The Efficacy of Tendoactive, Eccentric Training, and the Combination of Both as a Treatment of Achilles Tendinopathy
This study is currently recruiting participants.
Verified September 2012 by Bioiberica
Sponsor:
Bioiberica
Information provided by (Responsible Party):
Bioiberica
ClinicalTrials.gov Identifier:
NCT01691716
First received: September 13, 2012
Last updated: September 21, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Achilles Tendinopathy |
Drug: Tendoactive Behavioral: Eccentric training |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective Randomized Study Comparing the Therapeutic Effect of Tendoactive®, Eccentric Training, and a Combination of Both as a Treatment of Achilles Tendinopathy |
Resource links provided by NLM:
Further study details as provided by Bioiberica:
Primary Outcome Measures:
- Change from Baseline in VISA-A score at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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 Outcome Measures:
- Pain level at rest [VAS 0-10] [ Time Frame: 0, 6, 12 weeks ] [ Designated as safety issue: No ]
- Pain level at exertion [VAS 0-10] [ Time Frame: 0, 6, 12weeks ] [ Designated as safety issue: No ]
- Achilles transverse thickness by ultrasound [ Time Frame: 0, 6, 12 weeks ] [ Designated as safety issue: No ]Ultrasound evaluation of Achilles tendon. Maximum thickness will be recorded in the midportion of the affected Achilles tendon
- SF-36 v2 quality of life survey [ Time Frame: 0, 12 weeks ] [ Designated as safety issue: No ]
- Patient satisfaction [ Time Frame: 6, 12 weeks ] [ Designated as safety issue: No ]Patient satisfaction will be evaluated using a subjective questionnaire.
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2012 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tendoactive
Tendoactive dosage: 3 capsules per day
|
Drug: Tendoactive
Food supplement containing mucopolysaccharides, type I collagen and vitamin C
|
|
Active Comparator: Eccentric training
Protocol published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)
|
Behavioral: Eccentric training
Eccentric training program published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)
|
|
Active Comparator: 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)
|
Drug: Tendoactive
Food supplement containing mucopolysaccharides, type I collagen and vitamin C
Behavioral: Eccentric training
Eccentric training program published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- Known presence of a pregnancy
- Condition of the Achilles tendon caused by medications (arising in relation to moment of intake), such as quinolones and statins
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01691716
Contacts
| Contact: Ramon Balius, MD | +34 93 4804900 | rbalius@gencat.cat |
Locations
| Spain | |
| CEARE | Recruiting |
| Esplugues de Llobregat, Barcelona, Spain, 08950 | |
| Principal Investigator: Ramon Balius, MD | |
| CMI | Recruiting |
| Barcelona, Spain | |
| Sub-Investigator: Carles Pedret, MD | |
| Clínica CEMTRO | Not yet recruiting |
| Madrid, Spain | |
| Sub-Investigator: Fernández Jaen Tomás, MD | |
| AMS - Centro de Ejercicio | Recruiting |
| Malaga, Spain | |
| Sub-Investigator: Alvarez Guillermo, MD | |
| Centro de Medicina y Deporte | Recruiting |
| Toledo, Spain | |
| Sub-Investigator: Fernando Jiménez, MD | |
| Clínica Traumatológica | Recruiting |
| Valladolid, Spain | |
| Sub-Investigator: Fernando Baró, MD | |
Sponsors and Collaborators
Bioiberica
More Information
Publications:
| Responsible Party: | Bioiberica |
| ClinicalTrials.gov Identifier: | NCT01691716 History of Changes |
| Other Study ID Numbers: | PRJ-00014 |
| Study First Received: | September 13, 2012 |
| Last Updated: | September 21, 2012 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by Bioiberica:
|
Achilles tendinopathy Tendoactive Eccentric training |
Additional relevant MeSH terms:
|
Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendon Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013