Code of Colorado Regulations
1100 - Department of Labor and Employment
1101 - Division of Workers' Compensation
7 CCR 1101-3 R17 Ex 01 - Rule 17, Exhibit 1 - LOW BACK PAIN MEDICAL TREATMENT GUIDELINES
Section 7 CCR 1101-3-17-01-9 - Medications
Current through Register Vol. 47, No. 17, September 10, 2024
Introduction. Medications are used in the treatment of low back injuries to control acute pain, chronic pain, and inflammation. Use of medications will vary widely due to the spectrum of injuries. If medications are being considered for long-term chronic pain management, refer to the Chronic Pain Disorder Medical Treatment Guidelines (MTGs) medication section.
Contraindications / Complications / Side Effects and Adverse Events.
* See the specific medication section. The medication lists within these sections do not provide complete information on side effects, potential complications, drug interactions, or drug monitoring. For more complete information, refer to the Chronic Pain Disorder MTGs medication section or a medication reference text.
Recommendations.
Core Requirements.
Recommendation 179. Medication reconciliation is required at the initial visit and periodically during treatment to avoid medication errors and to discuss side effects, drug interactions, and expected functional goals. Reconciliation includes the following elements:
* current medication name, dosage, frequency, and route;
* patient understanding of indication;
* potential interaction of prescription and over the counter medications;
* drug allergies;
* comorbid medical issues;
* history of substance abuse; and
* checking the Colorado Prescription Drug Monitoring Program (PDMP).
The medications documented as a part of the reconciliation will reflect those that the provider deems directly relevant to the claim-related condition.
Recommendation 180. A therapeutic trial of medications is recommended to evaluate the effect on functional status. The length of a medication trial will depend on the individual medication, and the patient should be informed on the time to expected benefit. If no functional benefit is observed at that time, the medication should be discontinued.
Recommendation 181. Medications should be initiated at the lowest dose expected to result in functional improvement and then titrated based on clinical response.
Evidence Tables. None. The above recommendations were based on consensus.
Section 9.a. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Acetaminophen
Introduction. Non-steroidal anti-inflammatory drugs (NSAIDs) are medications for low back pain and inflammation. Acetaminophen is an analgesic commonly used to treat mild pain.
Contraindications / Complications / Side Effects and Adverse Events.
Absolute and Relative Contraindications to Acetaminophen and NSAIDs.
* Acetaminophen
* Concomitant use of other drug products containing acetaminophen exceeding the maximum recommended daily dose of acetaminophen.
* Allergy to acetaminophen or any of the inactive ingredients.
* Use with caution in patients with alcoholic liver disease, patients with hepatic impairment or active liver disease, and patients with known glucose-6-phosphate-dehydrogenase
(G6PD) deficiency.
* NSAIDs (table 81)
* Comorbid conditions that result in an increased risk for gastrointestinal (GI), renal, or cardiovascular adverse reactions.
* Patients at risk for GI bleeding, including patients who use alcohol, smoke, are older than 65 years old, take corticosteroids or anti-coagulants, and patients on longer durations of therapy.
* Celecoxib is contraindicated in sulfonamide allergic patients.
* Contraindicated in patients with aspirin-exacerbated respiratory disease due to cross-reactivity risk and potential for a severe asthma attack.
* Topical salicylate and non-salicylate medications may result in alterations in bleeding time; they should be used with caution in patients on warfarin therapy.
Side Effects and Adverse Events Related to Specific Classes of Acetaminophen and NSAIDs.
* Acetaminophen may result in hepatotoxicity, and chronic use may result in chronic kidney disease, hypersensitivity or anaphylactic reactions, serious and potentially fatal skin reactions, hypertension, chronic daily headaches, and peptic ulcer disease.
* NSAIDs may result in abnormal or worsening renal function, including renal failure; abnormal liver function; GI bleeding, particularly in patients at higher risk for a bleed; increased risk of cardiovascular events; gastric or duodenal perforation and ulceration; anaphylactoid reaction; platelet function abnormalities; and fluid retention and edema. Postoperative NSAIDs may increase the risk of nonunion at higher doses (table 85).
* Topical agents may result in localized skin reactions.
Recommendations.
Core Requirements.
Recommendation 182. Acetaminophen or NSAIDs are recommended for initial analgesic treatment of uncomplicated low back pain (tables 82, 83).
Recommendation 183. Co-prescription of a proton pump inhibitor, histamine H2-receptor antagonists (H2-blockers), or prostaglandin analog with NSAIDs is recommended to reduce risk of duodenal or gastric ulceration in patients with concurrent antiplatelet or corticosteroid therapy.
