Back to results

The Efficacy of Tendoactive, Eccentric Training, and the Combination of Both as a Treatment of Achilles Tendinopathy (Tendoactive)

Primary Purpose

Achilles Tendinopathy

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Tendoactive

Eccentric training

About this trial

This is an interventional treatment trial for Achilles Tendinopathy focused on measuring Achilles tendinopathy, Tendoactive, Eccentric training

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CEARE
CMI
Clínica CEMTRO
AMS - Centro de Ejercicio
Centro de Medicina y Deporte
Clínica Traumatológica

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Tendoactive

Eccentric training

Tendoactive and eccentric training

Arm Description

Tendoactive dosage: 3 capsules per day

Protocol published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)

Tendoactive dosage: 3 capsules per day. Eccentric training: protocol described by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain level at rest [VAS 0-10]

Pain level at exertion [VAS 0-10]

Achilles transverse thickness by ultrasound

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

Patient satisfaction

Patient satisfaction will be evaluated using a subjective questionnaire.

Full Information

NCT ID

NCT01691716

First Posted

September 13, 2012

Last Updated

February 25, 2014

Sponsor

Bioiberica

1. Study Identification

Unique Protocol Identification Number

NCT01691716

Brief Title

The Efficacy of Tendoactive, Eccentric Training, and the Combination of Both as a Treatment of Achilles Tendinopathy

Acronym

Tendoactive

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bioiberica

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Achilles Tendinopathy

Keywords

Achilles tendinopathy, Tendoactive, Eccentric training

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tendoactive

Arm Type

Experimental

Arm Description

Tendoactive dosage: 3 capsules per day

Arm Title

Eccentric training

Arm Type

Active Comparator

Arm Description

Protocol published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)

Arm Title

Tendoactive and eccentric training

Arm Type

Active Comparator

Arm Description

Tendoactive dosage: 3 capsules per day. Eccentric training: protocol described by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)

Intervention Type

Drug

Intervention Name(s)

Tendoactive

Intervention Description

Food supplement containing mucopolysaccharides, type I collagen and vitamin C

Intervention Type

Behavioral

Intervention Name(s)

Eccentric training

Intervention Description

Eccentric training program published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)

Primary Outcome Measure Information:

Title

Change from Baseline in VISA-A score at 12 weeks

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Pain level at rest [VAS 0-10]

Time Frame

0, 6, 12 weeks

Title

Pain level at exertion [VAS 0-10]

Time Frame

0, 6, 12weeks

Title

Achilles transverse thickness by ultrasound

Description

Ultrasound evaluation of Achilles tendon. Maximum thickness will be recorded in the midportion of the affected Achilles tendon

Time Frame

0, 6, 12 weeks

Title

SF-36 v2 quality of life survey

Time Frame

0, 12 weeks

Title

Patient satisfaction

Description

Patient satisfaction will be evaluated using a subjective questionnaire.

Time Frame

6, 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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 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

Facility Information:

Facility Name

CEARE

City

Esplugues de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08950

Country

Spain

Facility Name

CMI

City

Barcelona

Country

Spain

Facility Name

Clínica CEMTRO

City

Madrid

Country

Spain

Facility Name

AMS - Centro de Ejercicio

City

Malaga

Country

Spain

Facility Name

Centro de Medicina y Deporte

City

Toledo

Country

Spain

Facility Name

Clínica Traumatológica

City

Valladolid

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

9617396

Citation

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.

Results Reference

background

PubMed Identifier

28053674

Citation

Balius 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.

Results Reference

derived

Learn more about this trial

The Efficacy of Tendoactive, Eccentric Training, and the Combination of Both as a Treatment of Achilles Tendinopathy

We'll reach out to this number within 24 hrs