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

NCT01691716 | Completed

• 1 other identifier: PRJ-00014
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

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.

Conditions

Achilles Tendinopathy

Keywords

Achilles tendinopathy; Tendoactive; Eccentric training

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (5)

• 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

Study Arms (3)

Tendoactive

EXPERIMENTAL

Tendoactive dosage: 3 capsules per day

Drug: Tendoactive

Eccentric training

ACTIVE COMPARATOR

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

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)

Drug: Tendoactive; Behavioral: Eccentric training

Interventions

Tendoactive DRUG

Food supplement containing mucopolysaccharides, type I collagen and vitamin C

Tendoactive; Tendoactive and eccentric training

Eccentric training BEHAVIORAL

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

Eccentric training; Tendoactive and eccentric training

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bioiberica: lead

Study Sites (6)

CMI

Barcelona, Barcelona, Spain

Location

CEARE

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Clínica CEMTRO

Madrid, Madrid, Spain

Location

AMS - Centro de Ejercicio

Málaga, Malaga, Spain

Location

Centro de Medicina y Deporte

Toledo, Toledo, Spain

Location

Clínica Traumatológica

Valladolid, Valladolid, Spain

Location

Related Publications (2)

• 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.

  PMID: 9617396 BACKGROUND

• 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.

  PMID: 28053674 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2012
• First Posted: September 25, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 26, 2014

Record last verified: 2014-02

Locations

ES (6)