Rotator Cuff LesionsNCT05032924
The Clinical and Biological Effect of ESWT With Combined PRP Therapy on Rotator Cuff Lesions
A study testing PPR group with ESWT, PPR group without ESWT and HA group with ESWT in people with Rotator Cuff Lesions, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Through the investigators previous study of the effect of transient increased cellular permeability after ESWT, combined ESWT and PRP may have better effect on the treatment of rotator cuff lesions. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Rotator Cuff Lesions
- What is being tested?
- PPR group with ESWT, PPR group without ESWT and HA group with ESWT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Aug 2021to 31 Jul 2024
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pain around the shoulder, a positive impingement sign, imaging diagnosis of rotator cuff pathology without complete tear
- do not respond to conservative therapy or rehabilitation for at least 3 months
- age between 35 and 80 years, who sign the informed consent form.
Who cannot join
- rheumatic diseases, SLE, diabetic neuropathy, glenohumeral osteoarthritis, full-thickness cuff tears, fractures, infections, or tumors
- received a subacromial injection within 3 weeks
- pregnant or want to become pregnant.
- arrhythmia, pacemaker, coagulopathy, or malignancy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Medical Hosptial
Kaohsiung City, 833
Ko Jih-Yang, +886975056255, kojy@cgmh.org.tw
About this study
Official title: The Clinical and Biological Effect of Extracorporeal Shock Wave Technology (ESWT) With Combined PRP Therapy on Rotator Cuff Lesions
Through the investigators previous study of the effect of transient increased cellular permeability after ESWT, combined ESWT and PRP may have better effect on the treatment of rotator cuff lesions. The investigators intend to conduct a prospective double blind randomized control study on the treatment effect of combined ESWT and PRP therapy for rotator cuff lesions without complete tearing. Constant Score, VAS and data from peripheral blood will be measured for the effectiveness evaluation. Shoulder MRI will be followed-up one year after ESWT. The investigators hypothesize that combined ESWT and PRP will be more effective for rotator cuff lesions.
Read the detailed description
Overall Design [Prospective randomized double-blind study for the clinical effect of combined ESWT and platelet-rich plasma (PRP) or PRP or ESWT alone or sham treatment on patients with shoulder rotator cuff lesions and without complete tear.]
The participants will be separated into 4 groups according to computer statistical randomization.
The investigators shall use STORZ MEDICAL Extracorporeal Shock Wave Therapy 3000 impulse 24KV (0.32mJ/mm2) Focus at two points (3000 impulse each point) near the insertion of supraspinatus and rotation interval of the involved shoulder.
PRP： The PRP form Regen Kit BCT 1 Platelet Rich Plasma PRP will be used and will be injected into the Subacromial bursa (Hyajoint injection as a control)
HYAJOINT Synovial Fluid Supplement, active ingredient: Sodium Hyaluronate 25 mg, package: 2.5 mL per syringe
The randomized, double-blind, placebo-controlled clinical study will involve 30-50 patients who have rotator cuff lesions without complete tear. The inclusion criteria are (1) patients who have pain around the shoulder, a positive impingement sign, and a positive imaging diagnosis of rotator cuff pathology without complete tear; (2) patients who do not respond to conservative therapy or rehabilitation for at least 3 months; and (3) patients age between 35 and 80 years, who sign the informed consent form. The investigators will exclude patients who have rheumatic diseases, glenohumeral osteoarthritis, full-thickness cuff tears, fractures, infections, or tumors; those who have received a subacromial injection within 3 weeks; and those who are pregnant or want to become pregnant; and those who have arrhythmia, pacemaker, coagulopathy, or malignancy.
