What treatment options are available for a patient with back pain who cannot take Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and has not found relief with acetaminophen (Tylenol)?

From the Guidelines

For patients with back pain who cannot take NSAIDs and haven't found relief with acetaminophen, the most effective alternative treatment option is physical therapy focusing on core strengthening exercises, stretching, and proper body mechanics, as recommended by the American College of Physicians in 2017 1. This approach is highly effective for long-term management and can be combined with other treatments such as:

• Muscle relaxants like cyclobenzaprine (5-10mg three times daily) or baclofen (5-20mg three times daily) for short-term use (1-2 weeks) to reduce muscle spasms associated with back pain
• Topical treatments like lidocaine patches (5%) applied directly to the painful area for up to 12 hours daily, or capsaicin cream (0.025-0.075%) applied 3-4 times daily for localized relief without systemic side effects
• Heat therapy (20 minutes several times daily) or cold therapy (15-20 minutes every 2-3 hours) to reduce inflammation and muscle tension
• Prescription medications like tramadol (50-100mg every 4-6 hours) for short-term use, while cognitive behavioral therapy can help develop pain coping strategies These approaches work by targeting different pain pathways, and the choice of treatment should be based on the individual patient's needs and preferences, as well as the potential benefits and harms of each option, as outlined in the 2017 guideline 1 and supported by a systematic review of systemic pharmacologic therapies for low back pain 1.

From the FDA Drug Label

Tramadol hydrochloride has been studied in three long-term controlled trials involving a total of 820 patients, with 530 patients receiving tramadol hydrochloride Patients with a variety of chronic painful conditions were studied in double-blind trials of one to three months duration. Average daily doses of approximately 250 mg of tramadol hydrochloride in divided doses were generally comparable to five doses of acetaminophen 300 mg with codeine phosphate 30 mg (TYLENOL with Codeine #3) daily, five doses of aspirin 325 mg with codeine phosphate 30 mg daily, or two to three doses of acetaminophen 500 mg with oxycodone hydrochloride 5 mg (TYLOX® ) daily

The efficacy of cyclobenzaprine hydrochloride tablets 5 mg was demonstrated in two seven-day, double-blind, controlled clinical trials enrolling 1405 patients. One study compared cyclobenzaprine hydrochloride tablets 5 and 10 mg t.i. d. to placebo; and a second study compared cyclobenzaprine hydrochloride tablets 5 and 2.5 mg t.i. d. to placebo. Primary endpoints for both trials were determined by patient-generated data and included global impression of change, medication helpfulness, and relief from starting backache.

Treatment Options for a patient with back pain who cannot take NSAIDs and has not found relief with acetaminophen (Tylenol) may include:

• Tramadol: a pain reliever that can be used to treat moderate to moderately severe pain, as seen in the study 2
• Cyclobenzaprine: a muscle relaxant that can be used to treat muscle spasms and back pain, as demonstrated in the study 3

It is essential to consult a healthcare professional to determine the best course of treatment for the patient's specific condition.

From the Research

Treatment Options for Back Pain

• For patients who cannot take Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and have not found relief with acetaminophen (Tylenol), alternative treatment options are available 4, 5, 6.
• Mild opioids, non-benzodiazepine muscle relaxants, and cyclic antidepressants may be considered as second-line drugs for acute and chronic low back pain 4.
• Tramadol, which works through a combined mechanism of weak mu receptor binding and the inhibition of serotonin and norepinephrine reuptake, is an effective analgesic for chronic pain syndromes and may be an option for patients who cannot take NSAIDs 6.

Pharmacologic Therapy for Acute Pain

• Pharmacologic management of acute pain should be tailored for each patient, including a review of treatment expectations and a plan for the time course of prescriptions 5.
• Adjunctive medications, such as muscle relaxants, may be added as appropriate for specific conditions if the recommended dose and schedule of first-line agents are inadequate 5.
• For severe or refractory acute pain, treatment can be briefly escalated with the use of medications that work on opioid and monoamine receptors, such as tramadol or tapentadol, or with the use of acetaminophen/opioid or NSAID/opioid combinations 5.

Non-Steroidal Anti-Inflammatory Drugs for Low Back Pain

• Non-steroidal anti-inflammatory drugs (NSAIDs) are effective for short-term symptomatic relief in patients with acute low back pain, but there is no evidence that one type of NSAID is more effective than others 7, 8.
• The use of NSAIDs for acute low back pain is associated with a small but significant effect in favor of NSAIDs compared to placebo for short-term pain reduction and global improvement 8.
• However, the magnitude of these effects is small and probably not clinically relevant, and there is very low quality evidence of no clear difference in the proportion of participants experiencing adverse events when using NSAIDs compared to placebo 8.