Shock Wave Threapy for Patellar TendinitisNCT07401758
Clinical Eficacy of Extracorporeal Shock Wave Therapy on Patellar Tendinitis
A study testing Extracorporeal Shock Wave Therapy on Patellar Tendon Combined with Center of Coordination Point and Extracorporeal Shock Wave Therapy only on Patellar Tendon in people with Shock Wave Threapy for Patellar Tendinitis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 2 sites in China.
Trial summary
This study is a randomized controlled trial. Patients diagnosed with patellar tendinitis and meeting the criteria for shockwave therapy were included. Relevant clinical data and assessments were collected upon enrollment and after obtaining informed consent. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Shock Wave Threapy for Patellar Tendinitis
- What is being tested?
- Extracorporeal Shock Wave Therapy on Patellar Tendon Combined with Center of Coordination Point and Extracorporeal Shock Wave Therapy only on Patellar Tendon
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesChina
- Study dates
- 1 Mar 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged between 18 and 45 yearsWillingness to sign an informed consent form and ability to cooperate with the treatment and follow-up aspects of this study.
- Meeting the diagnostic criteria for patellar tendinitis as outlined in "Practical Sports Medicine" (2023 edition)
- Knee joint pain with a VAS score of ≥3 and ≤7
- No other orthopedic or neurological conditions that could affect lower limb strength or mobility
- Willingness to sign an informed consent form and ability to cooperate with the treatment and follow-up aspects of this study
Who cannot join
- History of knee joint surgery within the past year
- Presence of knee pain due to other causes, or conditions that affect the knee joint or impact its function (including but not limited to: transient synovitis, bone tuberculosis, bone tumors, acute traumatic arthritis, suppurative arthritis, rheumatoid arthritis, metabolic bone diseases, psoriatic arthritis, gouty arthritis, bone necrosis, ankylosing spondylitis, or active infections)
- Presence of chronic knee pain caused by other reasons (such as post-herpetic neuralgia, osteoporosis, etc.)
- Contraindications for shockwave therapy, such as deep venous thrombosis in the lower extremities, bleeding disorders or coagulation dysfunction, pregnancy, cognitive dysfunction, etc.
- Presence of cancerous tumors, severe bronchiectasis, acute suppurative inflammation, high fever, active pulmonary tuberculosis, heart failure, severe anemia, cerebrovascular diseases, or the presence of a cardiac pacemaker implanted in the body
- Inability to participate in the trial due to other health issues, such as sudden severe trauma, sudden severe infectious diseases, etc.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
中山大学孙逸仙纪念医院
Guangzhou, Guangdong, 510000
松坚 柯, 学士, 86-020-81332732, songjian112626@163.com
- Recruiting
中山大学孙逸仙纪念医院
Guangzhou, Guangdong, 510000
松坚 ke, 学士, 86-020-81332732, songjian112626@163.com
About this study
Official title: Clinical Eficacy of Extracorporeal Shock Wave Therapy on Patellar Tendon Combined With Center of Coordination Point in the Fascial Manipulation for Patellar Tendinitis:A Randomized Controlled Trial.
This study is a randomized controlled trial. Patients diagnosed with patellar tendinitis and meeting the criteria for shockwave therapy were included. Relevant clinical data and assessments were collected upon enrollment and after obtaining informed consent. Randomization was performed using a random number table: the experimental and control groups. Based on the group assignments, the experimental group received either patellar tendon combined with fascial therapy coordinated centre point shock wave treatment, while the control group received only shockwave therapy for the patellar tendon. The treatments were performed by a rehabilitation therapist with extensive clinical experience. Data on participant pain and knee joint function were collected using the Visual Analogue Scale (VAS) and the Lysholm Knee Scoring System at baseline and on the day following completion of all treatments. Data on the thickness of the patellar tendon on the affected side of the knee were collected using a portable musculoskeletal ultrasound imaging system. Follow-up assessments and data collection on pain and knee joint function were conducted using the VAS and Lysholm Knee Scoring Scale one month and three months after the completion of all treatments to compare changes before and after treatment and to evaluate whether patellar tendon combined with fascial therapy coordinated centre point shock wave therapy has superior short-term and medium-term maintenance efficacy for patellar tendinitis compared with simple patellar tendon shock wave therapy.
