function for patients with low back pain.

Good evidence

Evidence statement

Design

2 sessions of thrust manipulation of the thoracolumbar spine followed by an exercise regimen leads to better low back function at 6 months than oscillatory non-thrust manipulation in patients with subacute low back pain. The study found patients with the following characteristics were likely to benefit from the program: segmental hypomobility, no symptoms distal to the knee, low fear avoidance scores, and preservation of at least 35 degrees of internal rotation in at least 1 hip.

RCT

For acute low back pain, spinal manipulation had greater effects on function than sham manipulation.

For acute low back pain, spinal manipulation did not result in greater pain relief than treatments considered inactive (e.g., an educational booklet, bed-rest) at short term (1-week).

For radicular low back pain, spinal manipulation in combination with home exercise resulted in greater improvement in leg and back pain at 12 weeks as compared to home exercise and advice alone.

Systematic review

Spinal manipulative therapy is comparable to exercise, standard medical care, and physiotherapy in reducing chronic low back pain, and spinal manipulative therapy does not provide clinically important, superior pain relief over these interventions.

Meta analysis

Manipulation does not have a clinically greater therapeutic effect on acute, 6 weeks or less, nonspecific low back pain than other interventions including physical therapy.

Meta analysis

Among people with acute (<6 weeks) low back pain, spinal manipulative therapy was significantly more effective than usual care, physiotherapy, and exercise for short-term pain and functional improvements. However, effects were small, with only transient minor musculoskeletal harms.

Systematic review

Some evidence

Evidence statement

Design

A combination of spinal manipulation and exercise is more effective than exercise alone in reducing pain and improving function of low back pain for 1 year.

RCT

Referral of patients for chiropractic care or McKenzie physical therapy in the first weeks of uncomplicated low back pain adds little to the otherwise favorable prognosis for acute low back pain and does incur additional short-term costs of care.

RCT

6 sessions of osteopathic manual treatment, delivered over a period of 8 weeks, is likely to be an effective intervention for nonspecific, nonradicular, non-traumatic low back pain which has lasted more than 3 months.

RCT

In those who have chronic low back pain, 12 weeks of supervised high-dose exercise, spinal manipulative therapy, or low-dose home exercise with advice are all equally effective for reducing pain in the short- and long-term (1 year).

RCT

Spinal manipulation/mobilization, followed by active exercises, may be effective for the reduction of disability from nonspecific low back pain lasting more than 12 weeks.

RCT

12 sessions of spinal manipulation in 6 weeks from a chiropractor yielded the most favorable pain reduction and functional disability improvement compared to a hands-on control in the short-term (12 weeks) for chronic nonspecific low back pain. However, differences between dosage groups did not meet the predetermined minimally clinical significance standards. There was no significant difference between 12 and 18 sessions of spinal manipulation. Also, at 1 year, there was no significant difference between groups.

RCT

Table 28.

Evidence Table: Massage

Summary:

Massage therapy may reduce pain and improve function in patients with subacute and chronic low back pain, particularly when combined with exercise.

Good evidence

Evidence statement

Design

Massage therapy in combination with exercise reduces pain and improves function short-term for patients with subacute low back pain.

Systematic review

Some evidence

Evidence statement

Design

In the setting of acute uncomplicated low back pain, treatment with manual pressure at myofascial trigger points up to six 15-minute sessions over 2 weeks reduces back pain more effectively than manual pressure 30 mm away from myofascial trigger points and more effectively than conventional low back massage (effleurage).

RCT

In patients with chronic low back pain, craniosacral therapy or classic massage are equally effective in reducing disability after 10 weekly sessions of treatment and at 1 additional month of follow-up.

However, since both groups received an intervention, the trial does not address the question of the effect of these treatments in comparison to usual care.

RCT

Among those with chronic low back pain, a 10-week course of relaxation massage is equally effective when compared to structural massage in improving functional disability and reducing pain. Both techniques are more effective than usual care and benefits persist for at least 6 months.

RCT

There were no clear differences in pain or function between foot reflexology and usual care (or sham foot massage) in chronic low back pain.

Systematic review

Table 29.

Evidence Table: Acupuncture

Summary:

True and sham acupuncture improves function in patients with chronic low back pain as compared to usual care. Acupuncture reduces pain in patients with acute low back pain, as compared to sham acupuncture. It also provides short-term relief in patients with chronic low back pain, as compared to sham acupuncture. Individuals with positive expectations of acupuncture likely experience enhanced treatment benefit.

Good evidence

Evidence statement

Design

For acute low back pain, acupuncture decreased pain intensity more than sham acupuncture with nonpenetrating needles.

Acupuncture was associated with a greater likelihood of improvement at the end of treatment as compared to NSAIDs.

For chronic low back pain, acupuncture was associated with lower pain intensity and better function after the intervention as compared to no acupuncture.

For chronic low back pain, acupuncture also decreased pain intensity more than sham acupuncture in the immediate time-frame.

Systematic review

There is a likely, small clinical benefit of acupuncture for acute low back pain, and it may be considered an alternative for some patients.

Systematic review

Acupuncture is effective in the treatment of low back pain in patients with positive expectations of acupuncture.

RCT

Good evidence cont.

