Elbow Osteochondritis DissecansNCT07884578
The Effectiveness of Extracorporeal Shock Wave Therapy for Elbow Osteochondritis Dissecans (OCD)
A study testing Extracorporeal Shock Wave Therapy and Extracorporeal Shock Wave Therapy(no-energy) in people with Elbow Osteochondritis Dissecans, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Extracorporeal shock wave therapy was performed on athletes aged 15-18 years with lateral maxillary chondritis of the elbow, and X-ray, blood tests, and MRI were conducted to evaluate the treatment progress. Read more about this study
- Who is it for?
- Ages 15 to 18 years
- Conditions the study is for
- Elbow Osteochondritis Dissecans
- What is being tested?
- Extracorporeal Shock Wave Therapy and Extracorporeal Shock Wave Therapy(no-energy)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Feb 2020to 31 Jul 2022
- 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 15 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Confirmed by magnetic resonance imaging (MRI) or X-ray of osteochondritis of the lateral epicondyle of the elbow.
- Athletes aged 15-18 years with partial or complete fusion of the growth plate.
- Ineffective conservative treatment after 3 months.
Who cannot join
- Osteochondritis of the lateral epicondyle has entered the fragmentation stage.
- Elbow range of motion is limited to more than 20 degrees.
- The growth plate remains open.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Extracorporeal Shockwave Therapy for Humeral Capitellum Osteochondritis Dissecans of the Throwing Elbow
Extracorporeal shock wave therapy was performed on athletes aged 15-18 years with lateral maxillary chondritis of the elbow, and X-ray, blood tests, and MRI were conducted to evaluate the treatment progress.
Read the detailed description
- Phase 1: 52 patients were enrolled and randomly assigned to an experimental group and a control group. Under general anesthesia, the location of the osteochondritis dissociation in the humeral capitula was first located using fluoroscopy. Extracorporeal shock wave therapy (Storz) was then applied to the osteochondritis dissociation in the humeral capitula. The energy was randomly selected, with patients receiving 3000 impulses at 28kV. Postoperatively, the elbow joint was protected with a brace, and any weight-bearing movement or activity of the elbow joint was prohibited. The control group received Shame therapy, with the elbow joint protected with a brace, and any weight-bearing movement or activity of the elbow joint was prohibited. The recovery status of the osteochondritis dissociation in both groups was followed up at 1, 3, 6, and 12 months postoperatively.
- Phase 2: Ten more patients were enrolled to compare the clinical differences between one and two shock wave treatments. Patients were randomly assigned to an experimental group and a control group. Under general anesthesia, the location of osteochondritis dissociation in the humeral capitula was first located using fluoroscopy. Then, extracorporeal shock wave therapy (Storz) was applied to the osteochondritis dissociation in the humeral capitula, with the energy selected randomly at 3000 impulses at 28kV. Postoperatively, the elbow joint was protected with a brace, and any weight-bearing movement or activity of the elbow joint was prohibited. The experimental group received a second shock wave therapy 3 months after the first treatment, with the elbow joint protected with a brace, and any weight-bearing movement or activity of the elbow joint was prohibited. The recovery status of osteochondritis dissociation in both groups was followed up at 1, 3, 6, and 12 months postoperatively.
- Conditions
- Elbow Osteochondritis Dissecans
- Being tested
- Extracorporeal Shock Wave Therapy, Extracorporeal Shock Wave Therapy(no-energy)
- Keywords
- OCD, Osteochondritis dissecans, ESWT, Extracorporeal Shock Wave Therapy, Elbow OCD
- Medical subject headings
- Osteochondritis Dissecans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock Wave TherapyDevice
Extracorporeal shock wave therapy (Storz) was used on osteochondritis dissociated at the humeral capitula, 3000 impulses at 28kV.
Extracorporeal Shock Wave Therapy(no-energy)Device
Only the sound of shock waves, no energy.
| Study group | Role | What they receive |
|---|---|---|
| no-energy shock wave | Placebo comparator | Only the sound of shock waves, no energy Receives: Device: Extracorporeal Shock Wave Therapy(no-energy) |
| ESWT | Experimental | Extracorporeal shock wave therapy (Storz) was used on osteochondritis dissociated at the humeral capitula,
3000 impulses at 28kV. Receives: Device: Extracorporeal Shock Wave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Visual Analogue Scale (VAS)
The Visual Analogue Scale (VAS) is a tool commonly used to quantitatively assess the intensity of pain in patients. The two ends are labeled: • Left end (0 points): Represents "no pain at all". • Right end (10 points or 100 millimeters): Represents "the most intense pain imaginable".