The intent-to-treat population is a fully randomized group of patients who have a baseline value (Constant score and VAS before treatment). The imaging diagnosis of a rotator cuff lesion is made by a musculoskeletal radiologist who has considerable experience in interpreting magnetic resonance imaging (MRI) results for shoulders. On MRI, rotator cuff tendinosis is characterized by increased in tratendinous signal intensity onT2-weighted images without tendon disruption. The tendinosis of the MRI imaging was further diverted into three grades. Grade 1 indicates less than 1/3 of the supraspinatus tendon is involved, Grade 2 indicates 1/3 to 2/3 and Grade 3 indicates more than 2/3 of the supraspinatus tendon is involved. Partial-thickness tearing is characterized by the presence of focal hyperintense fluid or a fluid-like signal intensity that extended into the tendon on the T2-weighted images. A full thickness tear is diagnosed by the extension of hyperintense fluid or fluid-like signal intensity through the entire thickness of the interrupted rotator cuff tendon on T2-weighted images.
Every participant will have Subacromial injection of 2.5 ml PRP or HA (control) one week before ESWT or sham therapy. In Group I, patients receive 3000 impulses of shockwaves at 24kV (energy flux density, 0.32mJ/mm2) to the affected shoulder as a 1-time treatment. Treatments are performed on an outpatient basis. The area of treatment (2 points near the supraspinatus insertion and rotator interval) is focused with a control guide on the machine, and surgical lubricant is placed on the skin in contact with the shockwave tube with the patient in a supine position. The sham treatment entail use of the device in which the silicone pad was removed from the stand-off device, but the participants can still hear the sound of the shock wave and have tingling sensation over the skin but without energy transduced. The participants' vital signs and local discomfort are monitored throughout the course of treatment. The treated area is inspected for local swelling, ecchymosis, or hematoma immediately after the treatment.
The participants will have a pain medication-free interval 3 days prior to each evaluation. After treatment and during follow-up, participants will be restricted to the use of a 750mg of acetaminophen per day for pain, in order to facilitate usage and comparison of the medications among the patients. Follow-up examinations are performed independently by one of the coauthors, who is blinded to patient treatment status at 1week, 2week, 1month, 3 months, 6 months, and 12 months after treatment. Peripheral blood (10cc) will be collected one week and 1 month after treatment and shoulder MRI will be checked 12 months after treatment. The participants who have persistent shoulder discomfort may be advised to undergo surgical intervention.
- Conditions
- Rotator Cuff Lesions
- Being tested
- PPR group with ESWT, PPR group without ESWT, HA group with ESWT, HA group without ESWT
- Keywords
- Platelet Rich Plasma (PRP), Extracorporeal shock wave therapy (ESWT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPR group with ESWTCombination product
extracorporeal shock wave (ESWT) (STORZ MEDICAL Extracorporeal Shock Wave Therapy) (3000 impulse, each point, 24 KV, 0.32 mJ/mm2) one week after PRP or HA injection
PPR group without ESWTCombination product
PRP or HA injection only
HA group with ESWTCombination product
extracorporeal shock wave (ESWT) (STORZ MEDICAL Extracorporeal Shock Wave Therapy)
HA group without ESWTCombination product
PRP or HA injection only
| Study group | Role | What they receive |
|---|---|---|
| PPR group | Experimental | Receive PRP injection only (PRP form Regen Kit BCT 1) Receives: Combination Product: PPR group with ESWT; Combination Product: PPR group without ESWT |
| HA group | Placebo comparator | Receive HA injection only (HYAJOINT Synovial Fluid Supplement, active ingredient: Sodium Hyaluronate 25 mg, package: 2.5 mL per syringe) Receives: Combination Product: HA group with ESWT; Combination Product: HA group without ESWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant Score
The Constant Score contains pain (15 points), activities of daily living (20 points), mobility (40 points), and strength (25 points). Improve the Constant Score by 10 points for treatment success. For monitoring the participants' recovery progress, will measure and record at 1 month after treatment.
Measured: measure and record at 1 month after treatment.
Constant Score
The Constant Score contains pain (15 points), activities of daily living (20 points), mobility (40 points), and strength (25 points). Improve the Constant Score by 10 points for treatment success. For monitoring the participants' recovery progress, will measure and record at 3 months after treatment.
