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

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.

Study Overview

• Status: Completed
• Conditions: Patellar Tendinopathy
• Intervention / Treatment: Behavioral: Eccentric exercise

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Combined; 12 weeks eccentric exercise combined with 6 sessions of extracorporeal shockwave therapy in the initial 6 weeks	Behavioral: Eccentric exercise; Knee eccentric exercise with sham or focused extrocorporeal shockwave therapy for 12 weeks; Other Names: Extracoporeal shockwave therapy (Minilith SL1, Storz Medical)
SHAM_COMPARATOR: Exercise; 12 weeks eccentric exercise combined with 6 sessions of sham extracorporeal shockwave therapy in the initial 6 weeks	Behavioral: Eccentric exercise; Knee eccentric exercise with sham or focused extrocorporeal shockwave therapy for 12 weeks; Other Names: Extracoporeal shockwave therapy (Minilith SL1, Storz Medical)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Before intervention
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	12 weeks
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	16 weeks
Tendon related dysfunction by questionnaire at baseline	Victorian Institute of Sport Assessment Questionnaire - Patellar Tendon	Before intervention
Change of tendon related dysfunction by questionnaire at 12 weeks	Victorian Institute of Sport Assessment Questionnaire - Patellar Tendon	12 weeks
Change of tendon related dysfunction by questionnaire at 16 weeks	Victorian Institute of Sport Assessment Questionnaire - Patellar Tendon	16 weeks

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 16, 2011
• Primary Completion (ACTUAL): January 1, 2014
• Study Completion (ACTUAL): January 1, 2014

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (ACTUAL): December 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 3, 2020
• Last Update Submitted That Met QC Criteria: November 25, 2020
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: HSEARS20110215003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No