Rotator Cuff InjuriesNCT06329154
Clinical Study On Extracorporeal Shock Wave Therapy For Rotator Cuff Injuries
A study testing Extracorporeal shock wave therapy and conventional rehabilitation therapy in people with Rotator Cuff Injuries, run by Yong Liu, MD at 1 site in China.
Trial summary
This clinical trial aims to learn about the effect of extracorporeal shock wave therapy on rotator cuff injuries. The main question it aims to answer is the efficacy of extracorporeal shock wave therapy on the improvement of pain, shoulder function, and quality of life in patients with rotator cuff injuries. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Rotator Cuff Injuries
- What is being tested?
- Extracorporeal shock wave therapy and conventional rehabilitation therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2024to 27 Feb 2025
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria of rotator cuff injuries in 2019 American Academy of Orthopaedic Surgeons Clinical Practice Guideline for rotator Cuff Injuries (diagnostic criteria: （1）The clinical signs included positive empty cup test and full cup test, positive internal rotation resistance test in abduction and external rotation position and positive Jobe sign in lateral position. (2) Imaging: magnetic resonance imaging, magnetic resonance arthrography or ultrasound showed rotator cuff injuries, including supraspinatus, infraspinatus, teres minor and subscapularis tendon injuries);
- Definite imaging diagnosis: magnetic resonance imaging, magnetic resonance arthrography or ultrasound examination;
- The shoulder joint did not receive surgical treatment;
- Both sexes, aged 20-80 years old;
- Stable vital signs, good communication, and active cooperation to complete the relevant evaluation and treatment;
- Informed consent was obtained from patients or their families before treatment.
Who cannot join
- MRI showed medium, large and huge full-thickness rotator cuff tears;
- Skin damage or skin disease at the application site;
- Previous history of shoulder surgery;
- Pregnant or lactating women;
- Allergic constitution;
- Patients with primary diseases of the heart, liver, kidney, or hematopoietic system, patients with mental disorders, patients with built-in cardiac pacemaker, and patients with implanted metal medical devices;
- complicated with other diseases that cause body pain;
- Unable to cooperate with the completion of the whole treatment and follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
yong liu, 18098876656, fuwa52008@126.com
About this study
This clinical trial aims to learn about the effect of extracorporeal shock wave therapy on rotator cuff injuries. The main question it aims to answer is the efficacy of extracorporeal shock wave therapy on the improvement of pain, shoulder function, and quality of life in patients with rotator cuff injuries. The experimental group of patients received extracorporeal shock wave therapy combined with conventional rehabilitation therapy. The control group only received conventional rehabilitation therapy. Compare the two groups to explore the therapeutic effect of extracorporeal shock wave therapy on rotator cuff injuries.
- Conditions
- Rotator Cuff Injuries
- Being tested
- Extracorporeal shock wave therapy, conventional rehabilitation therapy
- Keywords
- Rotator Cuff Injuries, Extracorporeal Shockwave Therapy
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shock wave therapyDevice
The experimental group received extracorporeal shock wave therapy combined with conventional rehabilitation therapy. The control group was only given conventional rehabilitation therapy. According to the patient's tolerance and the specific condition, extracorporeal shock wave therapy was performed twice a week, 2000-3000 times each time, energy parameters of 2.5-3.5Bar, 8-15Hz, treatment interval > 1 day, consecutive 4 weeks. Conventional rehabilitation therapy included medium frequency electricity, ultrasound, ultrashort wave, laser and wax therapy. Routine rehabilitation was given once a day, 5 times a week for 4 weeks.