Measured: measure and record at 3 months after treatment.
Constant Score
The Constant Score contains pain (15 points), activities of daily living (20 points), mobility (40 points), and strength (25 points). Improve the Constant Score by 10 points for treatment success. For monitoring the participants' recovery progress, will measure and record at 6 months after treatment.
Measured: measure and record at 6 months after treatment.
Constant Score
The Constant Score contains pain (15 points), activities of daily living (20 points), mobility (40 points), and strength (25 points). Improve the Constant Score by 10 points for treatment success. For monitoring the participants' recovery progress, will measure and record at 12 months after treatment.
Measured: measure and record at 12 months after treatment.
visual analog scale (VAS)
Assess whether the pain level is reduced. The VAS with two endpoints representing 0 ('no pain') and 10 ('extreme pain'). For monitoring the patients' recovery progress, will measure and record at 1 month after treatment.
Measured: measure and record at 1 month after treatment.
visual analog scale (VAS)
Assess whether the pain level is reduced. The VAS with two endpoints representing 0 ('no pain') and 10 ('extreme pain'). For monitoring the patients' recovery progress, will measure and record at 3 months after treatment.
Measured: measure and record at 3 months after treatment.
visual analog scale (VAS)
Assess whether the pain level is reduced. The VAS with two endpoints representing 0 ('no pain') and 10 ('extreme pain'). For monitoring the patients' recovery progress, will measure and record at 6 months after treatment.
Measured: measure and record at 6 months after treatment.
visual analog scale (VAS)
Assess whether the pain level is reduced. The VAS with two endpoints representing 0 ('no pain') and 10 ('extreme pain'). For monitoring the patients' recovery progress, will measure and record at 12 months after treatment.
Measured: measure and record at 12 months after treatment.
Range of Motion (ROM)
Assess whether the range of motion is increased. Measure the motions: abduction, elevation through flexion, external rotation and internal rotation. For monitoring the patients' recovery progress, will measure and record at 1 month after treatment.
Measured: measure and record at 1 month after treatment.
Range of Motion (ROM)
Assess whether the range of motion is increased. Measure the motions: abduction, elevation through flexion, external rotation and internal rotation. For monitoring the patients' recovery progress, will measure and record at 3 months after treatment.
Measured: measure and record at 3 months after treatment.
Range of Motion (ROM)
Assess whether the range of motion is increased. Measure the motions: abduction, elevation through flexion, external rotation and internal rotation. For monitoring the patients' recovery progress, will measure and record at 6 months after treatment.
Measured: measure and record at 6 months after treatment.
Range of Motion (ROM)
Assess whether the range of motion is increased. Measure the motions: abduction, elevation through flexion, external rotation and internal rotation. For monitoring the patients' recovery progress, will measure and record at 12 months after treatment.
Measured: measure and record at 12 months after treatment.
MRI
Take shoulder MRI to compare the difference before and after treatment. The degeneration of the supraspic is graded as: grade 1 ≤ 1/3; 1/3 < grade 2 < 2/3; grade 3 ≥ 2/3.
Measured: shoulder MRI will be checked 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start2 Aug 2021
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff LesionsStudies 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
- Participants are randomly into four group to receive either shockwave or PRP or sham (HA) treatment based on a computerized statistical randomization. Every participant will have Subacromial injection of 2.5 ml PRP form Regen Kit BCT 1 or HA (control)(HYAJOINT Synovial Fluid Supplement, active ingredient: Sodium Hyaluronate 25 mg, package: 2.5 mL per syringe) one week before ESWT or sham therapy. Follow-up examinations are performed independently by one of the coauthors, who is blinded to patient treatment status at 1week, 2week, 1month, 3 months, 6 months, and 12 months after treatment. Peripheral blood (10cc) will be collected one week and 1 month after treatment and shoulder MRI will be checked 12 months after treatment. Participants who have persistent shoulder discomfort may be advised to undergo surgical intervention.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jih-Yang Ko, Chang Gung Memorial Hospital
- Investigators
- Jih-Yang Ko, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032924
- Sponsor's protocol ID
- 202100718A3A3
- Status last verified
- Aug 2021
- First submitted
- 3 Aug 2021
- Last updated
- 2 Sep 2021
- 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 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical and Biological Effect of Extracorporeal Shock Wave Technology (ESWT) With Combined PRP Therapy on Rotator Cuff Lesions
- ClinicalTrials.gov ID
- NCT05032924
- Acronym / sponsor ID
- 202100718A3A3
- Conditions
- Rotator Cuff Lesions
- Keywords
- Platelet Rich Plasma (PRP), Extracorporeal shock wave therapy (ESWT)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 2 Sep 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.
