Diclofenac for Achilles tendinopathy

• Register: ISRCTN
• Last refreshed on: 5 June 2017
• Main ID: ISRCTN60151284
• Date of registration: 03/07/2015
• Prospective Registration: Yes
• Primary sponsor: University of British Columbia
• Public title: Diclofenac for Achilles tendinopathy
• Scientific title: Randomized controlled trial to evaluate the effects of topical diclofenac on the pain associated with chronic achilles tendinopathy: a pilot study
• Date of first enrolment: 27/07/2015
• Target sample size: 32
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN60151284
• Study type: Interventional
• Study design: Single-centre pilot crossover randomized controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Canada

Contacts

• Name: Erin Bussin

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Achilles tendinopathy
Musculoskeletal Diseases

Intervention(s)

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 or visit 3 will be determined by chance (e.g. coin flip). The dosage in this study is 80 mg of diclofenac (1 gm of 10% diclofenac) three times a day (every 8 hours) for 3 days. There is no follow-up.

Primary Outcome(s)

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 Outcome(s)

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.

Secondary ID(s)

N/A

Source(s) of Monetary Support

University of British Columbia