Measured: Baseline and 1、 3、 6、 12、 18 months.
Mayo Elbow Performance Score( MEPS)
The Mayo Elbow Performance Score (MEPS) is a professional assessment tool widely used clinically to evaluate functional recovery after elbow fractures, arthritis, total joint replacement, or surgery.
The scale has a total score of 100 points, with higher scores indicating better elbow function. The scale mainly includes four assessment dimensions: Pain (maximum 45 points), Range of Motion (ROM) (maximum 20 points), Stability (maximum 10 points), and Daily Function (maximum 25 points).
Measured: Baseline and 1、 3、 6、 12、 18 months
Magnetic Resonance Imaging (MRI)
Magnetic resonance imaging (MRI) is a medical examination technique that uses a strong magnetic field and radio waves to induce resonance in hydrogen atoms within the body without ionizing radiation, and then reconstructs high-resolution 3D cross-sectional images using a computer.
MRI images are used to perform Nelson classification to assess the degree of damage and recovery stability of articular cartilage and subchondral bone in osteochondritis dissecans (OCD).
Measured: Baseline and 12 months
Elbow ROM (Elbow Range of Motion)(flexion)
Elbow ROM refers to the maximum angle and range of motion of the elbow joint under normal conditions in different directions.
Flexion: The movement of bending the elbow and bringing the palm closer to the shoulder. The normal angle is approximately 0° to 140°~150°.
Measured: Baseline and 1、 3、 6、 12、 18 months.
Elbow Range of Motion(Elbow ROM) (extension)
Elbow ROM refers to the maximum angle and range of motion of the elbow joint under normal conditions in different directions.
Extension: The movement of straightening the elbow. The normal angle is 0° (some people may naturally have a slight hyperextension of 5°~10°).
Measured: Baseline and 1、 3、 6、 12、 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start12 Feb 2020
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow Osteochondritis DissecansStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Model description
- The experiment was randomly divided into two groups: a no-energy shock wave group (control group) and a shock wave therapy group (experimental group). Both groups used braces or supports after treatment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884578
- Sponsor's protocol ID
- 201900490A3
- Other IDs
- CRRPG8J0042
- Status last verified
- Sep 2026
- First submitted
- 5 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient Personal Information and Regulatory Restrictions
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Extracorporeal Shockwave Therapy for Humeral Capitellum Osteochondritis Dissecans of the Throwing Elbow
- ClinicalTrials.gov ID
- NCT07884578
- Acronym / sponsor ID
- 201900490A3
- Conditions
- Elbow Osteochondritis Dissecans
- Keywords
- OCD, Osteochondritis dissecans, ESWT, Extracorporeal Shock Wave Therapy, Elbow OCD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 20 Oct 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.
Extracorporeal shock wave therapy was performed on athletes aged 15-18 years with lateral maxillary chondritis of the elbow, and X-ray, blood tests, and MRI were conducted to evaluate the treatment progress.
Detailed description
- Phase 1: 52 patients were enrolled and randomly assigned to an experimental group and a control group. Under general anesthesia, the location of the osteochondritis dissociation in the humeral capitula was first located using fluoroscopy. Extracorporeal shock wave therapy (Storz) was then applied to the osteochondritis dissociation in the humeral capitula. The energy was randomly selected, with patients receiving 3000 impulses at 28kV. Postoperatively, the elbow joint was protected with a brace, and any weight-bearing movement or activity of the elbow joint was prohibited. The control group received Shame therapy, with the elbow joint protected with a brace, and any weight-bearing movement or activity of the elbow joint was prohibited. The recovery status of the osteochondritis dissociation in both groups was followed up at 1, 3, 6, and 12 months postoperatively.