Through the investigators previous study of the effect of transient increased cellular permeability after ESWT, combined ESWT and PRP may have better effect on the treatment of rotator cuff lesions. The investigators intend to conduct a prospective double blind randomized control study on the treatment effect of combined ESWT and PRP therapy for rotator cuff lesions without complete tearing. Constant Score, VAS and data from peripheral blood will be measured for the effectiveness evaluation. Shoulder MRI will be followed-up one year after ESWT. The investigators hypothesize that combined ESWT and PRP will be more effective for rotator cuff lesions.
Detailed description
Overall Design [Prospective randomized double-blind study for the clinical effect of combined ESWT and platelet-rich plasma (PRP) or PRP or ESWT alone or sham treatment on patients with shoulder rotator cuff lesions and without complete tear.]
The participants will be separated into 4 groups according to computer statistical randomization.
The investigators shall use STORZ MEDICAL Extracorporeal Shock Wave Therapy 3000 impulse 24KV (0.32mJ/mm2) Focus at two points (3000 impulse each point) near the insertion of supraspinatus and rotation interval of the involved shoulder.
PRP： The PRP form Regen Kit BCT 1 Platelet Rich Plasma PRP will be used and will be injected into the Subacromial bursa (Hyajoint injection as a control)
HYAJOINT Synovial Fluid Supplement, active ingredient: Sodium Hyaluronate 25 mg, package: 2.5 mL per syringe
The randomized, double-blind, placebo-controlled clinical study will involve 30-50 patients who have rotator cuff lesions without complete tear. The inclusion criteria are (1) patients who have pain around the shoulder, a positive impingement sign, and a positive imaging diagnosis of rotator cuff pathology without complete tear; (2) patients who do not respond to conservative therapy or rehabilitation for at least 3 months; and (3) patients age between 35 and 80 years, who sign the informed consent form. The investigators will exclude patients who have rheumatic diseases, glenohumeral osteoarthritis, full-thickness cuff tears, fractures, infections, or tumors; those who have received a subacromial injection within 3 weeks; and those who are pregnant or want to become pregnant; and those who have arrhythmia, pacemaker, coagulopathy, or malignancy.
The intent-to-treat population is a fully randomized group of patients who have a baseline value (Constant score and VAS before treatment). The imaging diagnosis of a rotator cuff lesion is made by a musculoskeletal radiologist who has considerable experience in interpreting magnetic resonance imaging (MRI) results for shoulders. On MRI, rotator cuff tendinosis is characterized by increased in tratendinous signal intensity onT2-weighted images without tendon disruption. The tendinosis of the MRI imaging was further diverted into three grades. Grade 1 indicates less than 1/3 of the supraspinatus tendon is involved, Grade 2 indicates 1/3 to 2/3 and Grade 3 indicates more than 2/3 of the supraspinatus tendon is involved. Partial-thickness tearing is characterized by the presence of focal hyperintense fluid or a fluid-like signal intensity that extended into the tendon on the T2-weighted images. A full thickness tear is diagnosed by the extension of hyperintense fluid or fluid-like signal intensity through the entire thickness of the interrupted rotator cuff tendon on T2-weighted images.