Recommendation 184. Cyclooxygenase-2 (COX-2) inhibitors are not recommended as a first-line agent for short-term use in low-risk patients, but they can be used for patients who do not tolerate traditional NSAIDs.
Recommendation 185. Topical NSAIDs are recommended when oral NSAID use is contraindicated due to systemic side effects. It must be started with the lowest dose expected to result in functional improvement and then titrated until functional improvement is noted (table 84).
Recommendation 186. Perioperative use of acetaminophen and/or NSAIDs, either alone or in combination with other medications, to optimize analgesia is recommended (table 85).
Recommendation 187. See the Chronic Pain Disorder MTGs medication section if acetaminophen or NSAIDs are being considered for long-term use.
Time Frames.
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Time Frames for Medications |
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|
Optimum duration |
Maximum duration |
|
|
Acetaminophen |
up to 10 days |
Extended use on a case-by-case basis* |
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NSAIDs |
7 days |
1 year* |
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*Use of this substance long-term (for 3 days per week or greater) may be associated with rebound pain upon cessation. |
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Evidence Tables.
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Table 81. Evidence Table: Adverse Events and NSAIDs |
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Good evidence |
Evidence statement |
Design |
|
Naproxen has a more favorable cardiovascular profile than other NSAIDs when used over a long period for chronic pain. |
Meta analysis |
|
|
For general low back pain, specific adverse effects of dyspepsia and GI bleeding were more frequent with NSAIDs than placebos. |
Systematic review |
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Celecoxib in a dose of 200 mg per day, administered over a long period, does not have a worse cardiovascular risk profile than naproxen at a dose of up to 1000 mg per day or ibuprofen at a dose of up to 2400 mg per day. |
RCT |
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|
Celecoxib has a more favorable safety profile than ibuprofen or naproxen with respect to serious GI adverse events, and has a more favorable safety profile than ibuprofen with respect to renal adverse events. |
RCT |
|
|
Some evidence |
Evidence statement |
Design |
|
Fewer adverse events occurred in NSAIDs treatment arms as compared to placebo in patients experiencing chronic low back pain. |
Systematic review |
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Table 82. Evidence Table: Acetaminophen |
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Summary: For acute nonspecific low back pain, acetaminophen and placebo provide similar pain relief and functional improvement. While acetaminophen as a monotherapy is not superior to placebo, its use as 1 component of a multimodal analgesic regimen is generally accepted. |
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Strong evidence |
Evidence statement |
Design |
|
In the setting of acute nonspecific low back pain, acetaminophen at a dose of up to 4 grams per day is no more effective than placebo for pain relief and for improvement of disability. |
Meta analysis |
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Table 83. Evidence Table: NSAIDs for Low Back Pain |
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Summary: NSAIDs may reduce acute low back pain and short term disability when compared to placebo, but the clinical benefit is small. |
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Good evidence |
Evidence statement |
Design |
|
In the setting of acute low back pain lasting less than 12 weeks, NSAIDs lead to a small reduction in short term pain intensity, approximately 10 points on a 100 point scale, compared to placebo. |
Meta analysis |
|
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In the setting of acute low back pain lasting less than 12 weeks, NSAIDs lead to a small reduction in short term disability, approximately 2 points on a 24 point scale, compared to placebo. |
Meta analysis |
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For recent low-back pain, oral NSAIDs are equally effective as placebo or muscle-relaxants. |
Systematic review |
|
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For persistent low back pain, oral NSAIDs are more effective than placebo or acetaminophen. |
Systematic review |
|
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Some evidence |
Evidence statement |
Design |
|
NSAIDs are not more beneficial than placebo when evaluating pain-intensity and disability outcomes; the change in these scores does not reach a minimal clinical important difference in patients experiencing chronic low back pain. |
Systematic review |
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Table 84. Evidence Table: Topical NSAIDs for Analgesia |
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Summary: Topical NSAIDs are more effective than placebo for acute musculoskeletal injuries and have fewer systemic adverse events than oral NSAIDs. |
