NCT03743441

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 16, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

1.8 years

First QC Date

November 6, 2018

Last Update Submit

October 26, 2020

Conditions

Achilles Tendinopathy

Keywords

Chronic tendinopathyLow-level Laser TherapyLLLTPhotobiomodulationCryotherapyExercise therapyRandomized Clinical TrialRCTPlacebo-controlled

Outcome Measures

Primary Outcomes (2)

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

    Range 0-100

    Change from baseline to week 4 and 12

  • Pain (Numerical Rating Scale)

    Range 0-10

    Change from baseline to week 4 and 12

Secondary Outcomes (8)

  • Pain pressure threshold algometry

    Change from baseline to week 4 and 12

  • Palpation tenderness

    Change from baseline to week 4 and 12

  • Single legged heel raise

    Change from baseline to week 4 and 12

  • Jump for distance

    Change from baseline to week 4 and 12

  • Thickness of the Achilles tendon

    Change from baseline to week 4 and 12

  • +3 more secondary outcomes

Study Arms (2)

Exercise + Cryotherapy + LLLT

ACTIVE COMPARATOR
Other: Low-level Laser TherapyOther: Exercise therapyOther: Cryotherapy

Exercise + Cryotherapy + Sham LLLT

SHAM COMPARATOR
Other: Sham Low-level Laser TherapyOther: Exercise therapyOther: Cryotherapy

Interventions

Low-level Laser TherapyOTHER

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

Also known as: Photobiomodulation
Exercise + Cryotherapy + LLLT
Sham Low-level Laser TherapyOTHER

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

Also known as: Sham Photobiomodulation
Exercise + Cryotherapy + Sham LLLT
Exercise therapyOTHER

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

Exercise + Cryotherapy + LLLTExercise + Cryotherapy + Sham LLLT
CryotherapyOTHER

Twenty minutes of cryotherapy applied to the Achilles tendon.

Exercise + Cryotherapy + LLLTExercise + Cryotherapy + Sham LLLT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bergen

Bergen, Hordaland, 5008, Norway

Location

MeSH Terms

Interventions

Low-Level Light TherapyExercise TherapyCryotherapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapyRehabilitationAftercareContinuity of Patient CarePatient CarePhysical Therapy Modalities

Study Officials

  • Ingvill F Naterstad, MSc

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2018

First Posted

November 16, 2018

Study Start

August 1, 2017

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

October 27, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)