Physiotherapy Treatment for Chronic Achilles Tendinopathy

Achilles Tendinopathy Clinical Trial

— PhyCAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03743441
• Other study ID #: 20161107
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: May 31, 2019

Study information

• Verified date: October 2020
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Achilles Tendinopathy
• Tendinopathy

Intervention

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

Locations

Country	Name	City	State
Norway	University of Bergen	Bergen	Hordaland

Sponsors (3)

Lead Sponsor	Collaborator
University of Bergen	Norwegian Fund for Postgraduate Training in Physiotherapy, Universidade do Vale do Paraíba

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The VISA-A questionnaire: An index of the severity of Achilles tendinopathy	Range 0-100	Change from baseline to week 4 and 12
Primary	Pain (Numerical Rating Scale)	Range 0-10	Change from baseline to week 4 and 12
Secondary	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
Secondary	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
Secondary	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
Secondary	Jump for distance	One leg take-off and landing	Change from baseline to week 4 and 12
Secondary	Thickness of the Achilles tendon	Measured with real time ultrasonography in a longitudinal and sagittal view.	Change from baseline to week 4 and 12
Secondary	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
Secondary	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
Secondary	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