Summary
Cyclobenzaprine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Low Back Pain would be drug repurposing rather than first-in-human development. This does not mean it is approved for Low Back Pain. ClinicalTrials.gov lists 7 registered trials linking Cyclobenzaprine to Low Back Pain: 1 is currently recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01587274). It plans or enrolled 323 participants. Registration activity spans 2007 to 2020. The literature layer holds 10 publications for this pair: 3 Cochrane reviews, 1 meta-analysis, 1 systematic review and 5 clinical trial publications. Publication years run from 2003 to 2024. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Low Back Pain ranks 331 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: ~90% of acute LBP episodes resolve within 6 weeks regardless of treatment; chronic LBP (>3 months) shows only 30-40% recovery at 1 year and high recurrence; opioid prescribing correlates inversely with recovery.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 74.5 (trials 24.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 7 total: 1 recruiting, 0 active / not yet recruiting, 4 completed, 2 other |
| Linked publications | 10 (5 clinical trial publications, 3 Cochrane reviews, 1 meta-analysis, 1 systematic review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | ADRA2C |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT01587274 | A Randomized Study of Three Medication Regimens for Acute Low Back Pain 2012 | completed | Phase 4 | 323 |
| NCT04704297 | Trigger Point Injection for Myofascial Pain Syndrome in the Low Back: A Randomized Controlled Trial 2020 | recruiting | Phase 4 | 180 |
| NCT02814565 | Cyclobenzaprine HCl Extended Release 15 mg Versus Placebo in Treatment of Cervical and/or Lower Back Pain Due to Muscle Spasms of Local Origin 2016 | completed | Phase 3 | 180 |
| NCT01421433 | A Comparative Study Between Lysine Clonixinate+Cyclobenzaprine and Caffeine+Carisoprodol+Sodium Diclofenac+Paracetamol 2012 | status unknown | Phase 3 | 160 |
| NCT01587508 | Study Comparing A New Drug Containing The Combination Meloxicam And Cyclobenzaprine In The Treatment Of Acute Lumbago 2013 | withdrawn | Phase 3 | — |
| NCT02707094 | A Pilot Study Examining the Efficacy of Biomodulator Treatment for Chronic Low Back Pain 2013 | completed | Not applicable | 75 |
| NCT00386243 | Evaluation of Stepped Care for Chronic Pain in Iraq/Afghanistan Veterans (ESCAPE) 2007 | completed | Not applicable | 242 |
Published literature
- Cochrane review Long-Term Use of Muscle Relaxant Medications for Chronic Pain: A Systematic ReviewOldfield BJ, Gleeson B, Morford KL et al. · JAMA network open · 2024 · PMID 39298168
- Clinical trial publication An assessment of the centrally acting muscle relaxant tolperisone on driving ability and cognitive effects compared to placebo and cyclobenzaprineCaron J, Kaye R, Wessel T et al. · Journal of clinical pharmacy and therapeutics · 2020 · PMID 32390248
- Cochrane review PubMed record PMID 32338847McDonagh MS, Selph SS, Buckley DI et al. · 2020
- Clinical trial publication Comparison of naproxen with cyclobenzaprine, oxycodone-acetaminophen, and placebo for the treatment of acute low back painGottlieb M, Njie A · CJEM · 2016 · PMID 27640607
- Systematic review 2016 Update on Medical Overuse: A Systematic ReviewMorgan DJ, Dhruva SS, Wright SM et al. · JAMA internal medicine · 2016 · PMID 27654002
- Clinical trial publication Naproxen With Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back Pain: A Randomized Clinical TrialFriedman BW, Dym AA, Davitt M et al. · JAMA · 2015 · PMID 26501533
- Clinical trial publication Efficacy and tolerability of cyclobenzaprine extended release for acute muscle spasm: a pooled analysisWeil AJ, Ruoff GE, Nalamachu S et al. · Postgraduate medicine · 2010 · PMID 20675978
- Meta-analysis Pharmacotherapy of chronic pain: a synthesis of recommendations from systematic reviewsKroenke K, Krebs EE, Bair MJ · General hospital psychiatry · 2009 · PMID 19410099
- Cochrane review Commonly used muscle relaxant therapies for acute low back pain: a review of carisoprodol, cyclobenzaprine hydrochloride, and metaxaloneToth PP, Urtis J · Clinical therapeutics · 2004 · PMID 15530999
- Clinical trial publication Efficacy of a low-dose regimen of cyclobenzaprine hydrochloride in acute skeletal muscle spasm: results of two placebo-controlled trialsBorenstein DG, Korn S · Clinical therapeutics · 2003 · PMID 12809957
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ADRA2C. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Cyclobenzaprine approved for Low Back Pain?
Cyclobenzaprine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Low Back Pain would be drug repurposing rather than first-in-human development. This does not mean it is approved for Low Back Pain. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Cyclobenzaprine in clinical trials for Low Back Pain?
ClinicalTrials.gov lists 7 registered trials linking Cyclobenzaprine to Low Back Pain: 1 is currently recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01587274). It plans or enrolled 323 participants. Registration activity spans 2007 to 2020.
What does the evidence show for Cyclobenzaprine in Low Back Pain?
Cyclobenzaprine has both completed registered trials and synthesis-level publications linked to Low Back Pain. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ADRA2C. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.