conventional rehabilitation therapyOther
Conventional rehabilitation therapy included medium frequency electricity, ultrasound, ultrashort wave, laser, and wax therapy (same as the control group). Routine rehabilitation was given once a day, 5 times a week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| extracorporeal shock wave therapy group | Experimental | The experimental group received extracorporeal shock wave therapy combined with conventional rehabilitation therapy. Conventional rehabilitation therapy includes medium frequency electricity, ultrasound, ultrashort wave, laser, wax therapy, etc. Receives: Device: Extracorporeal shock wave therapy |
| control group | Active comparator | The control group received conventional rehabilitation therapy. Conventional rehabilitation therapy includes medium frequency electricity, ultrasound, ultrashort wave, laser, wax therapy, etc. Receives: Other: conventional rehabilitation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Visual Analogue Scale at 4 weeks
Visual analogue Scale is the most commonly used single-dimensional measurement of pain intensity. The scale mainly consists of a 10-cm straight line, one end of which indicates "no pain at all" and the other end indicates "the most severe pain imaginable" or "pain to the extreme" etc. The patient will be asked to mark the corresponding position on this line to represent the intensity of the pain they feel at that time.
Measured: baseline and 4 weeks
Change from Baseline Range of Motion at 4 weeks
The range of motion of the shoulder joint refers to the active and passive range of motion of the shoulder joint measured with a protractor, including forward flexion, back extension, abduction, internal rotation, and external rotation.
Measured: baseline and 4 weeks
Change from Baseline Constant-Murley Score at 4 weeks
Constant-Murley Score is the unified shoulder score of the European Society for Shoulder and Elbow Surgery. The left and right shoulder joints were scored separately. It mainly includes 8 aspects of shoulder joint-related problems: 1, pain; 2. Degree of influence on daily life; 3. The hand can lift the height that can be reached; 4. Upper limb abduction muscle strength; 5. The degree of upper limb forward lifting; 6, the degree of upper limb abduction; 7. The degree of external rotation of the upper limbs; 8, the degree of internal rotation of the upper limb can be achieved.
Measured: baseline and 4 weeks
Change from Baseline Isokinetic muscle strength testing at 4 weeks
Isokinetic muscle testing can be used for quantitative measurement of muscle strength, and the evaluation results have objectivity, accuracy, repeatability, and high sensitivity.
Measured: baseline and 4 weeks
Change from Baseline Magnetic resonance imaging at 4 weeks
Magnetic resonance imaging has good soft tissue resolution and can clearly show the injuries of tendons and ligaments around the shoulder joint. It is one of the main examination methods for the evaluation of rotator cuff injuries.
Measured: baseline and 4 weeks
Change from Baseline Musculoskeletal ultrasound at 4 weeks
Musculoskeletal ultrasound uses high-frequency ultrasound to diagnose musculoskeletal diseases, which can clearly show the superficial soft tissue structures such as muscles, tendons, ligaments, peripheral nerves, and their lesions. It is one of the main examination methods for the evaluation of rotator cuff injuries.
Measured: baseline and 4 weeks
Secondary outcomes (5)
Change from Baseline American Shoulder and Elbow Surgeons Score at 4 weeks
Developed by the American Society of Shoulder and Elbow Surgeons, it measures shoulder pain, function, or disability. The pain and function subscales each account for 50 points, and the total score ranges from 0 to 100, with higher scores indicating better conditions, i.e. less severe symptoms; The lower the score, the more severe the disease. The assessment consisted of 1 item for pain and 10 items for function.
Measured: baseline and 4 weeks
Change from Baseline Shoulder Pain and Disability Index at 4 weeks
The Shoulder Pain and Disability Index measures the pain and disability associated with shoulder lesions. It consists of two subscales: pain and functional or disability. The total score is converted to a score of 0 to 100, with higher scores indicating greater pain and disability.
Measured: baseline and 4 weeks
Change from Baseline Disability of the Arm, Shoulder and Hand Score at 4 weeks
The Disability of the Arm, Shoulder, and Hand Score was developed by the American Academy of Orthopaedic Surgeons and the Institute for Work and Health to measure the level of upper extremity-related symptoms, function, or disability. There were 30 items: 5 symptom related and 25 function related. The total score is converted to a 0-100 percentage, with higher scores indicating greater disability. Another two subscales can be selected: work and exercise.