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Strong evidence |
Evidence statement |
Design |
|
Topical NSAIDs are more effective than placebo vehicles, such as gels or creams, in the setting of acute musculoskeletal injuries. |
Meta analysis |
|
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Some evidence |
Evidence statement |
Design |
|
Topical NSAIDs are associated with fewer systemic adverse events than oral NSAIDs. |
Meta analysis |
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Table 85. Evidence Table: Perioperative Medication Use for Optimal Analgesia |
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Summary: For patients undergoing spinal fusion surgery, preoperative analgesia may reduce postoperative pain and opioid use. Postoperative NSAIDs may increase the risk of nonunion at higher doses. |
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Good evidence |
Evidence statement |
Design |
|
In the setting of lumbar spinal fusion, NSAIDs at an equivalence of no more than 120 mg of ketorolac for 14 days postoperatively do not appear to increase the risk of nonunion of the operated spinal segment. |
Systematic review |
|
|
Some evidence |
Evidence statement |
Design |
|
In the setting of posterior lumbar interbody fusion (PLIF) surgery, a single saline infusion of 800 mg of ibuprofen one half hour prior to surgery may lead to less pain and morphine use in the immediate postoperative period and may thereby be an option for preoperative care of the surgical patient. |
RCT |
|
|
In the setting of 1-level or 2-level spinal fusion surgery, the administration of preemptive analgesia 8 hours preoperatively with acetaminophen, ketorolac, and pregabalin may confer benefits in the 48 hours following the procedure in the form of less pain, better ambulation, and less morphine use. |
RCT |
|
|
Among patients undergoing posterior lumbar spinal fusion, the addition of preemptive analgesia using a single intravenous dose of ketorolac (30 mg) or parecoxib (40 mg) resulted in better immediate postoperative pain control as compared to a control (saline) group. However, the difference among the groups did not persist in measures from one-hour post-operatively up to 24 hours. There was no apparent opioid-sparing effect with preemptive analgesia. |
RCT |
|
|
In the setting of lumbar fusion without bone morphogenetic protein (BMP), postoperative NSAIDs with an equivalent dose of more than 300 mg of diclofenac are associated with an increased risk of nonunion of the operated spinal segment. There appears to be a dose-dependent effect of postoperative NSAIDs on the risk of nonunion. |
Systematic review |
|
Section 9.b. Muscle Relaxants
Introduction. Muscle relaxants are a heterogeneous class of medications with varying mechanisms of action used to treat muscle spasm associated with low back injury.
Contraindications / Complications / Side Effects and Adverse Events.
Absolute and Relative Contraindications to Muscle Relaxants.
* Cyclobenzaprine should not be used when a patient has a history of cardiac dysrhythmia or when there is concurrent use of monoamine oxidase inhibitors.
* Metaxalone should not be used when there is a history of significantly impaired renal or hepatic disease, pregnancy, and predisposition to drug induced hemolytic anemia.
* Methocarbamol should not be used when the patient has a hypersensitivity to the medication or there is possible renal compromise.
* Tizanidine should not be used when there is concurrent use of ciprofloxacin or fluvoxamine or hepatic disease.
Side Effects and Adverse Events Related to Muscle Relaxants.
* Cyclobenzaprine may cause sedation, anticholinergic reactions, and blurred vision. Patients should also be monitored for suicidal ideation and drug abuse.
* Metaxalone may cause sedation and hematologic abnormalities.
* Methocarbamol may cause decreased cognition, lightheadedness, and GI side effects.
* Tizanidine may cause hypotension, sedation, hepatotoxicity, hallucinations, psychosis, and dry mouth.
Recommendations.
Core Requirements.
Recommendation 188. Muscle relaxants may be used as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful, musculoskeletal conditions (table 86).
Recommendation 189. Tizanidine (alpha-2 adrenergic agonist) is only approved by the Food and Drug Administration (FDA) for the treatment of true centrally mediated spasticity associated with musculoskeletal disorders. Use for musculoskeletal conditions, such as neck or back pain, would be "off label."
Recommendation 190. Benzodiazepines are not recommended for use in combination with opioids due to the elevated risk of death due to respiratory depression.
Recommendation 191. See the Chronic Pain Disorder MTGs medication section if muscle relaxants are being considered for long-term use.
Time Frames.
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Time Frames for Muscle Relaxants |
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Optimum duration |
Maximum duration |
|
1 week |
2 weeks[DAGGER] |
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[DAGGER]or longer, if only used at night. |
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Evidence Tables.