Every participant will have Subacromial injection of 2.5 ml PRP or HA (control) one week before ESWT or sham therapy. In Group I, patients receive 3000 impulses of shockwaves at 24kV (energy flux density, 0.32mJ/mm2) to the affected shoulder as a 1-time treatment. Treatments are performed on an outpatient basis. The area of treatment (2 points near the supraspinatus insertion and rotator interval) is focused with a control guide on the machine, and surgical lubricant is placed on the skin in contact with the shockwave tube with the patient in a supine position. The sham treatment entail use of the device in which the silicone pad was removed from the stand-off device, but the participants can still hear the sound of the shock wave and have tingling sensation over the skin but without energy transduced. The participants' vital signs and local discomfort are monitored throughout the course of treatment. The treated area is inspected for local swelling, ecchymosis, or hematoma immediately after the treatment.
The participants will have a pain medication-free interval 3 days prior to each evaluation. After treatment and during follow-up, participants will be restricted to the use of a 750mg of acetaminophen per day for pain, in order to facilitate usage and comparison of the medications among the patients. Follow-up examinations are performed independently by one of the coauthors, who is blinded to patient treatment status at 1week, 2week, 1month, 3 months, 6 months, and 12 months after treatment. Peripheral blood (10cc) will be collected one week and 1 month after treatment and shoulder MRI will be checked 12 months after treatment. The participants who have persistent shoulder discomfort may be advised to undergo surgical intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Participants are randomly into four group to receive either shockwave or PRP or sham (HA) treatment based on a computerized statistical randomization. Every participant will have Subacromial injection of 2.5 ml PRP form Regen Kit BCT 1 or HA (control)(HYAJOINT Synovial Fluid Supplement, active ingredient: Sodium Hyaluronate 25 mg, package: 2.5 mL per syringe) one week before ESWT or sham therapy. Follow-up examinations are performed independently by one of the coauthors, who is blinded to patient treatment status at 1week, 2week, 1month, 3 months, 6 months, and 12 months after treatment. Peripheral blood (10cc) will be collected one week and 1 month after treatment and shoulder MRI will be checked 12 months after treatment. Participants who have persistent shoulder discomfort may be advised to undergo surgical intervention.
| Arm | Type | Receives |
|---|---|---|
| PPR group | Experimental | Combination Product: PPR group with ESWT, Combination Product: PPR group without ESWTReceive PRP injection only (PRP form Regen Kit BCT 1) |
| HA group | Placebo comparator | Combination Product: HA group with ESWT, Combination Product: HA group without ESWTReceive HA injection only (HYAJOINT Synovial Fluid Supplement, active ingredient: Sodium Hyaluronate 25 mg, package: 2.5 mL per syringe) |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- pain around the shoulder, a positive impingement sign, imaging diagnosis of rotator cuff pathology without complete tear
- do not respond to conservative therapy or rehabilitation for at least 3 months
- age between 35 and 80 years, who sign the informed consent form.
Key exclusion criteria (4 listed)
- rheumatic diseases, SLE, diabetic neuropathy, glenohumeral osteoarthritis, full-thickness cuff tears, fractures, infections, or tumors
- received a subacromial injection within 3 weeks
- pregnant or want to become pregnant.
- arrhythmia, pacemaker, coagulopathy, or malignancy
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 |
|---|---|---|
| PPR group with ESWTextracorporeal shock wave (ESWT) (STORZ MEDICAL Extracorporeal Shock Wave Therapy) (3000 impulse, each point, 24 KV, 0.32 mJ/mm2) one week after PRP or HA injection | Combination product | PPR group |
| PPR group without ESWTPRP or HA injection only | Combination product | PPR group |
| HA group with ESWTextracorporeal shock wave (ESWT) (STORZ MEDICAL Extracorporeal Shock Wave Therapy) | Combination product | HA group |
| HA group without ESWTPRP or HA injection only | Combination product | HA group |
Primary outcome
Constant Score
Time frame: measure and record at 1 month after treatment.
