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Physiotherapy Treatment for Chronic Achilles Tendinopathy (PhyCAT)

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ClinicalTrials.gov Identifier: NCT03743441
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
Sponsor:
Collaborators:
Universidade do Vale do Paraíba
Norwegian Fund for Postgraduate Training in Physiotherapy
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Achilles Tendinopathy Other: Low-level Laser Therapy Other: Sham Low-level Laser Therapy Other: Exercise therapy Other: Cryotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.

Primary Purpose: Treatment
Official Title: A Double-blind Randomized Controlled Trial of Physiotherapy Treatment for Chronic Achilles Tendinopathy
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

Arm Intervention/treatment
Active Comparator: Exercise + Cryotherapy + LLLT Other: Low-level Laser Therapy
LLLT, 904 nm wavelength, 3 Joules per treatment point in accordance with World Association for Laser Therapy (WALT) guidelines.
Other Name: Photobiomodulation

Other: Exercise therapy
Concentric and eccentric exercises with a total duration of approximately 20 minutes.

Other: Cryotherapy
Twenty minutes of cryotherapy applied to the Achilles tendon.

Sham Comparator: Exercise + Cryotherapy + Sham LLLT Other: Sham Low-level Laser Therapy
Same procedure as in the LLLT group with the exception of laser irradiation (0 mW mean output power).
Other Name: Sham Photobiomodulation

Other: Exercise therapy
Concentric and eccentric exercises with a total duration of approximately 20 minutes.

Other: Cryotherapy
Twenty minutes of cryotherapy applied to the Achilles tendon.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743441


Contacts
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Contact: Ingvill F Naterstad, MSc 55 58 60 21 ext 0047 ingvill.naterstad@uib.no
Contact: Jon Joensen, PhD 55 58 83 04 ext 0047 jon.joensen@uib.no

Locations
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Norway
University of Bergen Recruiting
Bergen, Hordaland, Norway, 5008
Contact: Jan M Bjordal, Prof    55 58 60 37 ext 0047    jan.bjordal@uib.no   
Sponsors and Collaborators
University of Bergen
Universidade do Vale do Paraíba
Norwegian Fund for Postgraduate Training in Physiotherapy
Investigators
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Principal Investigator: Ingvill F Naterstad, MSc University of Bergen

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Responsible Party: University of Bergen
ClinicalTrials.gov Identifier: NCT03743441     History of Changes
Other Study ID Numbers: 20161107
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Bergen:
Chronic tendinopathy
Low-level Laser Therapy
LLLT
Photobiomodulation
Cryotherapy
Exercise therapy
Randomized Clinical Trial
RCT
Placebo-controlled

Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries