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Effectiveness of Reducing Tendon Compression in the Treatment of Insertional Achilles Tendinopathy

NCT05456620 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-08-07

No results posted yet for this study

Summary

Insertional Achilles tendinopathy is a disabling injury that is common in running athletes. Exercise therapy is considered the best treatment option, but there is still no agreement on the modalities. For example, it is thought that compression overload may be a major cause of tendinopathy and should therefore be restricted during rehabilitation. However, this recommendation is based on expert opinion and not on hard scientific evidence. Therefore, this randomised controlled trial (RCT) will investigate whether a therapy that limits the amount of compression of the tendon during a progressive tendon-loading rehabilitation protocol actually has better outcomes in athletes with insertional Achilles tendinopathy.

Athletes with insertional Achilles tendinopathy will be randomised into two treatment groups; (1) an experimental rehabilitation protocol in which the amount of tendon compression is limited and (2) a control rehabilitation protocol in which the amount of tendon compression is not limited and is rather high. Both treatments consist of supervised progressive tendon-loading exercise therapy and patient education. In addition, the experimental group will also receive heel inserts to limit the amount of dorsiflexion during sports or daily activities. At baseline, at 12 weeks (end of intervention) and at 24 weeks (follow-up), pain, functionality, structure and intratendinous pressure will be determined.

Conditions

  • Insertional Achilles Tendinopathy

Interventions

OTHER

Exercise therapy

The intervention treatment consists of a progressive 4-stage, criteria-based exercise protocol, in which the amount of tendon compression is limited. This includes: 1. Education: Specific information on the importance of limiting tendon compression during rehabilitation, as well as general information on load management, the importance of active exercise therapy and setting expectations. 2. Orthotic treatment: heel inserts to reduce ankle dorsiflexion during daily activities and sports 3. Physiotherapy: Progressive tendon-loading exercise therapy (4 phases) restricting the amount of tendon compression by limiting dorsiflexion of the ankle and prohibiting stretching

OTHER

Exercise therapy (usual care)

The control treatment consists of a progressive 4-phase, criteria-based exercise protocol, in which the amount of tendon compression is not limited. This includes: 1. Education: general information on load management, the importance of active exercise therapy and setting expectations. 2. No orthotic treatment. 3. Physiotherapy: Progressive tendon-loading exercise therapy (4 phases) without any restriction around tendon compression and encouraging stretching

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Luc Vanden Bossche · Department of Rehabilitation Sciences, Ghent University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-05
Primary Completion
2024-08-01
Completion
2024-08-01

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05456620 on ClinicalTrials.gov