Patellar TendinopathyNCT04650997
The Mechanical,Physiological and Therapeutic Effects of Eccentric Exercise Combined With Extracorporeal Shockwave Therapy in Athletes With Patellar Tendinopathy
A study testing Eccentric exercise in people with Patellar Tendinopathy, run by The Hong Kong Polytechnic University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patellar Tendinopathy
- What is being tested?
- Eccentric exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 16 Feb 2011to 1 Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Conditions
- Patellar Tendinopathy
- Being tested
- Eccentric exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric exerciseBehavioural
Also called Extracoporeal shockwave therapy (Minilith SL1, Storz Medical)
Knee eccentric exercise with sham or focused extrocorporeal shockwave therapy for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Combined | Experimental | 12 weeks eccentric exercise combined with 6 sessions of extracorporeal shockwave therapy in the initial 6 weeks Receives: Behavioral: Eccentric exercise |
| Exercise | Sham comparator | 12 weeks eccentric exercise combined with 6 sessions of sham extracorporeal shockwave therapy in the initial 6 weeks Receives: Behavioral: Eccentric exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tendon stress in pascals at baseline
Tendon stress measured by ultrasonography and dynamometry
Measured: Before intervention
Change of tendon stress in pascals at 12 weeks
Tendon stress measured by ultrasonography and dynamometry
Measured: 12 weeks
Change of tendon stress in pascals at 16 weeks
Tendon stress measured by ultrasonography and dynamometry
Measured: 16 weeks
Tendon vascularity index as percentage at baseline
Tendon vascularity measured by power doppler ultrasonography
Measured: Before intervention
Change of tendon vascularity index as percentage at 12 weeks
Tendon vascularity measured by power doppler ultrasonography
Measured: 12 weeks
Change of tendon vascularity index as percentage at 16 weeks
Tendon vascularity measured by power doppler ultrasonography
Measured: 16 weeks
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 16 weeks
Tendon related dysfunction by questionnaire at baseline
Victorian Institute of Sport Assessment Questionnaire - Patellar Tendon
Measured: Before intervention
Change of tendon related dysfunction by questionnaire at 12 weeks
Victorian Institute of Sport Assessment Questionnaire - Patellar Tendon
Measured: 12 weeks
Change of tendon related dysfunction by questionnaire at 16 weeks
Victorian Institute of Sport Assessment Questionnaire - Patellar Tendon
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start16 Feb 2011
- Primary completion1 Jan 2014
- Study completion1 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellar TendinopathyStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650997
- Sponsor's protocol ID
- HSEARS20110215003
- Status last verified
- Feb 2011
- First submitted
- 30 Jul 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mechanical,Physiological and Therapeutic Effects of Eccentric Exercise Combined With Extracorporeal Shockwave Therapy in Athletes With Patellar Tendinopathy
- ClinicalTrials.gov ID
- NCT04650997
- Acronym / sponsor ID
- HSEARS20110215003
- Conditions
- Patellar Tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 16 Feb 2011 (actual)
- Primary completion
- 1 Jan 2014 (actual)
- Study completion
- 1 Jan 2014 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined | Experimental | Behavioral: Eccentric exercise12 weeks eccentric exercise combined with 6 sessions of extracorporeal shockwave therapy in the initial 6 weeks |
| Exercise | Sham comparator | Behavioral: Eccentric exercise12 weeks eccentric exercise combined with 6 sessions of sham extracorporeal shockwave therapy in the initial 6 weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eccentric exerciseAlso: Extracoporeal shockwave therapy (Minilith SL1, Storz Medical)Knee eccentric exercise with sham or focused extrocorporeal shockwave therapy for 12 weeks | Behavioural | Combined, Exercise |
Primary outcome
Tendon stress in pascals at baseline
Time frame: Before intervention
Tendon stress measured by ultrasonography and dynamometry
Change of tendon stress in pascals at 12 weeks
Time frame: 12 weeks
Tendon stress measured by ultrasonography and dynamometry
Change of tendon stress in pascals at 16 weeks
Time frame: 16 weeks
Tendon stress measured by ultrasonography and dynamometry
Tendon vascularity index as percentage at baseline
Time frame: Before intervention
Tendon vascularity measured by power doppler ultrasonography
Change of tendon vascularity index as percentage at 12 weeks
Time frame: 12 weeks
Tendon vascularity measured by power doppler ultrasonography
Change of tendon vascularity index as percentage at 16 weeks
Time frame: 16 weeks
Tendon vascularity measured by power doppler ultrasonography
6 secondary outcomes
Tendon related pain on visual analogy scale at baseline
Time frame: Before intervention
Change of tendon related pain on visual analogy scale at 12 weeks
Time frame: 12 weeks
Change of tendon related pain on visual analogy scale at 16 weeks
Time frame: 16 weeks
Tendon related dysfunction by questionnaire at baseline
Time frame: Before intervention
Change of tendon related dysfunction by questionnaire at 12 weeks
Time frame: 12 weeks
Change of tendon related dysfunction by questionnaire at 16 weeks
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Individual participant dataSharing planned: No. No plan
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Chronic Patellar Tendinopathy (PT)is Prevalent in Participants of Several Sports.A Three-arm, Single-blind Randomized Controlled Trial Will be Conducted. We Want to Compare the Clinical Effectiveness of ESWT Alone, ESWT Combined With Hyaluronic Acid, and ESWT Combined With PRP in Athletes With PT
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric exercise in people with Patellar Tendinopathy, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tendon stress in pascals at baseline (time frame: Before intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.