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Table 86. Evidence Table: Muscle Relaxants |
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Summary: For patients with acute low back pain, muscle relaxants provide greater short-term pain relief than placebo. However, they do not provide additional benefit over NSAIDs alone, and they increase adverse events. |
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Strong evidence |
Evidence statement |
Design |
|
Non-benzodiazepine muscle relaxants are more effective than placebo for providing short-term pain relief in acute low back pain. They should be used with caution because of central nervous system side effects. |
Meta analysis |
|
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Good evidence |
Evidence statement |
Design |
|
In patients with acute nontraumatic musculoskeletal low back pain who have optimized their use of NSAIDs such as naproxen, the addition of cyclobenzaprine 5mg to be taken as needed adds no significant functional benefit in the short term, but it does increase the frequency of adverse events such as dizziness, drowsiness, and GI side effects. |
RCT |
|
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Good evidence cont. |
In the setting of acute nonradicular, nontraumatic musculoskeletal low back pain of 2 weeks duration or less, the addition of diazepam to naproxen adds no additional pain relief or reduction of functional disability beyond that of placebo. |
RCT |
Section 9.c. Oral Steroids
Introduction. Oral steroids are used for pain and inflammation.
Contraindications / Complications / Side Effects and Adverse Events.
Absolute and Relative Contraindications to Oral Steroids.
* Absolute and relative contraindications include poorly controlled diabetes mellitus or hypertension; heart failure with peripheral edema; cataract or glaucoma; peptic ulcer disease; presence of injection; and low bone mineral density or osteoporosis.
Complications of Oral Steroids.
* Complications include gastritis, ulcer formation, and GI bleeding.
Side Effects and Adverse Events Related to Oral Steroids.
* Side effects and adverse events fluid retention, mood disturbance, and hyperglycemia.
Recommendations.
Core Requirements.
Recommendation 192. Oral steroids are not recommended for the treatment of acute low back pain with or without radiculopathy (table 87).
Evidence Tables.
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Table 87. Evidence Table: Oral Steroids for Acute Low Back and/or Radicular Pain |
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Summary: For patients with acute low back pain with or without radicular pain, oral steroids do not provide clinically important improvements in function or pain, nor reductions in the rate of surgery. They also increase the risk for serious adverse effects. |
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Good evidence |
Evidence statement |
Design |
|
In patients with an acutely herniated lumbar disc with radicular symptoms, a 15-day course of tapering oral prednisone may produce a small improvement in spine function compared to placebo, but this improvement is of very uncertain clinical importance. Also, there is no evidence that oral prednisone reduces the rate of back surgery in the following year. The benefits of a small functional improvement should be weighed against the frequent occurrence of steroid-related adverse effects such as insomnia, nervousness, and increased appetite. There is no evidence that oral prednisone reduces sciatica pain compared to placebo. |
RCT |
|
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Good evidence cont. |
In patients who have not taken oral steroids in the past year, short-term use of an oral steroid can increase the risk of fracture, sepsis, and venous thromboembolism in the subsequent 5 to 90 days, with the greatest increased risk occurring in the first 5-30 days after the prescription is filled. |
Cohort study |
|
Some evidence |
Evidence statement |
Design |
|
Among patients presenting to the emergency department with acute onset of musculoskeletal or radicular low back pain or acute exacerbation of chronic low back pain, a 5-day course of 50 mg oral prednisone results in similar pain reduction at 5 days post-discharge when compared to a placebo given over 5 days. |
RCT |
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A short course of oral corticosteroids, lasting 14 days or fewer, is associated with an increased incidence of GI bleeding, sepsis, and heart failure in the period following their administration. |
Cohort study |
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Table 88. Evidence Table: Other Medications |
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Strong evidence |
Evidence statement |
Design |
|
Bisphosphonates taken alone or in combination with calcium and/or vitamin D are more beneficial than placebo taken alone or with calcium and/or vitamin D for the prevention and treatment of spinal glucocorticoid induced osteoporosis, with data extending to 24 months of use. |
Systematic review |
|
Section 9.d. Gabapentinoids
Introduction. Gabapentinoids are anticonvulsant and nerve pain medications that may be used to treat neuropathic symptoms. They include gabapentin and pregabalin.
Contraindications / Complications / Side Effects and Adverse Events.
Absolute and Relative Contraindications to Gabapentinoids.
* Renal insufficiency is a relative contraindication to gabapentin use, but dosage can be adjusted to accommodate use in the setting of renal dysfunction.
Side Effects and Adverse Events Related to Gabapentinoids.
* Gabapentinoids may cause dizziness, sedation, and respiratory depression in older patients who receive gabapentin along with other analgesics or sedatives.
* Coadministration of opioids and pregabalin or gabapentin may increase the risk of opioid related mortality.
