Topical Capsaicin 0.025% as a treatment for Achilles tendinopathy. A prospective, double blinded, randomised controlled trial with multiple outcome measures.

Phase 1

• Conditions: Achilles Tendinopathy

• Registration Number: EUCTR2006-005471-18-GB
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-20
• Study Completion: 2009-09-10
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Aged 18 - 65 years of age to ensure skeletal maturity, and try to exclude
degenerative changes seen in the elderly.
2. Patients able to give informed consent.
3. Confirmed diagnosis of Achilles tendinopathy (tendinosis) of greater than 3
months duration - implying treatment is required as the condition is unlikely to
resolve spontaneously.
4. Do not have any contraindications to the topical cream (e.g. allergies).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Systemic inflammatory condition (e.g. rheumatoid arthritis) as a cause of the
condition – i.e. requires additional treatment.
2. Pre-existing concurrent pathology or deformity that may be the cause of pain or
functional deficits.
3. Previous history of surgery to the ankle / lower limb, specifically the Achilles
tendon.
4. Any women who are or could possibly be pregnant.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the efficacy of topically applied Capsaicin 0.025% combined with eccentric loading as a treatment for chronic Achilles tendinopathy.;Secondary Objective: ;Primary end point(s): The end of the trial will occur upon the final scheduled visit of the final patient to undertake the treatment. All treatment with the active and placebo creams will be ceased at 6 weeks from the patients start date.