Acupuncture, true or sham, is superior to usual care for the reduction of disability and pain in patients with chronic nonspecific low back pain, but true and sham acupuncture are likely to be equally effective.

RCT

Acupuncturists must be properly trained in aseptic technique.

Systematic review

Some evidence

Evidence statement

Design

Acupuncture is better than no acupuncture for axial chronic low back pain.

RCT

Among those with nonspecific low back pain, the use of integrated therapy consisting of acupuncture combined with conventional medical care appears to be more effective than conventional medical care alone.

Systematic review

Table 30.

Evidence Table: Laser Acupuncture

Good evidence

Evidence statement

Design

In the setting of chronic nonspecific low back pain, 8 weekly sessions of high dose laser acupuncture at a dose of 0.8 Joules per acupuncture point are not more effective than a low dose laser at a dose of 0.2 Joules per acupuncture point or a sham laser treatment at a dose of 0 Joules.

RCT

Table 31.

Evidence Table: Traction

Summary:

Traction offers no clinical benefit for patients with radicular or non-radicular low back pain.

Good evidence

Evidence statement

Design

Mechanical traction is not useful for low back pain patients with sciatica nor those with low back pain without radicular symptoms.

Systematic review

Some evidence

Evidence statement

Design

Intervertebral lumbar traction does not add significantly to a graded activity program for resolution of non-radicular chronic low back pain.

RCT

Table 32.

Evidence Table: Electrical Therapies

Good evidence

Evidence statement

Design

Percutaneous electrical nerve stimulation (PENS) produces improvement of pain and function compared to placebo; however, there is no evidence that the effect is prolonged after the initial 3 week treatment episode.

RCT

Some evidence

Evidence statement

Design

Among patients with chronic nonspecific low back pain, 5 days of anodal transcranial direct current stimulation compared with sham stimulation did not result in pain or disability reduction, alone or when combined with a 4-week cognitive behavioral management program.

RCT

Section 7.b.ii. Durable Medical Equipment

Introduction. Durable medical equipment includes devices that can be used repeatedly to serve a medical purpose. These include braces or splints for supporting, immobilizing, or treating muscles, joint, or skeletal parts that are weak, ineffective, deformed, or injured.

Contraindications / Complications / Side Effects and Adverse Events.

Absolute and Relative Contraindications of Durable Medical Equipment.

* Deconditioning of the lumbar musculature and associated fatigue or pain.

* Skin irritation resulting from contact with the orthotic.

Recommendations.

Foot Orthotics Requirements.

Recommendation 76. Foot orthotics and shoe inserts are appropriate for patients with spinal disorders attributed to aggravated mechanical abnormalities, such as leg length discrepancy, scoliosis, or lower extremity misalignment.

Lumbar Support Devices Requirements.

Recommendation 77. If lumbosacral support devices (e.g., lumbar corsets, braces, sacroiliac [SI] belts, and back belts) are used, the provider must educate the patient about potential for disuse and deconditioning of the lumbar musculature, skin irritation, and general discomfort. Documentation should include directions for duration and frequency of use.

Recommendation 78. Thoracolumbar orthotics are acceptable in the treatment of burst fractures (table 33).

Evidence Table.

Table 33.

Evidence Table: Orthotics in the Treatment of Burst Fractures

Summary:

For thoracolumbar burst fractures or compression fractures with intact posterior elements and neurological compromise, nonoperative management may be superior to instrumented fusion. with or without a brace may lead to similar improvements. Treatment should include appropria restrictions in the first 4-8 weeks, progressing to active therapies and returning to normal activ

no

Treatment te ity.

Some evidence

Evidence statement

Design

In the setting of stable thoracolumbar burst fractures when there is no neurological compromise of lower extremities, bowel, or bladder, there is a lack of evidence that surgical intervention with multilevel posterior or anterior instrumented stabilization offer any advantages over conservative management with postural reduction and early bracing and mobilization in the first 2 to 4 years of follow-up. However, surgical treatment has a higher rate of subsequent surgery than conservative treatment.

Systematic review

In the long term of 16 to 20 years, pain and disability are distinctly superior with nonoperative management with a brace or cast than with instrumented fusion.

Systematic review

For neurologically intact patients who have sustained an isolated thoracolumbar burst fracture grade AO-A3, which results in retropulsion of bone into the spinal canal but spares the posterior longitudinal ligament and other posterior elements of the spine, treatment with and without a thoracolumbosacral orthosis offer equivalent benefits.

Treatment without an orthosis involves immediate mobilization as tolerated, supervised by a physical therapist, using restrictions to limit bending and rotating through the trunk, with encouragement to return to normal activities

RCT

within 8 weeks. Lifting and carrying restrictions of 5 kg and restrictions of 90° hip flexion should be done for the first 8 weeks. Isometric spine stabilization exercises should begin at 4 weeks, progressing to isotonic exercises at 8 weeks, and occupation-specific rehabilitation at 9 weeks.

In the setting of acute vertebral compression fractures with intact posterior elements and the absence of neurological deficits, treatment with no brace is not inferior to treatment with a soft brace or treatment with a rigid brace; all 3 treatments lead to similar improvements in disability and pain during the 12 weeks after the onset of the fracture.

RCT

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