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

• ClinicalTrials.gov Identifier: NCT04650997
• Recruitment Status: Completed
• First Posted: December 3, 2020
• Last Update Posted: December 3, 2020
• Sponsor: The Hong Kong Polytechnic University
• Information provided by (Responsible Party): The Hong Kong Polytechnic University

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.

Condition or disease	Intervention/treatment	Phase
Patellar Tendinopathy	Behavioral: Eccentric exercise	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Mechanical,Physiological and Therapeutic Effects of Eccentric Exercise Combined With Extracorporeal Shockwave Therapy in Athletes With Patellar Tendinopathy
• Actual Study Start Date: February 16, 2011
• Actual Primary Completion Date: January 1, 2014
• Actual Study Completion Date: January 1, 2014

Arms and Interventions

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 Name: 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 Name: Extracoporeal shockwave therapy (Minilith SL1, Storz Medical)

Outcome Measures

Primary Outcome Measures :

1. Tendon stress in pascals at baseline [ Time Frame: Before intervention ]
   Tendon stress measured by ultrasonography and dynamometry
2. Change of tendon stress in pascals at 12 weeks [ Time Frame: 12 weeks ]
   Tendon stress measured by ultrasonography and dynamometry
3. Change of tendon stress in pascals at 16 weeks [ Time Frame: 16 weeks ]
   Tendon stress measured by ultrasonography and dynamometry
4. Tendon vascularity index as percentage at baseline [ Time Frame: Before intervention ]
   Tendon vascularity measured by power doppler ultrasonography
5. Change of tendon vascularity index as percentage at 12 weeks [ Time Frame: 12 weeks ]
   Tendon vascularity measured by power doppler ultrasonography
6. Change of tendon vascularity index as percentage at 16 weeks [ Time Frame: 16 weeks ]
   Tendon vascularity measured by power doppler ultrasonography

Secondary Outcome Measures :

1. Tendon related pain on visual analogy scale at baseline [ Time Frame: Before intervention ]
   Maximal intensity of self-perceived pain in the past 7 days, pain during single-leg declined-squat test
2. Change of tendon related pain on visual analogy scale at 12 weeks [ Time Frame: 12 weeks ]
   Maximal intensity of self-perceived pain in the past 7 days, pain during single-leg declined-squat test
3. Change of tendon related pain on visual analogy scale at 16 weeks [ Time Frame: 16 weeks ]
   Maximal intensity of self-perceived pain in the past 7 days, pain during single-leg declined-squat test
4. Tendon related dysfunction by questionnaire at baseline [ Time Frame: Before intervention ]
   Victorian Institute of Sport Assessment Questionnaire - Patellar Tendon
5. Change of tendon related dysfunction by questionnaire at 12 weeks [ Time Frame: 12 weeks ]
   Victorian Institute of Sport Assessment Questionnaire - Patellar Tendon
6. Change of tendon related dysfunction by questionnaire at 16 weeks [ Time Frame: 16 weeks ]
   Victorian Institute of Sport Assessment Questionnaire - Patellar Tendon

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: The Hong Kong Polytechnic University
• ClinicalTrials.gov Identifier: NCT04650997
• Other Study ID Numbers: HSEARS20110215003
• First Posted: December 3, 2020
• Last Update Posted: December 3, 2020
• Last Verified: February 2011

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No plan

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

Additional relevant MeSH terms:

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries