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Completed

NCT Number: NCT03743441

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.

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Key information

Conditions

Achilles Tendinopathy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bergen

Bergen, Hordaland, 5008, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-level laser therapy

Other

LLLT, 904 nm wavelength, 3 Joules per treatment point in accordance with World Association for Laser Therapy (WALT) guidelines.

Other names: Photobiomodulation

Sham Low-level Laser Therapy

Other

Same procedure as in the LLLT group with the exception of laser irradiation (0 mW mean output power).

Other names: Sham Photobiomodulation

Exercise therapy

Other

Concentric and eccentric exercises with a total duration of approximately 20 minutes.

Cryotherapy

Other

Twenty minutes of cryotherapy applied to the Achilles tendon.

Primary outcomes

  1. The VISA-A questionnaire: An index of the severity of Achilles tendinopathy

    Time frame: Change from baseline to week 4 and 12

    Range 0-100

  2. Pain (Numerical Rating Scale)

    Time frame: Change from baseline to week 4 and 12

    Range 0-10

Secondary outcomes

  1. Pain pressure threshold algometry

    Time frame: 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.

  2. Palpation tenderness

    Time frame: 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.

  3. Single legged heel raise

    Time frame: 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.

  4. Jump for distance

    Time frame: Change from baseline to week 4 and 12

    One leg take-off and landing

  5. Thickness of the Achilles tendon

    Time frame: Change from baseline to week 4 and 12

    Measured with real time ultrasonography in a longitudinal and sagittal view.

  6. Neovascularization in the Achilles tendon

    Time frame: Change from baseline to week 4 and 12

    Doppler activity measured with real time ultrasonography in a longitudinal and sagittal view.

  7. Qualitative assessment of structural changes of the Achilles tendon

    Time frame: 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.

  8. Qualitative assessment of effusion within of the Achilles tendon

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Collaborators

  • Norwegian Fund for Postgraduate Training in Physiotherapy
  • Universidade do Vale do Paraíba

Registry information

Official study title

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

Acronym: PhyCAT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 16, 2018
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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