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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

Tracking Information
First Submitted Date  ICMJE November 6, 2018
First Posted Date  ICMJE November 16, 2018
Last Update Posted Date November 16, 2018
Actual Study Start Date  ICMJE August 1, 2017
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
  • 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
  • Pain (Numerical Rating Scale) [ Time Frame: Change from baseline to week 4 and 12 ]
    Range 0-10
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
  • 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.
  • 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.
  • 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.
  • Jump for distance [ Time Frame: Change from baseline to week 4 and 12 ]
    One leg take-off and landing
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physiotherapy Treatment for Chronic Achilles Tendinopathy
Official Title  ICMJE A Double-blind Randomized Controlled Trial of Physiotherapy Treatment for Chronic Achilles Tendinopathy
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Achilles Tendinopathy
Intervention  ICMJE
  • 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: 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.
Study Arms  ICMJE
  • Active Comparator: Exercise + Cryotherapy + LLLT
    Interventions:
    • Other: Low-level Laser Therapy
    • Other: Exercise therapy
    • Other: Cryotherapy
  • Sham Comparator: Exercise + Cryotherapy + Sham LLLT
    Interventions:
    • Other: Sham Low-level Laser Therapy
    • Other: Exercise therapy
    • Other: Cryotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 13, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2019
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03743441
Other Study ID Numbers  ICMJE 20161107
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Bergen
Study Sponsor  ICMJE University of Bergen
Collaborators  ICMJE
  • Universidade do Vale do Paraíba
  • Norwegian Fund for Postgraduate Training in Physiotherapy
Investigators  ICMJE
Principal Investigator: Ingvill F Naterstad, MSc University of Bergen
PRS Account University of Bergen
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP