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The Mechanical,Physiological and Therapeutic Effects of Eccentric Exercise Combined With Extracorporeal Shockwave Therapy in Athletes With Patellar Tendinopathy

Primary Purpose

Patellar Tendinopathy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Eccentric exercise
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellar Tendinopathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Competitive athletes
  • Pain at the inferior pole of the patella with training for at least 3 months
  • Tenderness at the inferior pole of the patella on palpation

Exclusion Criteria:

  • Patellofemoral pain syndrome, fat pad irritations, meniscus injury, osteoarthritis, rheumatoid arthritis or infections
  • History of fracture over lower limbs and inflammatory myopathies
  • Cortisone injuection and other interventions within 3 months
  • Contraindication to extracorporeal shockwave therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Combined

    Exercise

    Arm Description

    12 weeks eccentric exercise combined with 6 sessions of extracorporeal shockwave therapy in the initial 6 weeks

    12 weeks eccentric exercise combined with 6 sessions of sham extracorporeal shockwave therapy in the initial 6 weeks

    Outcomes

    Primary Outcome Measures

    Tendon stress in pascals at baseline
    Tendon stress measured by ultrasonography and dynamometry
    Change of tendon stress in pascals at 12 weeks
    Tendon stress measured by ultrasonography and dynamometry
    Change of tendon stress in pascals at 16 weeks
    Tendon stress measured by ultrasonography and dynamometry
    Tendon vascularity index as percentage at baseline
    Tendon vascularity measured by power doppler ultrasonography
    Change of tendon vascularity index as percentage at 12 weeks
    Tendon vascularity measured by power doppler ultrasonography
    Change of tendon vascularity index as percentage at 16 weeks
    Tendon vascularity measured by power doppler ultrasonography

    Secondary Outcome Measures

    Tendon related pain on visual analogy scale at baseline
    Maximal intensity of self-perceived pain in the past 7 days, pain during single-leg declined-squat test
    Change of tendon related pain on visual analogy scale at 12 weeks
    Maximal intensity of self-perceived pain in the past 7 days, pain during single-leg declined-squat test
    Change of tendon related pain on visual analogy scale at 16 weeks
    Maximal intensity of self-perceived pain in the past 7 days, pain during single-leg declined-squat test
    Tendon related dysfunction by questionnaire at baseline
    Victorian Institute of Sport Assessment Questionnaire - Patellar Tendon
    Change of tendon related dysfunction by questionnaire at 12 weeks
    Victorian Institute of Sport Assessment Questionnaire - Patellar Tendon
    Change of tendon related dysfunction by questionnaire at 16 weeks
    Victorian Institute of Sport Assessment Questionnaire - Patellar Tendon

    Full Information

    First Posted
    July 30, 2020
    Last Updated
    November 25, 2020
    Sponsor
    The Hong Kong Polytechnic University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04650997
    Brief Title
    The Mechanical,Physiological and Therapeutic Effects of Eccentric Exercise Combined With Extracorporeal Shockwave Therapy in Athletes With Patellar Tendinopathy
    Official Title
    The Mechanical,Physiological and Therapeutic Effects of Eccentric Exercise Combined With Extracorporeal Shockwave Therapy in Athletes With Patellar Tendinopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    February 16, 2011 (Actual)
    Primary Completion Date
    January 1, 2014 (Actual)
    Study Completion Date
    January 1, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Hong Kong Polytechnic University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Patellar tendinopathy is one of the most common injuries in jumping athletes. Changes in mechanical and physiological properties of tendon are the two proposed forms of pathogenesis. The efficacy of eccentric exercise when applied alone and combined with extrocoporeal shockwave therapy had been reported; however, the underlying treatment mechanisms of pain and dysfunction are not clear. This project aimed to explore the mechanical, physiological and therapeutic effects of eccentric exercise when applied as a single treatment and as an adjunct to extracorporeal shockwave therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Patellar Tendinopathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    43 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Combined
    Arm Type
    Experimental
    Arm Description
    12 weeks eccentric exercise combined with 6 sessions of extracorporeal shockwave therapy in the initial 6 weeks
    Arm Title
    Exercise
    Arm Type
    Sham Comparator
    Arm Description
    12 weeks eccentric exercise combined with 6 sessions of sham extracorporeal shockwave therapy in the initial 6 weeks
    Intervention Type
    Behavioral
    Intervention Name(s)
    Eccentric exercise
    Other Intervention Name(s)
    Extracoporeal shockwave therapy (Minilith SL1, Storz Medical)
    Intervention Description
    Knee eccentric exercise with sham or focused extrocorporeal shockwave therapy for 12 weeks
    Primary Outcome Measure Information:
    Title
    Tendon stress in pascals at baseline
    Description
    Tendon stress measured by ultrasonography and dynamometry
    Time Frame
    Before intervention
    Title
    Change of tendon stress in pascals at 12 weeks
    Description
    Tendon stress measured by ultrasonography and dynamometry
    Time Frame
    12 weeks
    Title
    Change of tendon stress in pascals at 16 weeks
    Description
    Tendon stress measured by ultrasonography and dynamometry
    Time Frame
    16 weeks
    Title
    Tendon vascularity index as percentage at baseline
    Description
    Tendon vascularity measured by power doppler ultrasonography
    Time Frame
    Before intervention
    Title
    Change of tendon vascularity index as percentage at 12 weeks
    Description
    Tendon vascularity measured by power doppler ultrasonography
    Time Frame
    12 weeks
    Title
    Change of tendon vascularity index as percentage at 16 weeks
    Description
    Tendon vascularity measured by power doppler ultrasonography
    Time Frame
    16 weeks
    Secondary Outcome Measure Information:
    Title
    Tendon related pain on visual analogy scale at baseline
    Description
    Maximal intensity of self-perceived pain in the past 7 days, pain during single-leg declined-squat test
    Time Frame
    Before intervention
    Title
    Change of tendon related pain on visual analogy scale at 12 weeks
    Description
    Maximal intensity of self-perceived pain in the past 7 days, pain during single-leg declined-squat test
    Time Frame
    12 weeks
    Title
    Change of tendon related pain on visual analogy scale at 16 weeks
    Description
    Maximal intensity of self-perceived pain in the past 7 days, pain during single-leg declined-squat test
    Time Frame
    16 weeks
    Title
    Tendon related dysfunction by questionnaire at baseline
    Description
    Victorian Institute of Sport Assessment Questionnaire - Patellar Tendon
    Time Frame
    Before intervention
    Title
    Change of tendon related dysfunction by questionnaire at 12 weeks
    Description
    Victorian Institute of Sport Assessment Questionnaire - Patellar Tendon
    Time Frame
    12 weeks
    Title
    Change of tendon related dysfunction by questionnaire at 16 weeks
    Description
    Victorian Institute of Sport Assessment Questionnaire - Patellar Tendon
    Time Frame
    16 weeks

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Competitive athletes Pain at the inferior pole of the patella with training for at least 3 months Tenderness at the inferior pole of the patella on palpation Exclusion Criteria: Patellofemoral pain syndrome, fat pad irritations, meniscus injury, osteoarthritis, rheumatoid arthritis or infections History of fracture over lower limbs and inflammatory myopathies Cortisone injuection and other interventions within 3 months Contraindication to extracorporeal shockwave therapy

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No plan

    Learn more about this trial

    The Mechanical,Physiological and Therapeutic Effects of Eccentric Exercise Combined With Extracorporeal Shockwave Therapy in Athletes With Patellar Tendinopathy

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