Rotator Cuff InjuriesNCT04848103
Effect of Extracorporeal Shock Wave Therapy After Arthroscopic Rotator Cuff Repair
A study testing Radial extracorporeal shockwave therapy in people with Rotator Cuff Injuries and Pain, Postoperative, run by Sahmyook University at 1 site in South Korea.
Trial summary
Although radial extracorporeal shock wave therapy (rESWT) has proven to be an effective treatment, the effectiveness of the treatment has so far been controversial. There are no studies using rESWT in rehabilitation after arthroscopic rotator cuff repair (ARCR). Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Rotator Cuff Injuries, Pain, Postoperative, Tissue Adhesion
- What is being tested?
- Radial extracorporeal shockwave therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 May 2021to 8 Jul 2021
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 18 years old
- In case of 6 weeks after receiving arthroscopic rotator cuff repair
- When the participants wishes to enroll in the study
Who cannot join
- 65 years old or older
- If the tear area is large and augmentation is performed
- If there is a previous surgical history at the surgical site
- Osteoarthritis in the shoulder joint
Trial locations and contacts
1 site in 1 country.
About this study
Although radial extracorporeal shock wave therapy (rESWT) has proven to be an effective treatment, the effectiveness of the treatment has so far been controversial. There are no studies using rESWT in rehabilitation after arthroscopic rotator cuff repair (ARCR). Therefore, in this study, there is evidence that rESWT promotes pain control and healing recovery, and through previous studies, we would like to investigate whether treatment with rESWT during the intensive rehabilitation period of patients after ARCR is more effective in controlling pain.
- Conditions
- Rotator Cuff Injuries, Pain, Postoperative, Tissue Adhesion
- Being tested
- Radial extracorporeal shockwave therapy
- Medical subject headings
- Rotator Cuff Injuries, Pain, Postoperative, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial extracorporeal shockwave therapyBehavioural
Radial extracorporeal shockwave therapy group include Therapeutic modality(Transcutaneous electrical nerve stimulation [TENS], Microwave thermotherapy, and Superficial heat therapy), Range of motion exercise(Continuous passive motion and Active range of motion exercise).
| Study group | Role | What they receive |
|---|---|---|
| Radial extracorporeal shockwave therapy | Experimental | Not described Receives: Behavioral: Radial extracorporeal shockwave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
. Pain intensity
A numeric pain rating scale (NPRS) consisting of 11 points in total from 0 points (no pain) to 10 points (the most severe pain imaginable) is used. The lower the score, the less the pain.
Measured: Change from baseline pain intensity at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start10 May 2021
- Primary completion30 Jun 2021
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahmyook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun-Joong Kim, Sahmyook University
- Investigators
- Hyun-Joong Kim, MSc, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848103
- Sponsor's protocol ID
- 2-1040781-A-N-012021035HR
- Status last verified
- Jul 2021
- First submitted
- 13 Apr 2021
- Last updated
- 13 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim HJ, Choi W, Jung J, Park S, Joo Y, Lee S, Lee S. Efficacy of radial extracorporeal shockwave therapy in rehabilitation following arthroscopic rotator cuff repair: A STROBE compliant study. Medicine (Baltimore). 2022 Sep 2;101(35):e30053. doi: 10.1097/MD.0000000000030053.
PubMed 36107497
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extracorporeal Shock Wave Therapy After Arthroscopic Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT04848103
- Acronym / sponsor ID
- 2-1040781-A-N-012021035HR
- Conditions
- Rotator Cuff Injuries, Pain, Postoperative, Tissue Adhesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sahmyook UniversityUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 19 Apr 2021 (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.
Although radial extracorporeal shock wave therapy (rESWT) has proven to be an effective treatment, the effectiveness of the treatment has so far been controversial. There are no studies using rESWT in rehabilitation after arthroscopic rotator cuff repair (ARCR). Therefore, in this study, there is evidence that rESWT promotes pain control and healing recovery, and through previous studies, we would like to investigate whether treatment with rESWT during the intensive rehabilitation period of patients after ARCR is more effective in controlling pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radial extracorporeal shockwave therapy | Experimental | Behavioral: Radial extracorporeal shockwave therapy |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults over 18 years old
- In case of 6 weeks after receiving arthroscopic rotator cuff repair
- When the participants wishes to enroll in the study
Key exclusion criteria (4 listed)
- 65 years old or older
- If the tear area is large and augmentation is performed
- If there is a previous surgical history at the surgical site
- Osteoarthritis in the shoulder joint
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 |
|---|---|---|
| Radial extracorporeal shockwave therapyRadial extracorporeal shockwave therapy group include Therapeutic modality(Transcutaneous electrical nerve stimulation [TENS], Microwave thermotherapy, and Superficial heat therapy), Range of motion exercise(Continuous passive motion and Active range of motion exercise). | Behavioural | Radial extracorporeal shockwave therapy |
Primary outcome
. Pain intensity
Time frame: Change from baseline pain intensity at 2 weeks
A numeric pain rating scale (NPRS) consisting of 11 points in total from 0 points (no pain) to 10 points (the most severe pain imaginable) is used. The lower the score, the less the pain.
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 13 Jul 2021.
- Derived from this study: PubMed 36107497Kim HJ, Choi W, Jung J, Park S, Joo Y, Lee S, Lee S. Efficacy of radial extracorporeal shockwave therapy in rehabilitation following arthroscopic rotator cuff repair: A STROBE compliant study. Medicine (Baltimore). 2022 Sep 2;101(35):e30053. doi: 10.1097/MD.0000000000030053.
- Individual participant dataSharing planned: No
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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.
Hyun-Joong Kim, MSc principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial extracorporeal shockwave therapy in people with Rotator Cuff Injuries and Pain, Postoperative, run by Sahmyook University at 1 site in South Korea.
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 13 Jul 2021. 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 South Korea. 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?
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?
. Pain intensity (time frame: Change from baseline pain intensity at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04848103, which also lists 1 linked publication.
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 13 Jul 2021.