Achilles TendinopathyTendoactiveNCT01691716
The Efficacy of Tendoactive, Eccentric Training, and the Combination of Both as a Treatment of Achilles Tendinopathy
A study testing Tendoactive and Eccentric training in people with Achilles Tendinopathy, run by Bioiberica at 6 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Achilles Tendinopathy
- What is being tested?
- Tendoactive and Eccentric training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesSpain
- Study dates
- Apr 2012to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
CMI
Barcelona, Barcelona
CEARE
Esplugues de Llobregat, Barcelona, 08950
Clínica CEMTRO
Madrid, Madrid
AMS - Centro de Ejercicio
Málaga, Malaga
Centro de Medicina y Deporte
Toledo, Toledo
Clínica Traumatológica
Valladolid, Valladolid
About this study
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
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.
- Conditions
- Achilles Tendinopathy
- Being tested
- Tendoactive, Eccentric training
- Keywords
- Achilles tendinopathy, Tendoactive, Eccentric training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TendoactiveDrug
Food supplement containing mucopolysaccharides, type I collagen and vitamin C
Eccentric trainingBehavioural
Eccentric training program published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)
| Study group | Role | What they receive |
|---|---|---|
| Tendoactive | Experimental | Tendoactive dosage: 3 capsules per day Receives: Drug: Tendoactive |
| Eccentric training | Active comparator | Protocol published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360) Receives: Behavioral: Eccentric training |
| Tendoactive and eccentric training | Active comparator | Tendoactive dosage: 3 capsules per day. Eccentric training: protocol described by Alfredson et al 1998 (Am J Sports Med 1998 26: 360) Receives: Drug: Tendoactive; Behavioral: Eccentric training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in VISA-A score at 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
Measured: 12 weeks
Secondary outcomes (5)
Pain level at rest [VAS 0-10]
Measured: 0, 6, 12 weeks
Pain level at exertion [VAS 0-10]
Measured: 0, 6, 12weeks
Achilles transverse thickness by ultrasound
Ultrasound evaluation of Achilles tendon. Maximum thickness will be recorded in the midportion of the affected Achilles tendon
Measured: 0, 6, 12 weeks
SF-36 v2 quality of life survey
Measured: 0, 12 weeks
Patient satisfaction
Patient satisfaction will be evaluated using a subjective questionnaire.
Measured: 6, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Achilles TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioiberica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691716
- Sponsor's protocol ID
- PRJ-00014
- Acronym
- Tendoactive
- Status last verified
- Feb 2014
- First submitted
- 13 Sep 2012
- Last updated
- 26 Feb 2014
- Results posted
- No
Publications
Alfredson H, Pietila T, Jonsson P, Lorentzon R. Heavy-load eccentric calf muscle training for the treatment of chronic Achilles tendinosis. Am J Sports Med. 1998 May-Jun;26(3):360-6. doi: 10.1177/03635465980260030301.
PubMed 9617396Balius R, Alvarez G, Baro F, Jimenez F, Pedret C, Costa E, Martinez-Puig D. A 3-Arm Randomized Trial for Achilles Tendinopathy: Eccentric Training, Eccentric Training Plus a Dietary Supplement Containing Mucopolysaccharides, or Passive Stretching Plus a Dietary Supplement Containing Mucopolysaccharides. Curr Ther Res Clin Exp. 2016 Nov 18;78:1-7. doi: 10.1016/j.curtheres.2016.11.001. eCollection 2016.
PubMed 28053674
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01691716
- Acronym / sponsor ID
- Tendoactive / PRJ-00014
- Conditions
- Achilles Tendinopathy
- Keywords
- Achilles tendinopathy, Tendoactive, Eccentric training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- BioibericaIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tendoactive | Experimental | Drug: TendoactiveTendoactive dosage: 3 capsules per day |
| Eccentric training | Active comparator | Behavioral: Eccentric trainingProtocol published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360) |
| Tendoactive and eccentric training | Active comparator | Drug: Tendoactive, Behavioral: Eccentric trainingTendoactive dosage: 3 capsules per day. Eccentric training: protocol described by Alfredson et al 1998 (Am J Sports Med 1998 26: 360) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TendoactiveFood supplement containing mucopolysaccharides, type I collagen and vitamin C | Drug | Tendoactive, Tendoactive and eccentric training |
| Eccentric trainingEccentric training program published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360) | Behavioural | Eccentric training, Tendoactive and eccentric training |
Primary outcome
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
5 secondary outcomes
Pain level at rest [VAS 0-10]
Time frame: 0, 6, 12 weeks
Pain level at exertion [VAS 0-10]
Time frame: 0, 6, 12weeks
Achilles transverse thickness by ultrasound
Time frame: 0, 6, 12 weeks
SF-36 v2 quality of life survey
Time frame: 0, 12 weeks
Patient satisfaction
Time frame: 6, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2014.
- Background: PubMed 9617396Alfredson H, Pietila T, Jonsson P, Lorentzon R. Heavy-load eccentric calf muscle training for the treatment of chronic Achilles tendinosis. Am J Sports Med. 1998 May-Jun;26(3):360-6. doi: 10.1177/03635465980260030301.
- Derived from this study: PubMed 28053674Balius R, Alvarez G, Baro F, Jimenez F, Pedret C, Costa E, Martinez-Puig D. A 3-Arm Randomized Trial for Achilles Tendinopathy: Eccentric Training, Eccentric Training Plus a Dietary Supplement Containing Mucopolysaccharides, or Passive Stretching Plus a Dietary Supplement Containing Mucopolysaccharides. Curr Ther Res Clin Exp. 2016 Nov 18;78:1-7. doi: 10.1016/j.curtheres.2016.11.001. eCollection 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tendoactive and Eccentric training in people with Achilles Tendinopathy, run by Bioiberica at 6 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in VISA-A score at 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01691716, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2014.