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Diclofenac for Achilles tendinopathy

Randomized controlled trial to evaluate the effects of topical diclofenac on the pain associated with chronic achilles tendinopathy: a pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN60151284
Enrollment
32
Registered
2015-07-03
Start date
2015-07-27
Completion date
Unknown
Last updated
2017-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achilles tendinopathy Musculoskeletal Diseases

Interventions

This study has a crossover design. All 32 participants will be receiving the treatment and the placebo. This study is double-blinded. Whether or not participants receive the drug treatment for visit 2

Sponsors

University of British Columbia
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male and female subjects aged 19 years and older 2. Fluent in English 3. Subjects previously diagnosed with Achilles tendinopathy by a health care professional and demonstrating the following criteria – localized tendon pain and thickening, worsened with palpation and tendon loading activities, and no clinical suspicion of other diagnoses 4. Symptoms for 3 months or more 5. Subjects who are able to give informed consent 6. VISA-A score less than 80 7. Pain score (numeric pain rating scale) greater than 2/10 when performing a hopping test (25 single leg hops on the painful side)

Exclusion criteria

Exclusion criteria: 1. Male and female subjects aged 18 years and younger 2. Subjects with a BMI greater than 30.0 3. Subjects with previous Achilles tendon rupture 4. Subjects diagnosed with pain syndrome, diabetes, hyperproteinemia, metabolic syndrome, or systemic inflammatory diseases 5. Subjects with symptomatic osteoarthritis of the spine or lower extremities 6. Subjects who have received corticosteroid injections 7. Subjects who take non-steroidal anti-inflammatory medication regularly 8. Subjects who have been prescribed statins, anticoagulant, or fluroquinolones within the past 3 months 9. Subjects with allergies to diclofenac or placebo cream 10. Subjects who are unable to give informed consent

Design outcomes

Primary

MeasureTime frame
Measured at baseline, 1 week, day 10, and day 23 Assessment of tendon pain while performing 25 single-leg hops on the painful side, rated verbally using the numeric pain rating scale. The hopping test consists of 25 rhythmic hops, at a self-selected/comfortable pace (approx. 2 jumps/second), on one leg, first on the unaffected side, and then on the affected side (15 second rest between each leg). ). At the end of the hopping, the subject’s pain level will be recorded using a pain numeric rating scale (0-10).

Secondary

MeasureTime frame
Measured at baseline, 1 week, day 10, and day 23 1. Assessment of pressure pain threshold (PPT) using an Algometer, on the Achilles tendon, and at an unrelated location (the trapezius muscle) to examine for potential effects of the treatment on central pain processing.). The investigator will use the AlgoMed Algometer to assess the subject’s pain pressure threshold (PPT) on the trapezius muscle (bilaterally) and on both Achilles tendons. Testing will be conducted at a controlled rate (30 KPa/s) with the subject lying prone on a treatment plinth. Pressure is gradually applied until the subject first experiences onset of pain, at which point they push a button. In rare cases where the person with CAT has baseline (resting) pain, then they will be instructed to press the button at the first increase in pain. 2. Assessment of lower limb kinematics during single-leg multiple hops using the LEONARDO Mechanography Ground Reaction Force Platform (GRFP) to determine the maximum force generated (normalized to body mass of participant) and leg stiffness.

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 27, 2026