- Being tested
- Extracorporeal Shock Wave Therapy on Patellar Tendon Combined with Center of Coordination Point, Extracorporeal Shock Wave Therapy only on Patellar Tendon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock Wave Therapy on Patellar Tendon Combined with Center of Coordination PointProcedure or surgery
Extracorporeal shockwave therapy was performed on the patellar tendon (Belgium Gymna Shock Master 500 Extracorporeal Shockwave Therapy Device) with a frequency of 8Hz and energy of 2.0Bar, for a total of 2000 shocks; shockwave therapy was performed at the coordination centre points marked after assessment by a fascia therapist (Belgium Gymna Shock Master 500 Extracorporeal Shockwave Therapy Device) with a frequency of 8Hz and energy of 2.0Bar, for a total of 4000 shocks. The patient underwent a total of 3 treatment courses, with an interval of 1 week between each course.
Extracorporeal Shock Wave Therapy only on Patellar TendonProcedure or surgery
Extracorporeal shockwave therapy was performed only on the patellar tendon (Belgium Gymna Shock Master 500 Extracorporeal Shockwave Therapy Device) with a frequency of 8Hz and energy of 2.0Bar, for a total of 6000 shocks.The patient underwent a total of 3 treatment courses, with an interval of 1 week between each course.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Extracorporeal shockwave therapy was performed not only on the patellar tendon but also at the coordination centre points marked after assessment by a fascia therapist . Receives: Procedure: Extracorporeal Shock Wave Therapy on Patellar Tendon Combined with Center of Coordination Point |
| Control Group | Active comparator | Extracorporeal shockwave therapy was performed only on the patellar tendon . Receives: Procedure: Extracorporeal Shock Wave Therapy only on Patellar Tendon |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in pain intensity over a follow-up period of 3 months after treatment
Determine the medium-term maintenance effect of pain relief before and after treatment. Use the Visual Analogue Scale (VAS) to quantitatively assess changes in pain intensity at the 3-month follow-up after treatment. At baseline and at 3 months after the completion of all treatments, the assessment is carried out using the Visual Analogue Scale by a trained therapist who is not involved in the intervention treatment or data analysis.
Measured: Baseline and Day 105
Secondary outcomes (3)
The changes in pain intensity measured both on the day following treatment and during the follow-up period of one month
Determine the early changes in the intensity of knee pain in patients: assessed at baseline, on the day all treatments were completed, and one month after all treatments were completed, using a visual analogue scale by a trained therapist not involved in the intervention treatment or data analysis.
Measured: Baseline, Day 15 and Day 45
the changes in the Lysholm knee scoring scale after treatment, as well as during follow-up visits after one and three months.
Changes in patient knee joint function: At baseline, on the day of completion of all treatments, and at 1 and 3 months after completion of all treatments, the function of the patient's affected knee joint was assessed by a trained therapist not involved in the intervention treatment or data analysis using the Lysholm Knee Scoring Scale.
Measured: Baseline, Day 15, Day 45 and Day 105
the change in the thickness of the patellar tendon on the day following treatment
Changes in the thickness of the patient's knee patellar tendon: At baseline and on the day after all treatments were completed, the thickness of the patellar tendon of the affected knee was assessed using a portable musculoskeletal ultrasound imaging system by a trained therapist who did not participate in the intervention treatment or data analysis.
Measured: Baseline and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shock Wave Threapy for Patellar TendinitisStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401758
- Sponsor's protocol ID
- SYSKY-2025-946-02
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Eficacy of Extracorporeal Shock Wave Therapy on Patellar Tendon Combined With Center of Coordination Point in the Fascial Manipulation for Patellar Tendinitis:A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07401758
- Acronym / sponsor ID
- SYSKY-2025-946-02
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Feb 2026 (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.
This study is a randomized controlled trial. Patients diagnosed with patellar tendinitis and meeting the criteria for shockwave therapy were included. Relevant clinical data and assessments were collected upon enrollment and after obtaining informed consent. Randomization was performed using a random number table: the experimental and control groups. Based on the group assignments, the experimental group received either patellar tendon combined with fascial therapy coordinated centre point shock wave treatment, while the control group received only shockwave therapy for the patellar tendon. The treatments were performed by a rehabilitation therapist with extensive clinical experience. Data on participant pain and knee joint function were collected using the Visual Analogue Scale (VAS) and the Lysholm Knee Scoring System at baseline and on the day following completion of all treatments. Data on the thickness of the patellar tendon on the affected side of the knee were collected using a portable musculoskeletal ultrasound imaging system. Follow-up assessments and data collection on pain and knee joint function were conducted using the VAS and Lysholm Knee Scoring Scale one month and three months after the completion of all treatments to compare changes before and after treatment and to evaluate whether patellar tendon combined with fascial therapy coordinated centre point shock wave therapy has superior short-term and medium-term maintenance efficacy for patellar tendinitis compared with simple patellar tendon shock wave therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Extracorporeal Shock Wave Therapy on Patellar Tendon Combined with Center of Coordination PointExtracorporeal shockwave therapy was performed not only on the patellar tendon but also at the coordination centre points marked after assessment by a fascia therapist . |
| Control Group | Active comparator | Procedure: Extracorporeal Shock Wave Therapy only on Patellar TendonExtracorporeal shockwave therapy was performed only on the patellar tendon . |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged between 18 and 45 yearsWillingness to sign an informed consent form and ability to cooperate with the treatment and follow-up aspects of this study.
