Physiotherapy Treatment for Chronic Achilles Tendinopathy

Study Overview
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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.

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

Conditions
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Achilles Tendinopathy

Intervention / Treatment
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* Other: Low-level Laser Therapy
* Other: Sham Low-level Laser Therapy
* Other: Exercise therapy
* Other: Cryotherapy


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic tendinopathy, Low-level Laser Therapy, LLLT, Photobiomodulation, Cryotherapy, Exercise therapy, Randomized Clinical Trial, RCT, Placebo-controlled