Physiotherapy Treatment for Chronic Achilles Tendinopathy

Not Applicable

Completed

• Conditions: Achilles Tendinopathy
• Interventions: Other: Sham Low-level Laser Therapy; Other: Low-level Laser Therapy; Other: Exercise therapy; Other: Cryotherapy

• Registration Number: NCT03743441
• Lead Sponsor: University of Bergen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2018-11-13
• Study First Posted: 2018-11-16
• Primary Completion: 2019-05-31
• Study Completion: 2019-05-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-26
• Last Update Posted: 2020-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise + Cryotherapy + Sham LLLT	Exercise therapy	-
Exercise + Cryotherapy + LLLT	Exercise therapy	-
Exercise + Cryotherapy + Sham LLLT	Sham Low-level Laser Therapy	-
Exercise + Cryotherapy + LLLT	Cryotherapy	-
Exercise + Cryotherapy + LLLT	Low-level Laser Therapy	-
Exercise + Cryotherapy + Sham LLLT	Cryotherapy	-

Primary Outcome Measures

Name	Time	Method
The VISA-A questionnaire: An index of the severity of Achilles tendinopathy	Change from baseline to week 4 and 12	Range 0-100
Pain (Numerical Rating Scale)	Change from baseline to week 4 and 12	Range 0-10

Secondary Outcome Measures

Name	Time	Method
Pain pressure threshold algometry	Change from baseline to week 4 and 12	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.
Jump for distance	Change from baseline to week 4 and 12	One leg take-off and landing
Neovascularization in the Achilles tendon	Change from baseline to week 4 and 12	Doppler activity measured with real time ultrasonography in a longitudinal and sagittal view.
Qualitative assessment of structural changes of the Achilles tendon	Change from baseline to week 4 and 12	Structural changes are assessed by real time ultrasonography. The structural changes of the Achilles tendon is scored as absent, mild, moderate, or severe.
Palpation tenderness	Change from baseline to week 4 and 12	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	Change from baseline to week 4 and 12	The participant stands solely on one leg and lifts the heel of the floor. The distance from the heel to the floor is measured.
Thickness of the Achilles tendon	Change from baseline to week 4 and 12	Measured with real time ultrasonography in a longitudinal and sagittal view.
Qualitative assessment of effusion within of the Achilles tendon	Change from baseline to week 4 and 12	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.

Trial Locations

Locations (1)

University of Bergen; 🇳🇴 Bergen, Hordaland, Norway