Measured: baseline and 4 weeks
Change from Baseline University of California at Los Angeles Shoulder Scale at 4 weeks
The University of California at Los Angeles Shoulder Scale was developed by Dr. Amstutz and colleagues at the University of California at Los Angeles Shoulder Scale. Pain, function, active forward flexion, strength of forward flexion, and total satisfaction. The total score ranges from 0 to 35, and some studies will convert the score into a score of 0 to 100, with higher scores indicating better conditions.
Measured: baseline and 4 weeks
Change from Baseline Pittsburgh sleep quality index at 4 weeks
The Pittsburgh sleep quality index was developed by Dr. Buysse, a psychiatrist at the University of Pittsburgh in 1989. It was used to assess the sleep quality of the subjects in the last month. It consisted of 19 self-rated items and 5 other-rated items, of which the 19th self-rated item and 5 other-rated items were not involved in the scoring. The total score of each component was the total score. The total score ranged from 0 to 21, and the higher the score, the worse the sleep quality.
Measured: baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start27 Feb 2024
- Primary completion27 Jan 2025 (estimated)
- Study completion27 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yong Liu, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yong Liu, MD, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329154
- Sponsor's protocol ID
- PJ-KS-KY-2024-03(X)
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study On Extracorporeal Shock Wave Therapy For Rotator Cuff Injuries
- ClinicalTrials.gov ID
- NCT06329154
- Acronym / sponsor ID
- PJ-KS-KY-2024-03(X)
- Conditions
- Rotator Cuff Injuries
- Keywords
- Rotator Cuff Injuries, Extracorporeal Shockwave Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Yong Liu, MDUniversity, hospital or other
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 27 Jan 2025 (estimated)
- Study completion
- 27 Feb 2025 (estimated)
- First posted
- 25 Mar 2024 (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 clinical trial aims to learn about the effect of extracorporeal shock wave therapy on rotator cuff injuries. The main question it aims to answer is the efficacy of extracorporeal shock wave therapy on the improvement of pain, shoulder function, and quality of life in patients with rotator cuff injuries. The experimental group of patients received extracorporeal shock wave therapy combined with conventional rehabilitation therapy. The control group only received conventional rehabilitation therapy. Compare the two groups to explore the therapeutic effect of extracorporeal shock wave therapy on rotator cuff injuries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extracorporeal shock wave therapy group | Experimental | Device: Extracorporeal shock wave therapyThe experimental group received extracorporeal shock wave therapy combined with conventional rehabilitation therapy. Conventional rehabilitation therapy includes medium frequency electricity, ultrasound, ultrashort wave, laser, wax therapy, etc. |
| control group | Active comparator | Other: conventional rehabilitation therapyThe control group received conventional rehabilitation therapy. Conventional rehabilitation therapy includes medium frequency electricity, ultrasound, ultrashort wave, laser, wax therapy, etc. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meet the diagnostic criteria of rotator cuff injuries in 2019 American Academy of Orthopaedic Surgeons Clinical Practice Guideline for rotator Cuff Injuries (diagnostic criteria: （1）The clinical signs included positive empty cup test and full cup test, positive internal rotation resistance test in abduction and external rotation position and positive Jobe sign in lateral position. (2) Imaging: magnetic resonance imaging, magnetic resonance arthrography or ultrasound showed rotator cuff injuries, including supraspinatus, infraspinatus, teres minor and subscapularis tendon injuries);
- Definite imaging diagnosis: magnetic resonance imaging, magnetic resonance arthrography or ultrasound examination;
- The shoulder joint did not receive surgical treatment;
- Both sexes, aged 20-80 years old;
- Stable vital signs, good communication, and active cooperation to complete the relevant evaluation and treatment;
Key exclusion criteria (8 listed)
- MRI showed medium, large and huge full-thickness rotator cuff tears;
- Skin damage or skin disease at the application site;
- Previous history of shoulder surgery;
- Pregnant or lactating women;
- Allergic constitution;
