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

NCT05456620 | Completed

• 1 other identifier: BC-11818
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Exercise therapy; Tendon compression; Tendinopathy

Outcome Measures

Primary Outcomes (2)

• The change of the Victorian Institute of Sports Assessment-Achilles Questionnaire (VISA-A) score over 12 weeks

  The VISA-A score is a measure of pain and lower limb function (disability) associated with Achilles tendinopathy. A higher score indicates a better outcome and a 10 point increase is accepted as being clinically meaningful.

  12 weeks (at the end of intervention)

• The change of the Victorian Institute of Sports Assessment-Achilles Questionnaire (VISA-A) score over 24 weeks

  The VISA-A score is a measure of pain and lower limb function (disability) associated with Achilles tendinopathy. A higher score indicates a better outcome and a 10 point increase is accepted as being clinically meaningful.

  24 weeks (at follow-up)

Secondary Outcomes (13)

• Subjective patient satisfaction

  This will be assessed at the end of the intervention (week 12) and at follow-up (week 24).

• Return to sports rate

  This will be assessed at the end of the intervention (week 12) and at follow-up (week 24).

• Hop test

  This will be assessed at the start (week 0), at the end of the intervention (week 12) and at follow-up (week 24).

• Lower Extremity Functional Scale

  This will be assessed at the start (week 0), at the end of the intervention (week 12) and at follow-up (week 24).

• Tampa scale for kinesiophobia (TSK)

  This will be assessed at the start (week 0), at the end of the intervention (week 12) and at follow-up (week 24).

Other Outcomes (2)

• Ultrasound examination to assess presence of rectrocalcaneal bursitis and/or intratendinous calcifications

  This will be assessed at baseline (week 0)

• X-ray to assess presence of Haglund's deformity

  This will be assessed at baseline (week 0)

Study Arms (2)

Low Tendon Compression Rehabilitation (LTCR)

EXPERIMENTAL

A progressive, criteria-based, 4-stage exercise protocol in which the amount of tendon compression is limited (12 weeks).

Other: Exercise therapy

High Tendon Compression Rehabilitation (HTCR)

ACTIVE COMPARATOR

A progressive, criteria-based, 4-stage exercise protocol in which the amount of tendon compression is not limited (12 weeks).

Other: Exercise therapy (usual care)

Interventions

Exercise therapy OTHER

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

Low Tendon Compression Rehabilitation (LTCR)

Exercise therapy (usual care) OTHER

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

High Tendon Compression Rehabilitation (HTCR)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60 years old
• Diagnosed with insertional Achilles Tendinopathy by a sports medicine physician
• Have experienced symptoms for more than 3 months but less than 3 years
• A severity level of less than 80 points on the VISA-A score
• Playing running-based sports at least twice a week
• Able to comply with both exercise programs

You may not qualify if:

• Have a history of Achilles tendon rupture or surgery
• Have other disorders of the Achilles tendon or ankle (mid-portional Achilles tendinopathy, paratenonitis, osteoarthritis,...)
• Have rheumatological disorder (e.g. Spondylitis Ankylosis)
• Have metabolic or endocrine disorders, such as type I or type II diabetes
• Have had an Achilles injection in the past 3 months
• Have other conditions that prevent following an active exercise programme
• Have already been treated with physiotherapy, shockwave therapy or orthotics in the past 3 months
• Medication use with (fluoro)quinolones antibiotic in the past 2 years
• Currently pregnant

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Department of rehabilitation sciences

Ghent, 9000, Belgium

Location

Related Publications (1)

• Pringels L, Capelleman R, Van den Abeele A, Burssens A, Planckaert G, Wezenbeek E, Vanden Bossche L. Effectiveness of reducing tendon compression in the rehabilitation of insertional Achilles tendinopathy: a randomised clinical trial. Br J Sports Med. 2025 Apr 24;59(9):640-650. doi: 10.1136/bjsports-2024-109138.

  PMID: 40011018 DERIVED

MeSH Terms

Conditions

Tendinopathy

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Luc Vanden Bossche

  Department of Rehabilitation Sciences, Ghent University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The principal investigator (LP) will be blinded to the assigned treatment throughout the data collection period. During the study, patients will be asked not to discuss their treatment exercises with the principal investigator but to consult an independent second sports physician (AB) if they have any questions about the therapy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 13, 2022
• Study Start: December 5, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)