The Mechanical,Physiological and Therapeutic Effects of Eccentric Exercise Combined With Extracorporeal Shockwave Therapy in Athletes With Patellar Tendinopathy
1 other identifier
interventional
43
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2011
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 30, 2020
CompletedFirst Posted
Study publicly available on registry
December 3, 2020
CompletedDecember 3, 2020
February 1, 2011
2.9 years
July 30, 2020
November 25, 2020
Conditions
Outcome Measures
Primary Outcomes (6)
Tendon stress in pascals at baseline
Tendon stress measured by ultrasonography and dynamometry
Before intervention
Change of tendon stress in pascals at 12 weeks
Tendon stress measured by ultrasonography and dynamometry
12 weeks
Change of tendon stress in pascals at 16 weeks
Tendon stress measured by ultrasonography and dynamometry
16 weeks
Tendon vascularity index as percentage at baseline
Tendon vascularity measured by power doppler ultrasonography
Before intervention
Change of tendon vascularity index as percentage at 12 weeks
Tendon vascularity measured by power doppler ultrasonography
12 weeks
Change of tendon vascularity index as percentage at 16 weeks
Tendon vascularity measured by power doppler ultrasonography
16 weeks
Secondary Outcomes (6)
Tendon related pain on visual analogy scale at baseline
Before intervention
Change of tendon related pain on visual analogy scale at 12 weeks
12 weeks
Change of tendon related pain on visual analogy scale at 16 weeks
16 weeks
Tendon related dysfunction by questionnaire at baseline
Before intervention
Change of tendon related dysfunction by questionnaire at 12 weeks
12 weeks
- +1 more secondary outcomes
Study Arms (2)
Combined
EXPERIMENTAL12 weeks eccentric exercise combined with 6 sessions of extracorporeal shockwave therapy in the initial 6 weeks
Exercise
SHAM COMPARATOR12 weeks eccentric exercise combined with 6 sessions of sham extracorporeal shockwave therapy in the initial 6 weeks
Interventions
Knee eccentric exercise with sham or focused extrocorporeal shockwave therapy for 12 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2020
First Posted
December 3, 2020
Study Start
February 16, 2011
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
December 3, 2020
Record last verified: 2011-02
Data Sharing
- IPD Sharing
- Will not share
No plan