Summary
Diazepam 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 3 registered trials linking Diazepam to Low Back Pain: 3 have completed. The most advanced is PHASE2, PHASE3 (NCT02646124). It plans or enrolled 114 participants. Registration activity spans 2013 to 2016. The literature layer holds 4 publications for this pair: 1 Cochrane review and 3 clinical trial publications. Publication years run from 1998 to 2026. 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 | 38.5 (trials 7.5, literature 11.0, tier 15, approved bonus 5.0) |
| Registered trials | 3 total: 0 recruiting, 0 active / not yet recruiting, 3 completed, 0 other |
| Linked publications | 4 (3 clinical trial publications, 1 Cochrane review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | ADORA1 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT02707094 | A Pilot Study Examining the Efficacy of Biomodulator Treatment for Chronic Low Back Pain 2013 | completed | Not applicable | 75 |
| NCT02646124 | Diazepam Use With Standard Management for Acute Low Back Pain 2015 | completed | PHASE2, PHASE3 | 114 |
| NCT03996564 | Battlefield Acupuncture for Acute/Subacute Back Pain in the Emergency Department 2016 | completed | Not applicable | 26 |
Published literature
- Cochrane review [Systematic review of the literature and evaluation of the effectiveness of muscle relaxants in acute low back pain according to REB method]Langelier H, Pires J, Boussageon R · Therapie · 2026 · PMID 42067418
- Clinical trial publication Methocarbamol versus diazepam in acute low back pain in the emergency department: a randomised double-blind clinical trialSharifi M, Abdorazzaghnejad A, Yazdchi M et al. · Emergency medicine journal : EMJ · 2023 · PMID 37068928
- Clinical trial publication Diazepam Is No Better Than Placebo When Added to Naproxen for Acute Low Back PainFriedman BW, Irizarry E, Solorzano C et al. · Annals of emergency medicine · 2017 · PMID 28187918
- Clinical trial publication Postdural puncture headache and transient neurologic symptoms in children after spinal anaesthesia using cutting and pencil point paediatric spinal needlesKokki H, Hendolin H, Turunen M · Acta anaesthesiologica Scandinavica · 1998 · PMID 9809091
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 Open Targets and ChEMBL, in this case via the biomarker or target ADORA1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Diazepam approved for Low Back Pain?
Diazepam 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 Diazepam in clinical trials for Low Back Pain?
ClinicalTrials.gov lists 3 registered trials linking Diazepam to Low Back Pain: 3 have completed. The most advanced is PHASE2, PHASE3 (NCT02646124). It plans or enrolled 114 participants. Registration activity spans 2013 to 2016.
What does the evidence show for Diazepam in Low Back Pain?
Diazepam 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 Open Targets and ChEMBL, in this case via the biomarker or target ADORA1. 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.