Achilles Tendinopathy
Conditions
Keywords
Chronic tendinopathy, Low-level Laser Therapy, LLLT, Photobiomodulation, Cryotherapy, Exercise therapy, Randomized Clinical Trial, RCT, Placebo-controlled
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.
Interventions
OTHERLow-level Laser Therapy
LLLT, 904 nm wavelength, 3 Joules per treatment point in accordance with World Association for Laser Therapy (WALT) guidelines.
Same procedure as in the LLLT group with the exception of laser irradiation (0 mW mean output power).
OTHERExercise therapy
Concentric and eccentric exercises with a total duration of approximately 20 minutes.
OTHERCryotherapy
Twenty minutes of cryotherapy applied to the Achilles tendon.
Sponsors
Universidade do Vale do Paraíba
Norwegian Fund for Postgraduate Training in Physiotherapy
University of Bergen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Jump for distance | Change from baseline to week 4 and 12 | One leg take-off and landing |
| Thickness of the Achilles tendon | Change from baseline to week 4 and 12 | Measured with real time ultrasonography in a longitudinal and sagittal view. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Norway
Outcome results
None listed