* Gabapentinoids may be associated with an increased risk of mental health disturbance (e.g., depression, suicide), unintentional overdose, and motor vehicle accidents.
Recommendations.
Core Requirements.
Recommendation 193. A trial of oral gabapentin, with a goal of using the lowest dose expected to result in functional improvement, can be a first line intervention before an epidural steroid injection (ESI) for a patient who meets the acute ESI indications but wishes to avoid ESI (table 89). See the Epidural Steroid Injection section.
Recommendation 194. Perioperative use of gabapentin, either alone or in combination with other medications, to optimize analgesia is recommended (table 90).
Recommendation 195. If a gabapentinoid is being considered for long-term, chronic pain management, refer to the Chronic Pain Disorder MTGs medication section.
Evidence Tables.
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Table 89. Evidence Table: Gabapentinoids |
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Summary: For patients with lumbosacral radiculopathy due to herniated disc or spinal stenosis, oral gabapentin is equally effective at reducing leg pain as ESI. This finding is limited because the interventions were not compared to placebo and were not paired with physical therapy. |
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Strong evidence |
Evidence statement |
Design |
|
Gabapentin is more effective than placebo in the relief of painful diabetic neuropathy and postherpetic neuralgia. |
Meta analysis |
|
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Good evidence |
Evidence statement |
Design |
|
In the setting of lumbosacral radiculopathy from herniated disc or spinal stenosis, oral gabapentin without physical therapy and an ESI without physical therapy are approximately equally effective in the first 3 months, but no conclusions can be supported that either intervention is superior to placebo. |
RCT |
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Table 90. Evidence Table: Perioperative Gabapentin Use |
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Summary: For patients undergoing spinal surgery, preoperative gabapentin may reduce postoperative pain and opioid use, without increasing complications. |
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Some evidence |
Evidence statement |
Design |
|
The preoperative administration of gabapentin in doses as low as 300 mg may reduce postoperative pain and opioid consumption in the setting of spinal laminectomy and fusion. |
RCT |
|
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The incidence of many postoperative complications such as nausea, headache, and dizziness is probably similar for gabapentin and placebo. Gabapentin may increase somnolence but may decrease the incidence of urinary retention and pruritus. |
RCT |
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Some evidence cont. |
In patients with chronic lumbosacral radiculopathy undergoing lumbar spinal operation, combined administration of pregabalin and dexamethasone conferred a significant reduction in rescue analgesic requirement up to 2 days postoperatively compared to placebo. |
RCT |
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In the setting of 1-level or 2-level spinal fusion surgery, the administration of pre-emptive analgesia 8 hours preoperatively with acetaminophen, ketorolac, and pregabalin may confer benefits in the 48 hours following the procedure in the form of less pain, better ambulation, and less morphine use. |
RCT |
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Section 9.e. Antidepressants
Introduction. Antidepressants are used for the treatment of pain, dysesthesias, sleep disorders, and depression. If medications are being considered for chronic pain management, refer to the Chronic Pain Disorder MTGs medication section.
Contraindications / Complications / Side Effects and Adverse Events.
Absolute and Relative Contraindications to Antidepressants.
* Tricyclic antidepressants should be avoided in patients with the following:
* at risk of unintentional overdose;
* heart disease;
* underlying cardiac conduction system disease;
* dysrhythmia;
* prostatic hypertrophy;
* at risk for suicide;
* uncontrolled hypertension or orthostatic hypotension;
* those 65 years or older, particularly if a fall risk; and
* seizure disorder.
* Serotonin norepinephrine reuptake inhibitors (SNRIs) should not be used in patients with seizures or eating disorders.
Complications of Antidepressants.
* Tricyclic antidepressants may cause acute hepatitis, neuroleptic malignant syndrome, and tardive dyskinesia.
* SNRIs may result in serotonin syndrome.
* Venlafaxine may cause hypertension, glaucoma, sexual dysfunction, and cardiac issues.
Side Effects and Adverse Events Related to Antidepressants.
* Tricyclic antidepressants (e.g., amitriptyline, nortriptyline) may cause anticholinergic effects (e.g., sedation, dry mouth and associated periodontal conditions, orthostatic hypotension, constipation, urinary retention); decreased seizure threshold; sexual dysfunction; diaphoresis; tremor; antihistamine effects; alpha-1-adrenergic receptor blockade; and cardiac effects, including increasing intraventricular conduction, prolonged QT interval, prolonged conduction through the atrioventricular node.
