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Physiotherapy Treatment for Chronic Achilles Tendinopathy (PhyCAT)

Primary Purpose

Achilles Tendinopathy

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Low-level Laser Therapy

Sham Low-level Laser Therapy

Exercise therapy

Cryotherapy

About this trial

This is an interventional treatment trial for Achilles Tendinopathy focused on measuring Chronic tendinopathy, Low-level Laser Therapy, LLLT, Photobiomodulation, Cryotherapy, Exercise therapy, Randomized Clinical Trial, RCT, Placebo-controlled

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Achilles tendinopathy with a minimum duration of three months, pathological appearance of the Achilles tendon with thickened tendon and structural changes of the tendons matrix.

Exclusion Criteria:

Cortisone injection within the last 6 months, systemic inflammatory disease, previous suture/surgery of the Achilles tendon, pregnancy or familial hypercholesterolemia.

Sites / Locations

University of Bergen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Exercise + Cryotherapy + LLLT

Exercise + Cryotherapy + Sham LLLT

Arm Description

Outcomes

Primary Outcome Measures

The VISA-A questionnaire: An index of the severity of Achilles tendinopathy

Range 0-100

Pain (Numerical Rating Scale)

Range 0-10

Secondary Outcome Measures

Pain pressure threshold algometry

Algometer placed upon the Achilles tendon at the most sensitive spot identified by palpation. If it is unclear what the most sensitive spot is, the algometer is placed 2 cm proximal from the calcaneus.

Palpation tenderness

The Achilles tendon is palpated by the assessor while the participant is lying prone. The participant indicates whether the pressure produces pain by answering yes/no.

Single legged heel raise

The participant stands solely on one leg and lifts the heel of the floor. The distance from the heel to the floor is measured.

Jump for distance

One leg take-off and landing

Thickness of the Achilles tendon

Measured with real time ultrasonography in a longitudinal and sagittal view.

Neovascularization in the Achilles tendon

Doppler activity measured with real time ultrasonography in a longitudinal and sagittal view.

Qualitative assessment of structural changes of the Achilles tendon

Structural changes are assessed by real time ultrasonography. The structural changes of the Achilles tendon is scored as absent, mild, moderate, or severe.

Qualitative assessment of effusion within of the Achilles tendon

Amount of effusion is assessed by real time ultrasonography. The amount of effusion within and around the Achilles tendon is scored as absent, mild, moderate, or severe.

Full Information

NCT ID

NCT03743441

First Posted

November 6, 2018

Last Updated

October 26, 2020

Sponsor

University of Bergen

Collaborators

Universidade do Vale do Paraíba, Norwegian Fund for Postgraduate Training in Physiotherapy

1. Study Identification

Unique Protocol Identification Number

NCT03743441

Brief Title

Physiotherapy Treatment for Chronic Achilles Tendinopathy

Acronym

PhyCAT

Official Title

A Double-blind Randomized Controlled Trial of Physiotherapy Treatment for Chronic Achilles Tendinopathy

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

August 1, 2017 (Actual)

Primary Completion Date

May 31, 2019 (Actual)

Study Completion Date

May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Bergen

Collaborators

Universidade do Vale do Paraíba, Norwegian Fund for Postgraduate Training in Physiotherapy

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Laser treatment with the proper dosage has been found effective in the treatment of chronic Achilles tendinopathy, and animal research indicate that a combination of cryotherapy followed by LLLT could yield an even better result. Thus, the main purpose of this project is to test if the addition of low level laser therapy can enhance the treatment result of exercise and cryotherapy in patients with chronic Achilles tendinopathy, yielding less pain and higher function.

6. Conditions and Keywords

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

Achilles Tendinopathy

Keywords

Chronic tendinopathy, Low-level Laser Therapy, LLLT, Photobiomodulation, Cryotherapy, Exercise therapy, Randomized Clinical Trial, RCT, Placebo-controlled

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Two identical laser devices are used, where one is active and the other is sham. One laser device has a 3x60 mW output power and the other one has 0 mW output power (sham). These are labelled with yellow or blue tape by a secretary who is otherwise not participating in the study. Since the laser device has an invisible beam (904 nm wavelength) and is of such low power that heat is not detected, both the participant and the clinician will be blinded.

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise + Cryotherapy + LLLT

Arm Type

Active Comparator

Arm Title

Exercise + Cryotherapy + Sham LLLT

Arm Type

Sham Comparator

Intervention Type

Other

Intervention Name(s)

Low-level Laser Therapy

Other Intervention Name(s)

Photobiomodulation

Intervention Description

LLLT, 904 nm wavelength, 3 Joules per treatment point in accordance with World Association for Laser Therapy (WALT) guidelines.

Intervention Type

Other

Intervention Name(s)

Sham Low-level Laser Therapy

Other Intervention Name(s)

Sham Photobiomodulation

Intervention Description

Same procedure as in the LLLT group with the exception of laser irradiation (0 mW mean output power).

Intervention Type

Other

Intervention Name(s)

Exercise therapy

Intervention Description

Concentric and eccentric exercises with a total duration of approximately 20 minutes.

Intervention Type

Other

Intervention Name(s)

Cryotherapy

Intervention Description

Twenty minutes of cryotherapy applied to the Achilles tendon.

Primary Outcome Measure Information:

Title

The VISA-A questionnaire: An index of the severity of Achilles tendinopathy

Description

Range 0-100

Time Frame