Capsaicin + Diclofenac Gel in Acute Back Pain or Neck Pain

Summary

This randomised, controlled multi-centre parallel group trial will assess the efficacy and tolerability of a topical formulation gel of the combination of diclofenac and capsaicin in comparison to gels with diclofenac alone, capsaicin alone, and placebo for the treatment of acute back pain or neck pain

Timeline

Start

2016-05-09

Primary completion

2017-07-13

Completion

2017-07-21

Outcome

Met primary endpoint

registry Placebo Gel vs Diclofenac (2%) +Capsaicin (0.075%) Gel; p = 0.0303; Mean Difference (Net) -0.60 (95% CI -1.15 to -0.06) NCT02700815 ↗

paper demonstrates superiority of the combination (- 3.05 cm) versus diclofenac alone (- 2.33 cm) and placebo (- 2.45 cm). PMID 32221866 ↗

Publications

• Predel HG, Ebel-Bitoun C, Peil B, Weiser TW, Lange R. Efficacy and Safety of Diclofenac + Capsaicin Gel in Patients with Acute Back/Neck Pain: A Multicenter Randomized Controlled Study. Pain Ther. 2020 Jun;9(1):279-296. doi: 10.1007/s40122-020-00161-9. Epub 2020 Mar 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capsaicin	Small molecule	0.075 %	Topical
Subject	Diclofenac	Other / unclassified	2 %	Topical

Indications

No indication recorded.