A Prospective Randomized Study Comparing the Therapeutic Effect of Tendoactive®, Eccentric Training, and a Combination of Both as a Treatment of Achilles Tendinopathy
Overview
- Phase
- Not Applicable
- Intervention
- Tendoactive
- Conditions
- Achilles Tendinopathy
- Sponsor
- Bioiberica
- Enrollment
- 100
- Locations
- 6
- Primary Endpoint
- Change from Baseline in VISA-A score at 12 weeks
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to determine whether Tendoactive, eccentric training, or the combination or both could be effective in the treatment of Achilles tendinopathy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients suffering from a gradually evolving painful condition in the Achilles tendon located at the midportion for at least 3 months (Diagnosis based on clinical examination showing a painful thickening of the Achilles tendon located at a level of 2 to 6cm above the tendon insertion, and confirmed by ultrasonography: local thickening of the tendon, irregular tendon structure with hypoechoic areas and irregular fiber orientation).
- •Men and non-pregnant women aged 18-70 years
- •Be informed of the nature of the study and provide written informed consent.
Exclusion Criteria
- •Clinical suspicion of insertional disorders (pain at the site of the insertion of the Achilles tendon on the calcaneum)
- •Clinical suspicion of an Achilles tendon rupture (Thompson test abnormal and palpable "gap")
- •Clinical suspicion of plantar flexor tenosynovitis (posteromedial pain when the toes are plantar flexed against resistance)
- •Clinical suspicion of n.suralis pathology (sensitive disorder in the area of the sural nerve)
- •Clinical suspicion of peroneal subluxation
- •Suspicion of internal disorders: spondylarthropathy, gout, hyperlipidemia, Rheumatoid Arthritis and sarcoidosis.
- •Condition that prevents the patients from executing an active exercise programme
- •Patient has already performed eccentric exercises, according to the schedule of Alfredson et al (12 weeks)
- •Patient has already received an injection of PRP for this injury
- •Patient does not wish, for whatever reason, to undergo one of the two treatments
Arms & Interventions
Tendoactive and eccentric training
Tendoactive dosage: 3 capsules per day. Eccentric training: protocol described by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)
Intervention: Tendoactive
Tendoactive and eccentric training
Tendoactive dosage: 3 capsules per day. Eccentric training: protocol described by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)
Intervention: Eccentric training
Tendoactive
Tendoactive dosage: 3 capsules per day
Intervention: Tendoactive
Eccentric training
Protocol published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)
Intervention: Eccentric training
Outcomes
Primary Outcomes
Change from Baseline in VISA-A score at 12 weeks
Time Frame: 12 weeks
Functional impairment of the Achilles tendon is measured using VISA-A score. Score of patient-related outcome measure: Achilles tendon: VISA-A \[0=worse, 100=perfect\] derived from eight validated questions on pain and function during activities of daily living
Secondary Outcomes
- Pain level at rest [VAS 0-10](0, 6, 12 weeks)
- Pain level at exertion [VAS 0-10](0, 6, 12weeks)
- Achilles transverse thickness by ultrasound(0, 6, 12 weeks)
- SF-36 v2 quality of life survey(0, 12 weeks)
- Patient satisfaction(6, 12 weeks)