Topical diclofenac vs placebo for the treatment of chronic Achilles tendinopathy: A randomized controlled clinical trial

PLoS One. 2021 Mar 4;16(3):e0247663. doi: 10.1371/journal.pone.0247663. eCollection 2021.

Abstract

Introduction: The application of topical diclofenac has been suggested as a possible treatment for Achilles tendinopathy. Our aim was to answer the question, is topical diclofenac more effective than placebo for the treatment of Achilles tendinopathy?.

Methods: 67 participants with persistent midportion or insertional Achilles tendinopathy were randomly assigned to receive a 4 week course of 10% topical diclofenac (n = 32) or placebo (n = 35). The a priori primary outcome measure was change in severity of Achilles tendinopathy (VISA-A score) at 4 and 12 weeks. Secondary outcome measures included numeric pain rating, and patient-reported change in symptoms using a 7 point scale, from substantially worse to substantially better. Pressure pain threshold (N) and transverse tendon stiffness (N/m) were measured over the site of maximum Achilles tendon pathology at baseline and 4 weeks.

Results: There were no statistically or clinically significant differences between the diclofenac and placebo groups in any of the primary or secondary outcome measures at any timepoint. Average VISA-A score improved in both groups (p<0.0001), but the improvements were marginal: at 4 weeks, the improvements in VISA-A were 9 (SD 11) in the diclofenac group and 8 (SD 12) in the placebo group, and at 12 weeks the improvements were 9 (SD 16) and 11 (SD13) respectively-these average changes are smaller than the minimum clinically important difference of the VISA-A.

Conclusion: The regular application of topical diclofenac for Achilles tendinopathy over a 4 week period was not associated with superior clinical outcomes to that achieved with placebo.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Topical
  • Adult
  • Analysis of Variance
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use
  • Chronic Disease
  • Dermatitis, Contact / etiology
  • Diclofenac / administration & dosage
  • Diclofenac / adverse effects
  • Diclofenac / therapeutic use*
  • Double-Blind Method
  • Humans
  • Male
  • Middle Aged
  • Outcome Assessment, Health Care / methods
  • Outcome Assessment, Health Care / statistics & numerical data
  • Pain / chemically induced
  • Tendinopathy / drug therapy*
  • Tendinopathy / pathology

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Diclofenac

Grants and funding

Scott F. Nadler PASSOR Musculoskeletal Research Grant - AS, MF, BC, JB (acknowledgements) http://foundationforpmr.org/research-grants-2/scott-f-nadler-passor-musculoskeletal-research-grant/ The funders played no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.