* SNRIs (e.g., duloxetine, venlafaxine) may cause nausea, dizziness, sweating, loss of appetite, dry mouth, insomnia, drowsiness, constipation, abnormal bleeding, fatigue, sexual dysfunction, and suicidal ideation and attempts in adolescents and young adults.
Recommendations.
Core Requirements.
Recommendation 196. Tricyclic antidepressants are the recommended first-line agent for neuropathic pain, particularly in the setting of insomnia, but they are not recommended as a first-line agent for depression.
Recommendation 197. SNRIs are recommended as a second-line agent for neuropathic pain if a tricyclic offers inadequate relief. However, duloxetine may be considered a first-line agent for a patient who is a candidate for pharmacologic treatment of both chronic pain and depression.
Recommendation 198. Selective serotonin reuptake inhibitors (SSRIs) are recommended for treating depression, but they are not recommended for neuropathic pain.
Recommendation 199. Evaluation and ongoing monitoring for suicidal ideation and mood swings are required for all patients being considered for antidepressant medications.
Recommendation 200. A screening electrocardiogram may be indicated for select patients prior to initiating treatment with a tricyclic or SNRI antidepressant to assess cardiovascular risk.
Time Frames.
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Time Frames for Antidepressant Medications |
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Optimum duration |
Maximum duration |
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up to 6 months |
up to 12 months, with monitoring |
Evidence Tables. None. The above recommendations were based on consensus.
Section 9.f. Opioids
Introduction. Opioids are powerful analgesics reserved for severe, acute pain associated with major trauma, burn, sickle cell disease, and end-of-life cancer pain. If opioid medications are being considered for chronic pain management, refer to the Chronic Pain Disorder MTGs medication section.
Contraindications / Complications / Side Effects and Adverse Events.
Absolute and Relative Contraindications to Opioids.
* Opioids should not be prescribed with benzodiazepines, antihistamines, or other central nervous system depressants or when the history is consistent with regular alcohol or other substance use.
* Tramadol should be used with caution in patients who have a history of seizures, are taking medications that lower the seizure threshold, or are taking medications that impact serotonin reuptake and could increase the risk for serotonin syndrome, such as monoamine oxidase inhibitors, SSRIs, selective serotonin agonists (triptans), tricyclic antidepressants, and alcohol. Also use caution in patients who are taking medications that result in QT prolongation. Tramadol has been associated with death in those with an emotional disturbance or concurrent use of alcohol and other opioids. Significant renal and hepatic dysfunction requires dosage adjustment.
Side Effects and Adverse Events Related to Opioids.
* Opioid medications may commonly cause nausea, vomiting, drowsiness, unsteadiness, constipation, and confusion. Occasional side effects include dry mouth, sweating, pruritus, hallucinations, and myoclonus. Adverse events include opioid-induced hyperalgesia, respiratory depression, dependence, opioid use disorder, overdose, or death. Prolonged opioid use may result in hypogonadism (tables 91, 92). Abrupt discontinuation may precipitate withdrawal.
* Certain comorbid medical conditions can increase the risk for opioid overdose (e.g., obesity, pulmonary disease, obstructive sleep apnea, congestive heart failure, history of alcohol or substance use disorder, advanced age, renal or hepatic dysfunction).
Recommendations.
Core Requirements.
Recommendation 201. Opioid medications are not generally recommended for the treatment of low back pain. Rare exceptions include either of the following:
* acute, severe functionally limiting pain in a patient for whom other non-opioid medications are contraindicated; or
* acute, severe functionally limiting pain that is refractory to non-opioid medications and nonpharmacologic treatment and an absence of risk factors for potential misuse or abuse (table 93).
Recommendation 202. Long-acting opioids are not recommended for the treatment of acute, subacute, or postoperative pain.
Recommendation 203. Opioid medications, including tramadol, are not generally recommended for use in patients with a history of opioid dependence. However, if an opioid medication is deemed clinically appropriate, a referral to a pain specialist is permitted.
Short-term Prescribing Requirements.
Recommendation 204. Prior to dispensing an opioid medication, the following steps are required:
* documented results of a rapid risk assessment for developing opioid use disorder (e.g., Opioid Risk Tool [ORT]),
* risk assessment of developing opioid related adverse events,
* review data on the Colorado PDMP,
* education on the short- and long-term risks and side effects of opioid therapy,
* realistic goals of opioid therapy and the anticipated course of recovery,
* establish the lowest effective dose and shortest duration of therapy,
* education on the safe storage and disposal of opioid medications, and
* develop a discontinuation plan for opioids prior to prescribing.
