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Physiotherapy Treatment for Chronic Achilles Tendinopathy

NCT ID: NCT03743441

Last Updated: 2020-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Achilles Tendinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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Exercise + Cryotherapy + LLLT

Group Type ACTIVE_COMPARATOR

Low-level Laser Therapy

Intervention Type OTHER

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

Exercise therapy

Intervention Type OTHER

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

Cryotherapy

Intervention Type OTHER

Twenty minutes of cryotherapy applied to the Achilles tendon.

Exercise + Cryotherapy + Sham LLLT

Group Type SHAM_COMPARATOR

Sham Low-level Laser Therapy

Intervention Type OTHER

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

Exercise therapy

Intervention Type OTHER

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

Cryotherapy

Intervention Type OTHER

Twenty minutes of cryotherapy applied to the Achilles tendon.

Interventions

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Low-level Laser Therapy

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

Intervention Type OTHER

Sham Low-level Laser Therapy

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

Intervention Type OTHER

Exercise therapy

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

Intervention Type OTHER

Cryotherapy

Twenty minutes of cryotherapy applied to the Achilles tendon.

Intervention Type OTHER

Other Intervention Names

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Photobiomodulation Sham Photobiomodulation

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade do Vale do Paraíba

OTHER

Sponsor Role collaborator

Norwegian Fund for Postgraduate Training in Physiotherapy

OTHER

Sponsor Role collaborator

University of Bergen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ingvill F Naterstad, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

Locations

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University of Bergen

Bergen, Hordaland, Norway

Site Status

Countries

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Norway

Other Identifiers

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20161107

Identifier Type: -

Identifier Source: org_study_id