Naproxen Alone May Be Best for Acute Low Back Pain

The number needed to harm (NNH) is presented with a 95% CI when naproxen + active medication resulted in a statistically significant increase in adverse events compared with naproxen + placebo. Friedman et al. conducted a well-designed, randomized controlled study comparing the combination of naproxen with oxycodone/acetaminophen, cyclobenzaprine, or placebo assessing improvement in functional outcomes using a previously validated scoring tool. There was unclear risk of bias with regard to outcome assessment, as the authors do not state whether the research assistants performing follow-up phone calls were blinded to the treatment allocations. This approach may lead to uncertainty with regard to interpretation of the data when some of the outcomes result in a statistically significant benefit and others do not. In this study, we saw no difference in outcomes between those randomized to receive naproxen + placebo vs those randomized to receive naproxen + oxycodone/acetaminophen. However, among patients who used the investigational medication more than once, fewer patients who used oxycodone/acetaminophen reported moderate or severe pain.

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The activity of Flexeril that depresses the Central Nervous System (CNS) makes it potentially addictive and dangerous. The most common adverse reactions to cyclobenzaprine are somnolence, dry mucous membranes, dizziness, and confusion. Less commonly, tachycardia, dysarthria, disorientation, and hallucinations have been reported [2].

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These latter findings must be interpreted cautiously because of the large number of analyses we performed. Our results are consistent with other reports of outcomes after acute-onset LBP.29-34 In general, most patients with acute-onset LBP report persistent symptoms 1 week later. Risk factors for poor long-term LBP outcomes consist of complicated LBP histories and radicular symptoms.35 In our study, we selected patients at low risk of poor outcome by excluding those with chronic LBP, radicular symptoms, or chronic use of opioids. Despite selecting for these low-risk patients, more than 20% of our cohort, regardless of study group, reported poor outcomes at 3 months after the ED visit. Flexeril is a medication belonging to a class of skeletal muscle relaxants used to treat muscle spasms.

Among the patients who used the cyclobenzaprine, oxycodone/acetaminophen, or placebo investigational medication more than once, there was no significant difference in the primary outcome (eTable 1 in Supplement 2). Patients randomized to oxycodone/acetaminophen were more likely than those randomized to placebo to report pain levels of mild or none (difference, 18% [95% CI, 3% to 33%]; number needed to treat, 6 [95% CI, 3 to 37]). This study sought to determine the benefit of treating acute LBP with cyclobenzaprine or oxycodone/acetaminophen in combination with an NSAID compared to treatment with an NSAID alone. Cyclobenzaprine labeling suggests that concomitant use with tramadol may place patients at higher risk for developing seizures.19 Attendant use of cyclobenzaprine with monoamine oxidase inhibitors or use within 14 days after their discontinuation is contraindicated.

Other than the adverse effects listed in Table 4, none occurred in more than 3 participants in any study group. The medicine treats the condition by providing is flexeril considered a controlled substance intermittent relief to the pain caused due to the spasms. It blocks the pathway of neurotransmitters that are responsible for the sensation of pain.

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Interventions  All participants were given 20 tablets of naproxen, 500 mg, to be taken twice a day. They were randomized to receive either 60 tablets of placebo; cyclobenzaprine, 5 mg; or oxycodone, 5 mg/acetaminophen, 325 mg. Participants were instructed to take 1 or 2 of these tablets every 8 hours, as needed for LBP. They also received a standardized 10-minute LBP educational session prior to discharge. Adding cyclobenzaprine or oxycodone/acetaminophen to naproxen for the treatment of acute low back pain does nothing more than increase adverse effects.

• Some mixtures of medications can lead to serious and even fatal consequences.
• Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there.
• Our results are consistent with other reports of outcomes after acute-onset LBP.29-34 In general, most patients with acute-onset LBP report persistent symptoms 1 week later.
• Consider treating patients with acute low back pain with naproxen only, as adding cyclobenzaprine or oxycodone/acetaminophen to scheduled naproxen does not improve functional assessment at 7 days or 3 months and increases adverse effects.

In these patients, encouraging activity and ensuring primary care follow-up may be the most important ED interventionsReference Hagen, Jamtvedt and Hilde 10 . Our results are similar to other studies of NSAIDs combined with cyclobenzaprine8,10,11,18 conducted in a variety of settings, including an ED and primary care and specialty clinics. Despite the fact that both NSAIDS and cyclobenzaprine are efficacious when administered as monotherapy,5,19 the bulk of the data, including the findings in this study, suggest combination therapy is not better than monotherapy.

This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Data sources include IBM Watson Micromedex (updated 3 Sep 2023), Cerner Multum™ (updated 28 Aug 2023), ASHP (updated 10 Aug 2023) and others. Since Flexeril is a muscle relaxant that shows the depressive activity of the CNS, it is not recommended to drive or do any dangerous activity under the influence of Flexeril. Combining this drug with alcohol may worsen the side effects you may observe. Modifying the drug dose without consulting a physician to amplify its impact is also not recommended. The dosage is based on your medical condition and response to treatment.

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve mild to moderate pain, inflammation, and fever. Other NSAIDs include ibuprofen (Motrin), indomethacin (Indocin), nabumetone (Relafen), and several others. These drugs work by reducing the levels of prostaglandins, chemicals that are responsible for pain, fever, and inflammation. Naproxen blocks the enzyme that makes prostaglandins (cyclooxygenase), resulting in lower concentrations of prostaglandins, and thereby reducing inflammation, pain, and fever. Add your drug list to My Med List to view medical information in a simple, easy-to-read, personalized format.

Do not take more of it and do not take it more often than your doctor ordered. Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.