Prescribing Requirements Beyond 7 Days.
Recommendation 205. Whenever opioids are prescribed for more than 7 days, providers must follow all recommendations for screening and follow-up of chronic pain use. See the Chronic Pain Disorder MTGs.
Time Frames.
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Time Frames for Opioids |
|
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Optimum duration |
Maximum duration |
|
<= 3 days |
7 days[DOUBLE DAGGER] |
|
[DOUBLE DAGGER]Whenever there is use of opioids for > 7 days, providers should follow all recommendations for screening and follow-ups of chronic pain use. |
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Evidence Tables.
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Table 91. Evidence Table: Risk of Initiating Opioid Medications |
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Summary: Short-term opioid prescriptions increase the risk of disability and the risk of developing an opioid use disorder. The use of 50 morphine milligram equivalents (MME) or greater average daily dose or the use of long-acting opioids increases the risk of opioid-related death. |
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Good evidence |
Evidence statement |
Design |
|
In the setting of common low back injuries, when baseline pain and injury severity are taken into account, a prescription for more than 7 days of opioids in the first 6 weeks is associated with an approximate doubling of disability 1 year after the injury. |
Cohort study |
|
|
In the setting of new onset chronic noncancer pain, there is a clinically important relationship between opioid prescription and subsequent opioid use disorder. Compared to no opioid use, short-term opioid use approximately triples the risk of opioid use disorder in the next 18 months. Use of opioids for over 90 days is associated with very pronounced increased risks of the subsequent development of an opioid use disorder, which may be as much as 100-fold when doses greater than 120 MME are taken for more than 90 days. The absolute risk of these disorders is very uncertain but is likely to be greater than 6.1% for long duration treatment with a high opioid dose. |
Cohort study |
|
|
In generally healthy patients with chronic musculoskeletal pain, treatment with long-acting opioids, compared to treatments with anticonvulsants or antidepressants, is associated with an increased risk of death of approximately 69%, most of which arises from non-overdose causes, principally cardiovascular in nature. The excess cardiovascular mortality principally occurs in the first 180 days from starting opioid treatment. |
Cohort study |
|
|
Prescription opioids in excess of 200 MME average daily doses are associated with a near tripling of the risk of opioid-related death, compared to average daily doses of 20 MME. Average daily doses of 100-200 mg and doses of 50-99 mg per day may be associated with a doubling of mortality risk, but these risk estimates need to be replicated with larger studies. |
Cohort study |
|
|
Some evidence |
Evidence statement |
Design |
|
Compared to an opioid dose under 20 MME per day, a dose of 20-50 mg nearly doubles the risk of death, a dose of 50 to 100 mg may increase the risk more than fourfold, and a dose greater than 100 mg per day may increase the risk as much as sevenfold. However, the absolute risk of fatal overdose in chronic pain patients is fairly low, and may be as low as 0.04%. |
Cohort study |
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Table 92. Evidence Table: Adverse Effects of Opioid Medications |
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Strong evidence |
Evidence statement |
Design |
|
Adverse events such as constipation, dizziness, and drowsiness are more frequent with opioids than with placebo. |
Systematic review |
|
|
Good evidence |
Evidence statement |
Design |
|
Opioids produce significantly more adverse effects than placebo such as constipation, drowsiness, dizziness, nausea, and vomiting. |
Systematic review |
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Table 93. Evidence Table: Opioid Medications Effectiveness |
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Summary: The majority of patients with musculoskeletal pain, including low back pain, do not experience clinically meaningful pain relief or functional improvement with opioid treatment as compared to placebo. For patients with neuropathic pain, there is no evidence that opioid treatment improves function or quality of life. For neuropathic pain patients, opioid treatment is more likely to result in pain relief as compared to placebo, but there is no evidence that opioids are superior to gabapentin or nortriptyline for this indication. Opioids produce significantly more adverse effects than placebo. |
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|
Strong evidence |
Evidence statement |
Design |
|
In the setting of chronic nonspecific low back pain, the short and intermediate term reduction in pain intensity of opioids, compared with placebo, falls short of a clinically important level of effectiveness for a majority of patients, although some patients may experience a clinically meaningful analgesic benefit. |
Systematic review |
|
|
Good evidence |
Evidence statement |
Design |
|
