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Comparison of two exercise protocols for insertional Achilles tedinopathy rehabilitation


- candidate number27104
- NTR NumberNTR6314
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-apr-2017
- Secondary IDsNL58148.042.16 ABR
- Public TitleComparison of two exercise protocols for insertional Achilles tedinopathy rehabilitation
- Scientific TitleThe effect of an isometric plus eccentric-concentric exercise protocol compared to the usual care eccentric exercise protocol on Achilles tendon pain and structure in subjects diagnosed with Insertional Achilles Tendinopathy A pilot study
- ACRONYMIAT study
- hypothesisExercise leads to pain and funcional improvement in patients diagnosed with insertional Achilles tendinopathy
- Healt Condition(s) or Problem(s) studiedAchilles tendinopathy
- Inclusion criteria- Individuals of both sexes, aged between 18 and 55 years
- Chronic pain in the Achilles tendon insertion for more than 3 months
- Pain during the palpation
- Abnormal ultrasound imaging (hypoechoic areas, irregular fiber orientation and thickening of the tendon).
- Exclusion criteria- Imaging abnormalities as: superficial or retrocalcaneal fluid on the ultrasound examination as a sign of bursitis, or changes on mid-portion tendon structure;
- Systematic disease (eg, diabetes, rheumatoid arthritis);
- Prior Achilles tendon rupture;
- Prior injections for Achilles tendinopathy treatment;
- Patient that performed eccentric calf-muscle training > 4 weeks under the supervision of a physical therapist before;
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 18-apr-2017
- planned closingdate18-apr-2018
- Target number of participants30
- InterventionsEccentric exercise and Isometric exercise plus concentric exercise
- Primary outcomePain during calf-raise test
- Secondary outcome- Tendon Structure determined by the ultrasound tissue characterization (UTC)
- VISA-A questionnaire
- SF- 36 questionnaire
- Impact on work [Quality - Quantity questionnaire (QQ-q) and Work ability index (WAI)]
- Pain score
- Patients impression of improvement
- Timepoints- pretreatment (Baseline)
- 4 weeks after baseline
- 8 weeks after baseline
- 12 weeks after baseline
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Lucas Maciel Rabello
- CONTACT for SCIENTIFIC QUERIES Lucas Maciel Rabello
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
CNPq - National Council for Scientific and Technological Development
- Publications
- Brief summaryRatinale:
Achilles tendinopathy (AT) is a common injury that normally affects physically active people and the incidence increases with age. Several studies have shown the efficacy of the eccentric exercises protocol as treatment in patients diagnosed with mid-portion AT. However, few studies assessed the effect of eccentric exercise in patients with insertional Achilles tendinopathy (IAT) and results are inconclusive.

Objectives:
The primary objective of this pilot study is to determine the effect of an isometric exercises plus eccentric-concentric exercise protocol compared to the usual care eccentric exercise protocol on Achilles tendon pain and structure in subjects diagnosed with IAT.

Study design:
Single blinded, pilot study using a 2 group design with a treatment period of 12 weeks.

Study population:
Patients diagnosed with insertional Achilles tendinopathy

Intervention:
One group will perform eccentric exercise during 12 weeks, the other group will perform isometric exercise during 4 weeks and after concentric-eccentric exercise during 8 weeks.

Main study parameters/endpoints:
Pain during calf-raise test
- Main changes (audit trail)
- RECORD17-apr-2017 - 24-mei-2017


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