Dataset Information

Randomised controlled trial evaluating the short-term analgesic effect of topical diclofenac on chronic Achilles tendon pain: a pilot study.

ABSTRACT:

Objectives

To determine if a topically applied non-steroidal anti-inflammatory drug (diclofenac) can provide short-term pain relief for chronic Achilles tendinopathy (CAT), in order to inform the development of a new rehabilitation protocol.

Design and setting

Pilot double-blind, cross-over randomised controlled trial providing participants with tertiary care. The study was conducted at a single research centre in Vancouver, BC.

Participants

Sixteen adults with unilateral CAT and three adults with bilateral CAT participated.

Interventions

Participants received two successive treatments (10% diclofenac gel or placebo gel) in random order over a 3-day period. There was a 1-week washout period between the treatments. Allocation was by simple randomisation, and the participants as well as the assessing/treating researcher were blinded to treatment allocation.

Outcome measures

The primary outcome measure was pain level (0-10) during tendon loading (hopping). Secondary outcome measures included pain at rest, pressure pain threshold of the Achilles tendon and symptom improvement.

Results

Nineteen adults participated in the study, and all were included in the analysis. Diclofenac gel significantly reduced the average pain during tendon loading (p<0.001) and at rest (p=0.031). The average baseline hopping pain was 4.8/10 (95% CI 3.92?to 5.68) and was reduced to 3.1/10 (2.35-3.85) by diclofenac. Pain at rest was decreased and pressure pain threshold increased with diclofenac treatment, but not with placebo gel. There were no observed or reported side effects of either treatment.

Conclusions

In this small, short-term study, diclofenac was able to improve symptoms and reduce pain during tendon loading in participants with CAT, whereas placebo gel was not. A future study of diclofenac as a supplement to rehabilitation, with longer follow-up and powered to detect a difference between diclofenac and placebo, is indicated.

Trial registration

ISRCTN60151284, http://www.isrctn.com/ISRCTN60151284 ETHICS: UBC Clinical Research Ethics Board approval was obtained for this research. The certificate number of the ethics certificate of approval to conduct research is H15-00999.

SUBMITTER: Bussin ER

PROVIDER: S-EPMC5566615 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Randomised controlled trial evaluating the short-term analgesic effect of topical diclofenac on chronic Achilles tendon pain: a pilot study.

Bussin Erin Rebecca ER Cairns Brian B Bovard Jim J Scott Alexander A

BMJ open 20170504 4

<h4>Objectives</h4>To determine if a topically applied non-steroidal anti-inflammatory drug (diclofenac) can provide short-term pain relief for chronic Achilles tendinopathy (CAT), in order to inform the development of a new rehabilitation protocol.<h4>Design and setting</h4>Pilot double-blind, cross-over randomised controlled trial providing participants with tertiary care. The study was conducted at a single research centre in Vancouver, BC.<h4>Participants</h4>Sixteen adults with unilateral C ...[more]

PMID: 28473518

Similar Datasets

Project description:ObjectiveTo determine whether an injection of platelet rich plasma improves outcomes after acute Achilles tendon rupture.DesignRandomised, placebo controlled, two arm, parallel group, participant and assessor masked, superiority trial.SettingSecondary care trauma units across 19 hospitals in the United Kingdom's health service.ParticipantsRecruitment commenced in July 2015 and follow-up was completed in March 2018. 230 adults aged 18 years and over were included, with acute Achilles tendon rupture presenting within 12 days of injury and managed with non-surgical treatment. Exclusions were injury at the insertion or musculotendinous junction, major leg injury or deformity, diabetes mellitus, platelet or haematological disorder, systemic corticosteroids, anticoagulation treatment, and other contraindicating conditions.InterventionsParticipants were randomised 1:1 to platelet rich plasma (n=114) or placebo (dry needle; n=116) injection. All participants received standard rehabilitation care (ankle immobilisation followed by physiotherapy).Main outcomes and measuresPrimary outcome was muscle tendon function at 24 weeks, measured objectively with the limb symmetry index (injured/uninjured×100) in maximal work done during the heel rise endurance test (an instrumented measure of repeated single leg heel rises until fatigue). Secondary outcomes included patient reported function (Achilles tendon rupture score), quality of life (short form 12 version 2®), pain (visual analogue scale), goal attainment (patient specific functional scale), and adverse events. A central laboratory analysed the quality and content of platelet rich plasma. Analyses were by modified intention to treat.ResultsParticipants were 46 years old on average, and 57 (25%) of 230 were female. At 24 weeks, 202 (88%) participants completed the heel rise endurance test and 216 (94%) the patient reported outcomes. The platelet rich plasma was of good quality, with expected growth factor content. No difference was detected in muscle tendon function between participants receiving platelet rich plasma injections and those receiving placebo injections (limb symmetry index, mean 34.7% (standard deviation 17.7%) v 38.5% (22.8%); adjusted mean difference -3.9% (95% confidence interval -10.5% to 2.7%)) or in any secondary outcomes or adverse event rates. Complier average causal effect analyses gave similar findings.ConclusionsThere is no evidence to indicate that injections of platelet rich plasma can improve objective muscle tendon function, patient reported function, or quality of life after acute Achilles tendon rupture compared with placebo, or that they offer any patient benefit.Trial registrationISRCTN54992179.

Dataset Information

Randomised controlled trial evaluating the short-term analgesic effect of topical diclofenac on chronic Achilles tendon pain: a pilot study.

Objectives

Design and setting

Participants

Interventions

Outcome measures

Results

Conclusions

Trial registration

Publications

Randomised controlled trial evaluating the short-term analgesic effect of topical diclofenac on chronic Achilles tendon pain: a pilot study.

Similar Datasets

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