In patients with chronic low back pain, or chronic pain from osteoarthritis of the hip and knee, opioid therapy does not lead to better pain outcomes in terms of daily functioning or in pain intensity. |
RCT |
|
|
In patients with acute nontraumatic musculoskeletal low back pain who have optimized their use of NSAIDs such as naproxen, the addition of oxycodone 5 mg/acetaminophen 325 mg to be taken as needed adds no significant functional benefit in the short term, but it does increase the frequency of adverse events such as dizziness, drowsiness, and GI side effects. |
RCT |
|
|
Opioids are more efficient than placebo in reducing neuropathic pain by clinically significant amounts during the first 8 weeks of treatment. |
Systematic review |
|
|
Lack of evidence |
Lack of evidence statement |
Design |
|
There is a lack of evidence that opioids improve function and quality of life more effectively than placebo. |
Systematic review |
|
|
Lack of evidence cont. |
There is a lack of evidence that opioids are superior to gabapentin or nortriptyline for pain reduction. |
Systematic review |
|
Table 94. Evidence Table: Pre- and Post-Operative Medication Use |
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Some evidence |
Evidence statement |
Design |
|
In the setting of PLIF surgery, a single saline infusion of 800 mg of ibuprofen one half hour prior to surgery may lead to less pain and morphine use in the immediate postoperative period and may thereby be an option for preoperative care of the surgical patient. |
RCT |
|
|
In the setting of elective open single-lumbar discectomy for herniated discs, where morphine is delivered by patient-controlled anesthesia, a low-dose separate infusion of 0.25 mcg/kg/hour of naloxone in the 24 hours after surgery may reduce morphine consumption and reduce postoperative pain, nausea, and pruritus. |
RCT |
|
|
In the setting of 1-level or 2-level spinal fusion surgery, the administration of pre-emptive analgesia 8 hours preoperatively with acetaminophen, ketorolac, and pregabalin may confer benefits in the 48 hours following the procedure in the form of less pain, better ambulation, and less morphine use. |
RCT |
|
|
The preoperative administration of gabapentin in doses as low as 300 mg may reduce postoperative pain and opioid consumption in the setting of spinal laminectomy and fusion. The incidence of many postoperative complications such as nausea, headache, and dizziness is probably similar for gabapentin and placebo. Gabapentin may increase somnolence but may decrease the incidence of urinary retention pruritus. |
Systematic review |
|
Section 9.g. Tobacco Cessation and Supplements
Introduction. Nicotine replacement therapy is used to relieve nicotine withdrawal symptoms by providing nicotine without the use of tobacco. The mechanism of bupropion in smoking cessation is not entirely understood, but it is believed to act by enhancing central nervous system noradrenergic and dopaminergic release. Varenicline reduces the symptoms of nicotine withdrawal by binding to the receptor that mediates the reinforcing effects of nicotine dependence.
Contraindications / Complications / Side Effects and Adverse Events.
Absolute and Relative Contraindications to Tobacco Cessation Therapies.
* Use nicotine replacement therapy with caution in patients with unstable cardiovascular disease.
* Bupropion is contraindicated in those with seizure disorders.
Side Effects and Adverse Events Related to Tobacco Cessation Therapies.
* Nicotine replacement therapy can cause GI symptoms, headache, and local irritation with topical products.
* Bupropion can cause insomnia, agitation, dry mouth, and headache.
* Varenicline can cause nausea, insomnia, neuropsychiatric disorders, and abnormal dreams.
* Review package insert for supplement contraindications and side effects.
Recommendations.
Core Requirements.
Recommendation 206. Tobacco cessation, including medication and behavioral support, are recommended when tobacco use is expected to negatively impact claim-related medical outcomes. Medications may include nicotine patches, gum, inhaler, lozenges or nasal spray, bupropion, or varenicline (table 95).
Evidence Tables.
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Table 95. Evidence Table: Smoking and Non-Operative Spine Care |
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Some evidence |
Evidence statement |
Design |
|
Patients who smoke respond less favorably to non-operative spine care than nonsmokers, and quitting smoking during treatment results in greater improvement than patients who continue smoking during treatment. |
Cohort study |
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Table 96. Evidence Table: Supplements |
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Good evidence |
Evidence statement |
Design |
|
Glucosamine does not improve pain related disability in those with chronic low back pain and degenerative changes on radiologic studies. Therefore, it is not recommended for chronic lower spinal or non-joint pain. |
RCT |
|
|
Some evidence |
Evidence statement |
Design |
|
In patients with chronic low back pain not associated with nerve root compression or radicular symptoms, treatment with pregnenolone may have a moderate short term benefit in reducing pain of moderate intensity as compared with placebo. No information is available regarding functional benefits. |
RCT |
|
