Physiotherapy Treatment for Chronic Achilles Tendinopathy (PhyCAT)

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

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.

Study Overview

• Status: Completed
• Conditions: Achilles Tendinopathy
• Intervention / Treatment: Other: Low-level Laser Therapy; Other: Exercise therapy; Other: Cryotherapy; Other: Sham Low-level Laser Therapy

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Hordaland
    • Bergen, Hordaland, Norway, 5008
      • University of Bergen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Exercise + Cryotherapy + LLLT	Other: Low-level Laser Therapy; LLLT, 904 nm wavelength, 3 Joules per treatment point in accordance with World Association for Laser Therapy (WALT) guidelines.; Other Names: Photobiomodulation; Other: Exercise therapy; Concentric and eccentric exercises with a total duration of approximately 20 minutes.; Other: Cryotherapy; Twenty minutes of cryotherapy applied to the Achilles tendon.
Sham Comparator: Exercise + Cryotherapy + Sham LLLT	Other: Exercise therapy; Concentric and eccentric exercises with a total duration of approximately 20 minutes.; Other: Cryotherapy; Twenty minutes of cryotherapy applied to the Achilles tendon.; Other: Sham Low-level Laser Therapy; Same procedure as in the LLLT group with the exception of laser irradiation (0 mW mean output power).; Other Names: Sham Photobiomodulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline to week 4 and 12
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.	Change from baseline to week 4 and 12
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.	Change from baseline to week 4 and 12
Jump for distance	One leg take-off and landing	Change from baseline to week 4 and 12
Thickness of the Achilles tendon	Measured with real time ultrasonography in a longitudinal and sagittal view.	Change from baseline to week 4 and 12
Neovascularization in the Achilles tendon	Doppler activity measured with real time ultrasonography in a longitudinal and sagittal view.	Change from baseline to week 4 and 12
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.	Change from baseline to week 4 and 12
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.	Change from baseline to week 4 and 12

Collaborators and Investigators

• Sponsor: University of Bergen
• Collaborators: Universidade do Vale do Paraíba; Norwegian Fund for Postgraduate Training in Physiotherapy
• Investigators: Principal Investigator: Ingvill F Naterstad, MSc, University of Bergen

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: November 13, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 26, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Placebo-controlled; LLLT; RCT; Cryotherapy; Photobiomodulation; Exercise therapy; Low-level Laser Therapy; Randomized Clinical Trial; Chronic tendinopathy
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: 20161107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No