Indomethacin 25mg BID for 90 Days in Low Back Pain: Not Recommended
No, you should not add indomethacin 25mg BID for 90 days to this patient for low back pain. While NSAIDs including indomethacin have evidence for short-term efficacy in low back pain, the proposed 90-day duration is excessive, unsupported by evidence, and carries substantial cardiovascular, gastrointestinal, and renal risks that outweigh potential benefits 1.
Why This Regimen Is Inappropriate
Duration Concerns
- The American College of Physicians explicitly states that "extended courses of medications should generally be reserved for patients clearly showing continued benefits from therapy without major adverse events," and evidence for long-term NSAID use in low back pain is insufficient 1.
- The FDA-approved dosing for indomethacin states "use the lowest effective dose for the shortest duration consistent with individual patient treatment goals," with typical courses for musculoskeletal conditions lasting 7-14 days, not 90 days 2.
- Clinical trials demonstrating NSAID efficacy in chronic low back pain had median follow-up of only 56 days (IQR 13-91 days), and the small effect size (mean difference -3.30 on 0-100 VAS) does not justify prolonged exposure 3.
Safety Profile
- NSAIDs carry well-documented gastrointestinal and renovascular risks, plus associations with increased myocardial infarction risk with both COX-2 selective and most non-selective NSAIDs 1.
- Indomethacin specifically has higher rates of adverse events compared to other treatment options—in gout trials, 63% of indomethacin-treated patients reported adverse events versus 27% with corticosteroids, with gastrointestinal events being particularly common 1.
- A 90-day course dramatically increases cumulative risk exposure without proportional benefit, as the magnitude of NSAID effect on chronic low back pain is small (mean disability improvement of only -0.85 on 0-24 Roland Morris scale) 3.
What You Should Do Instead
First-Line Approach for Acute Low Back Pain (<4 weeks)
- Start with acetaminophen as first-line due to more favorable safety profile and low cost, despite being slightly weaker analgesic than NSAIDs (<10 points difference on 100-point VAS) 1.
- If acetaminophen is insufficient, use a short course (7-14 days maximum) of an NSAID at the lowest effective dose, with careful assessment of cardiovascular and gastrointestinal risk factors before prescribing 1, 2.
- For indomethacin specifically, if chosen, the FDA-approved regimen for acute musculoskeletal conditions is 75-150mg daily in 3-4 divided doses for 7-14 days until inflammation is controlled 2.
For Chronic or Subacute Low Back Pain (>4 weeks)
- Prioritize non-pharmacologic therapies with proven benefits: exercise therapy, spinal manipulation, acupuncture, massage therapy, yoga, or cognitive-behavioral therapy 1.
- If pharmacologic treatment is needed beyond initial short-term NSAID use, consider duloxetine 30-60mg daily, which has moderate-quality evidence for chronic low back pain and targets both neuropathic and inflammatory components 4, 5.
- For patients with radiculopathy component, gabapentin 1200-3600mg/day in divided doses has small to moderate benefits 1, 5.
If Short-Term NSAID Use Is Necessary
- Use the lowest effective dose for the shortest duration (typically ≤2 weeks) 4.
- Strongly prefer topical NSAIDs (diclofenac gel) over oral formulations if pain is localized, as they are safer 4.
- Co-prescribe a proton pump inhibitor if oral NSAIDs are necessary to reduce gastrointestinal complications 4.
- Monitor renal function 1-2 weeks after starting NSAIDs, especially in older adults or those with baseline renal impairment 4.
Critical Pitfalls to Avoid
- Do not prescribe NSAIDs for extended periods without clear evidence of ongoing benefit and absence of adverse effects—reassess at 2-4 weeks maximum 1.
- Do not use indomethacin as a first-choice NSAID for low back pain, as it has higher adverse event rates compared to other NSAIDs like ibuprofen or naproxen 1.
- Do not ignore the need for non-pharmacologic interventions, which have moderate effectiveness and should be the foundation of chronic low back pain management 1.
- Avoid the temptation to continue ineffective medications—if no meaningful improvement occurs after a time-limited trial, reassess and consider alternative therapies or referral 1, 5.