NCT04650997

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
Last Updated

December 3, 2020

Status Verified

February 1, 2011

Enrollment Period

2.9 years

First QC Date

July 30, 2020

Last Update Submit

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

EXPERIMENTAL

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

Behavioral: Eccentric exercise

Exercise

SHAM COMPARATOR

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

Behavioral: Eccentric exercise

Interventions

Knee eccentric exercise with sham or focused extrocorporeal shockwave therapy for 12 weeks

Also known as: Extracoporeal shockwave therapy (Minilith SL1, Storz Medical)
CombinedExercise

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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