- Meeting the diagnostic criteria for patellar tendinitis as outlined in "Practical Sports Medicine" (2023 edition)
- Knee joint pain with a VAS score of ≥3 and ≤7
- No other orthopedic or neurological conditions that could affect lower limb strength or mobility
- Willingness to sign an informed consent form and ability to cooperate with the treatment and follow-up aspects of this study
Key exclusion criteria (6 listed)
- History of knee joint surgery within the past year
- Presence of knee pain due to other causes, or conditions that affect the knee joint or impact its function (including but not limited to: transient synovitis, bone tuberculosis, bone tumors, acute traumatic arthritis, suppurative arthritis, rheumatoid arthritis, metabolic bone diseases, psoriatic arthritis, gouty arthritis, bone necrosis, ankylosing spondylitis, or active infections)
- Presence of chronic knee pain caused by other reasons (such as post-herpetic neuralgia, osteoporosis, etc.)
- Contraindications for shockwave therapy, such as deep venous thrombosis in the lower extremities, bleeding disorders or coagulation dysfunction, pregnancy, cognitive dysfunction, etc.
- Presence of cancerous tumors, severe bronchiectasis, acute suppurative inflammation, high fever, active pulmonary tuberculosis, heart failure, severe anemia, cerebrovascular diseases, or the presence of a cardiac pacemaker implanted in the body
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 |
|---|---|---|
| Extracorporeal Shock Wave Therapy on Patellar Tendon Combined with Center of Coordination PointExtracorporeal shockwave therapy was performed on the patellar tendon (Belgium Gymna Shock Master 500 Extracorporeal Shockwave Therapy Device) with a frequency of 8Hz and energy of 2.0Bar, for a total of 2000 shocks; shockwave therapy was performed at the coordination centre points marked after assessment by a fascia therapist (Belgium Gymna Shock Master 500 Extracorporeal Shockwave Therapy Device) with a frequency of 8Hz and energy of 2.0Bar, for a total of 4000 shocks. The patient underwent a total of 3 treatment courses, with an interval of 1 week between each course. | Procedure or surgery | Experimental Group |
| Extracorporeal Shock Wave Therapy only on Patellar TendonExtracorporeal shockwave therapy was performed only on the patellar tendon (Belgium Gymna Shock Master 500 Extracorporeal Shockwave Therapy Device) with a frequency of 8Hz and energy of 2.0Bar, for a total of 6000 shocks.The patient underwent a total of 3 treatment courses, with an interval of 1 week between each course. | Procedure or surgery | Control Group |
Primary outcome
the change in pain intensity over a follow-up period of 3 months after treatment
Time frame: Baseline and Day 105
Determine the medium-term maintenance effect of pain relief before and after treatment. Use the Visual Analogue Scale (VAS) to quantitatively assess changes in pain intensity at the 3-month follow-up after treatment. At baseline and at 3 months after the completion of all treatments, the assessment is carried out using the Visual Analogue Scale by a trained therapist who is not involved in the intervention treatment or data analysis.
3 secondary outcomes
The changes in pain intensity measured both on the day following treatment and during the follow-up period of one month
Time frame: Baseline, Day 15 and Day 45
the changes in the Lysholm knee scoring scale after treatment, as well as during follow-up visits after one and three months.
Time frame: Baseline, Day 15, Day 45 and Day 105
the change in the thickness of the patellar tendon on the day following treatment
Time frame: Baseline and Day 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock Wave Therapy on Patellar Tendon Combined with Center of Coordination Point and Extracorporeal Shock Wave Therapy only on Patellar Tendon in people with Shock Wave Threapy for Patellar Tendinitis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 2 sites in China.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact 松坚 ke, 学士 (86-020-81332732, songjian112626@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change in pain intensity over a follow-up period of 3 months after treatment (time frame: Baseline and Day 105). 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 10 Feb 2026.