- Phase 2: Ten more patients were enrolled to compare the clinical differences between one and two shock wave treatments. Patients were randomly assigned to an experimental group and a control group. Under general anesthesia, the location of osteochondritis dissociation in the humeral capitula was first located using fluoroscopy. Then, extracorporeal shock wave therapy (Storz) was applied to the osteochondritis dissociation in the humeral capitula, with the energy selected randomly at 3000 impulses at 28kV. Postoperatively, the elbow joint was protected with a brace, and any weight-bearing movement or activity of the elbow joint was prohibited. The experimental group received a second shock wave therapy 3 months after the first treatment, with the elbow joint protected with a brace, and any weight-bearing movement or activity of the elbow joint was prohibited. The recovery status of osteochondritis dissociation in both groups was followed up at 1, 3, 6, and 12 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The experiment was randomly divided into two groups: a no-energy shock wave group (control group) and a shock wave therapy group (experimental group). Both groups used braces or supports after treatment.
| Arm | Type | Receives |
|---|---|---|
| no-energy shock wave | Placebo comparator | Device: Extracorporeal Shock Wave Therapy(no-energy)Only the sound of shock waves, no energy |
| ESWT | Experimental | Device: Extracorporeal Shock Wave TherapyExtracorporeal shock wave therapy (Storz) was used on osteochondritis dissociated at the humeral capitula, 3000 impulses at 28kV. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Confirmed by magnetic resonance imaging (MRI) or X-ray of osteochondritis of the lateral epicondyle of the elbow.
- Athletes aged 15-18 years with partial or complete fusion of the growth plate.
- Ineffective conservative treatment after 3 months.
Key exclusion criteria (3 listed)
- Osteochondritis of the lateral epicondyle has entered the fragmentation stage.
- Elbow range of motion is limited to more than 20 degrees.
- The growth plate remains open.
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 TherapyExtracorporeal shock wave therapy (Storz) was used on osteochondritis dissociated at the humeral capitula, 3000 impulses at 28kV. | Device | ESWT |
| Extracorporeal Shock Wave Therapy(no-energy)Only the sound of shock waves, no energy. | Device | no-energy shock wave |
Primary outcome
The Visual Analogue Scale (VAS)
Time frame: Baseline and 1、 3、 6、 12、 18 months.
The Visual Analogue Scale (VAS) is a tool commonly used to quantitatively assess the intensity of pain in patients. The two ends are labeled: • Left end (0 points): Represents "no pain at all". • Right end (10 points or 100 millimeters): Represents "the most intense pain imaginable".
Mayo Elbow Performance Score( MEPS)
Time frame: Baseline and 1、 3、 6、 12、 18 months
The Mayo Elbow Performance Score (MEPS) is a professional assessment tool widely used clinically to evaluate functional recovery after elbow fractures, arthritis, total joint replacement, or surgery. The scale has a total score of 100 points, with higher scores indicating better elbow function. The scale mainly includes four assessment dimensions: Pain (maximum 45 points), Range of Motion (ROM) (maximum 20 points), Stability (maximum 10 points), and Daily Function (maximum 25 points).
Magnetic Resonance Imaging (MRI)
Time frame: Baseline and 12 months
Magnetic resonance imaging (MRI) is a medical examination technique that uses a strong magnetic field and radio waves to induce resonance in hydrogen atoms within the body without ionizing radiation, and then reconstructs high-resolution 3D cross-sectional images using a computer. MRI images are used to perform Nelson classification to assess the degree of damage and recovery stability of articular cartilage and subchondral bone in osteochondritis dissecans (OCD).
Elbow ROM (Elbow Range of Motion)(flexion)
Time frame: Baseline and 1、 3、 6、 12、 18 months.
Elbow ROM refers to the maximum angle and range of motion of the elbow joint under normal conditions in different directions. Flexion: The movement of bending the elbow and bringing the palm closer to the shoulder. The normal angle is approximately 0° to 140°~150°.
Elbow Range of Motion(Elbow ROM) (extension)
Time frame: Baseline and 1、 3、 6、 12、 18 months.
Elbow ROM refers to the maximum angle and range of motion of the elbow joint under normal conditions in different directions. Extension: The movement of straightening the elbow. The normal angle is 0° (some people may naturally have a slight hyperextension of 5°~10°).
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 21 Oct 2026.
- Individual participant dataSharing planned: No. Patient Personal Information and Regulatory Restrictions
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.
1 site 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 and Extracorporeal Shock Wave Therapy(no-energy) in people with Elbow Osteochondritis Dissecans, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 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 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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. 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?
The Visual Analogue Scale (VAS) (time frame: Baseline and 1、 3、 6、 12、 18 months.). The study lists 5 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 21 Oct 2026.