The Constant Score contains pain (15 points), activities of daily living (20 points), mobility (40 points), and strength (25 points). Improve the Constant Score by 10 points for treatment success. For monitoring the participants' recovery progress, will measure and record at 1 month after treatment.
Constant Score
Time frame: measure and record at 3 months after treatment.
The Constant Score contains pain (15 points), activities of daily living (20 points), mobility (40 points), and strength (25 points). Improve the Constant Score by 10 points for treatment success. For monitoring the participants' recovery progress, will measure and record at 3 months after treatment.
Constant Score
Time frame: measure and record at 6 months after treatment.
The Constant Score contains pain (15 points), activities of daily living (20 points), mobility (40 points), and strength (25 points). Improve the Constant Score by 10 points for treatment success. For monitoring the participants' recovery progress, will measure and record at 6 months after treatment.
Constant Score
Time frame: measure and record at 12 months after treatment.
The Constant Score contains pain (15 points), activities of daily living (20 points), mobility (40 points), and strength (25 points). Improve the Constant Score by 10 points for treatment success. For monitoring the participants' recovery progress, will measure and record at 12 months after treatment.
visual analog scale (VAS)
Time frame: measure and record at 1 month after treatment.
Assess whether the pain level is reduced. The VAS with two endpoints representing 0 ('no pain') and 10 ('extreme pain'). For monitoring the patients' recovery progress, will measure and record at 1 month after treatment.
visual analog scale (VAS)
Time frame: measure and record at 3 months after treatment.
Assess whether the pain level is reduced. The VAS with two endpoints representing 0 ('no pain') and 10 ('extreme pain'). For monitoring the patients' recovery progress, will measure and record at 3 months after treatment.
visual analog scale (VAS)
Time frame: measure and record at 6 months after treatment.
Assess whether the pain level is reduced. The VAS with two endpoints representing 0 ('no pain') and 10 ('extreme pain'). For monitoring the patients' recovery progress, will measure and record at 6 months after treatment.
visual analog scale (VAS)
Time frame: measure and record at 12 months after treatment.
Assess whether the pain level is reduced. The VAS with two endpoints representing 0 ('no pain') and 10 ('extreme pain'). For monitoring the patients' recovery progress, will measure and record at 12 months after treatment.
Range of Motion (ROM)
Time frame: measure and record at 1 month after treatment.
Assess whether the range of motion is increased. Measure the motions: abduction, elevation through flexion, external rotation and internal rotation. For monitoring the patients' recovery progress, will measure and record at 1 month after treatment.
Range of Motion (ROM)
Time frame: measure and record at 3 months after treatment.
Assess whether the range of motion is increased. Measure the motions: abduction, elevation through flexion, external rotation and internal rotation. For monitoring the patients' recovery progress, will measure and record at 3 months after treatment.
Range of Motion (ROM)
Time frame: measure and record at 6 months after treatment.
Assess whether the range of motion is increased. Measure the motions: abduction, elevation through flexion, external rotation and internal rotation. For monitoring the patients' recovery progress, will measure and record at 6 months after treatment.
Range of Motion (ROM)
Time frame: measure and record at 12 months after treatment.
Assess whether the range of motion is increased. Measure the motions: abduction, elevation through flexion, external rotation and internal rotation. For monitoring the patients' recovery progress, will measure and record at 12 months after treatment.
MRI
Time frame: shoulder MRI will be checked 12 months after treatment
Take shoulder MRI to compare the difference before and after treatment. The degeneration of the supraspic is graded as: grade 1 ≤ 1/3; 1/3 < grade 2 < 2/3; grade 3 ≥ 2/3.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
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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.
Jih-Yang Ko, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPR group with ESWT, PPR group without ESWT and HA group with ESWT in people with Rotator Cuff Lesions, 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 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: status not confirmed, as of the sponsor's last update on 2 Sep 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jih-Yang Ko, MD (886-7-731-7123 ext. 8003, kojy@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant Score (time frame: measure and record at 1 month after treatment.). The study lists 13 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 2 Sep 2021.