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 therapyThe experimental group received extracorporeal shock wave therapy combined with conventional rehabilitation therapy. The control group was only given conventional rehabilitation therapy. According to the patient's tolerance and the specific condition, extracorporeal shock wave therapy was performed twice a week, 2000-3000 times each time, energy parameters of 2.5-3.5Bar, 8-15Hz, treatment interval > 1 day, consecutive 4 weeks. Conventional rehabilitation therapy included medium frequency electricity, ultrasound, ultrashort wave, laser and wax therapy. Routine rehabilitation was given once a day, 5 times a week for 4 weeks. | Device | extracorporeal shock wave therapy group |
| conventional rehabilitation therapyConventional rehabilitation therapy included medium frequency electricity, ultrasound, ultrashort wave, laser, and wax therapy (same as the control group). Routine rehabilitation was given once a day, 5 times a week for 4 weeks. | Other | control group |
Primary outcome
Change from Baseline Visual Analogue Scale at 4 weeks
Time frame: baseline and 4 weeks
Visual analogue Scale is the most commonly used single-dimensional measurement of pain intensity. The scale mainly consists of a 10-cm straight line, one end of which indicates "no pain at all" and the other end indicates "the most severe pain imaginable" or "pain to the extreme" etc. The patient will be asked to mark the corresponding position on this line to represent the intensity of the pain they feel at that time.
Change from Baseline Range of Motion at 4 weeks
Time frame: baseline and 4 weeks
The range of motion of the shoulder joint refers to the active and passive range of motion of the shoulder joint measured with a protractor, including forward flexion, back extension, abduction, internal rotation, and external rotation.
Change from Baseline Constant-Murley Score at 4 weeks
Time frame: baseline and 4 weeks
Constant-Murley Score is the unified shoulder score of the European Society for Shoulder and Elbow Surgery. The left and right shoulder joints were scored separately. It mainly includes 8 aspects of shoulder joint-related problems: 1, pain; 2. Degree of influence on daily life; 3. The hand can lift the height that can be reached; 4. Upper limb abduction muscle strength; 5. The degree of upper limb forward lifting; 6, the degree of upper limb abduction; 7. The degree of external rotation of the upper limbs; 8, the degree of internal rotation of the upper limb can be achieved.
Change from Baseline Isokinetic muscle strength testing at 4 weeks
Time frame: baseline and 4 weeks
Isokinetic muscle testing can be used for quantitative measurement of muscle strength, and the evaluation results have objectivity, accuracy, repeatability, and high sensitivity.
Change from Baseline Magnetic resonance imaging at 4 weeks
Time frame: baseline and 4 weeks
Magnetic resonance imaging has good soft tissue resolution and can clearly show the injuries of tendons and ligaments around the shoulder joint. It is one of the main examination methods for the evaluation of rotator cuff injuries.
Change from Baseline Musculoskeletal ultrasound at 4 weeks
Time frame: baseline and 4 weeks
Musculoskeletal ultrasound uses high-frequency ultrasound to diagnose musculoskeletal diseases, which can clearly show the superficial soft tissue structures such as muscles, tendons, ligaments, peripheral nerves, and their lesions. It is one of the main examination methods for the evaluation of rotator cuff injuries.
5 secondary outcomes
Change from Baseline American Shoulder and Elbow Surgeons Score at 4 weeks
Time frame: baseline and 4 weeks
Change from Baseline Shoulder Pain and Disability Index at 4 weeks
Time frame: baseline and 4 weeks
Change from Baseline Disability of the Arm, Shoulder and Hand Score at 4 weeks
Time frame: baseline and 4 weeks
Change from Baseline University of California at Los Angeles Shoulder Scale at 4 weeks
Time frame: baseline and 4 weeks
Change from Baseline Pittsburgh sleep quality index at 4 weeks
Time frame: baseline and 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
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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.
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 conventional rehabilitation therapy in people with Rotator Cuff Injuries, run by Yong Liu, MD at 1 site 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Mar 2024. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yong liu (18098876656, fuwa52008@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Visual Analogue Scale at 4 weeks (time frame: baseline and 4 weeks). 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 25 Mar 2024.