Rotator Cuff LesionsNCT05034757
The Development of a Guidance of Combined HA and ESWT for Non-calcific Rotator Cuff Lesions Without Complete Tear
A study testing HA only, ESWT once and ESWT twice in people with Rotator Cuff Lesions, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The rotator cuff lesions are common disorders of the shoulder joint and mainly caused by intrinsic degeneration and outlet impingement. The symptoms include pain, discomfort, weakness, range of motion limitation, and impingement. 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?
- HA only, ESWT once and ESWT twice
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Oct 2019to 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 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
- Diagnosis of non-calcific rotator cuff pathology without complete tear
- Do not respond to conservative therapy or rehabilitation for at least 3 months
Who cannot join
- Rheumatic diseases
- Glenohumeral osteoarthritis
- Full-thickness cuff tears
- Fractures
- Infections
- Tumors
- Received a subacromial injection within 3 weeks
- Pregnant or want to become pregnant.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Kaohsiung City, 833
Jih-Yang Ko, MD, 886-7-731-7123 ext. 8003, kojy@cgmh.org.tw
Jih-Yang Ko, MD
About this study
Official title: The Development of a Guidance of Combined Hyaluronate and Extracorporeal Shockwave Therapy (ESWT) for Non-calcific Rotator Cuff Lesions Without Complete Tear
The rotator cuff lesions are common disorders of the shoulder joint and mainly caused by intrinsic degeneration and outlet impingement. The symptoms include pain, discomfort, weakness, range of motion limitation, and impingement. The initial treatment of rotator cuff lesions are non-surgical especially for non-full thickness tearing and include rehabilitation and medications given orally, topically, or parenterally. Although many patients with rotator cuff lesions or subacromial pain are treated with, and will respond to non- surgical treatment alone, surgical intervention with subacromial decompression and rotator cuff repair is often used as an early treatment choice or in recalcitrant cases. The indications for surgery are persistent and severe shoulder pain combined with functional restrictions that are resistant to conservative measures. However, the effectiveness of this procedure is still elusive. Some studies have compared decompression plus subacromial bursectomy with bursectomy alone and reported no significant difference in clinical outcome between groups.
In addition, arthroscopic subacromial decompression for shouled impingement was currently challenged because some high-quality prospective studies including that from Oxford university showed similar outcomes between surgical and non-surgical treatment. Therefore more efficient non-surgical treatments were needed for the rotator cuff lesions without complete tear.
Read more
The investigators have successfully treated non- calcific rotator cuff lesions without complete tearing with hyaluronate and published our data in J Shoulder Elbow surgery. Jun 19:557-63, 2010.
In the Phase III study, the investigators will perform three subacromial hyaluronate injections and zero to two sessions of extracorporeal shock wave therapy (ESWT) for these patients. The investigators hypothesize that through the actions of anti-inflammation, neovascularization and temporary cell permeability increment, a combined therapy of HA and ESWT may offer better therapeutic effects on the non-calcific rotator cuff lesion without complete tearing. The investigators will evaluate the treatment effects with Constant score and VAS scale and also check the changes or expressions of cytokines, growth factors, functional proteins, from the peripheral blood.
Read the detailed description
The rotator cuff lesions are common disorders of the shoulder joint and mainly caused by intrinsic degeneration and outlet impingement. The symptoms include pain, discomfort, weakness, range of motion limitation, and impingement. The initial treatment of rotator cuff lesions are non-surgical especially for non-full thickness tearing and include rehabilitation and medications given orally, topically, or parenterally.
Although many patients with rotator cuff lesions or subacromial pain are treated with, and will respond to non- surgical treatment alone, surgical intervention with subacromial decompression and rotator cuff repair is often used as an early treatment choice or in recalcitrant cases. The indications for surgery are persistent and severe subacromial shoulder pain combined with functional restrictions that are resistant to conservative measures. However, the effectiveness and necessity of this procedure is still elusive. Some studies have compare decompression plus subacromial bursectomy with bursectomy alone and reported no significant difference in clinical outcome between groups.
In addition, arthroscopic subacromial decompression for shouled impingement was currently challenged because some high-quality prospective studies including that from Oxford university showed similar outcomes between surgical and non-surgical treatment. Therefore more efficient non-surgical treatments were needed for the rotator cuff lesions without complete tear.
The investigators have successfully treated non-calcific rotator cuff lesions without complete with hyaluronate and published our data in J Shoulder Elbow Surg. Jun 19:557-63,2010.
In the phase III study, the investigators will perform three subacromial hyaluronate injections and zero to two sessions of extracorporeal therapy (ESWT). The investigators hypothesize that through the actions of anti-inflammation, neovascularization and temporary cell permeability increment of ESWT, a combined therapy of HA and ESWT may offer better therapeutic effects on the non-calcific rotator cuff lesion without complete tearing. The investigators will evaluate the treatment effects with constant score and VAS, and also check the changesor expressions of cytokines, growth factors, functional protein, from the peripheral blood.
- Acceptance criteria: The randomized, double-blind, placebo-controlled clinical study will involve 69 or more patients who have non-calcific 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 non-calcific 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. The sample size is calculated under the expectation of an improvement in the Constant score of 10 points, with an SD of 12 points in each group, and a power value of 0.8. For this study design, the minimal number of patients required in each group is 23, by use of an independent-samples t test. 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 both magnetic resonance imaging (MRI) and sonographic results for shoulders. On the sonogram, hypoechoic thickening of the rotator cuff indicates tendinosis. Focal thinning or focal hypoechoic areas of discontinuity in the rotator cuff are suggestive of partial-thickness tearing. In cases of the hypoechoic gap extending through the entire rotator cuff, tendon retraction, or the absence of a visible rotator cuff, a full thickness tear is assumed to be present. On MRI, rotator cuff tendinosis is characterized by increased intratendinous signal intensity on T2-weighted images without tendon disruption. 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.
- Experiment design and method Patients are then randomly into three groups and every patient receives three injections of HA along with ESWT treatment based on statistical randomization. For ESWT of the shoulder the patient will receive Storz Extracorporeal Shock Wave Therapy 3000 impulses (each point) of shockwaves at 24kV (energy flux density, 0.32mJ/mm2) to the affected shoulder. Treatments are performed on an outpatient basis. The areas of treatment (2 points) near the supraspinatus insertion is focused with a control guide on the machine, and surgical lubricant is placed on the skin in contact with the shockwave tube. The sham treatment entails use of the same device in which the shockwave generator is disconnected. The patients' 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. Our primary endpoint is the Constant Score improvement by 10 points and the treatment success is followed up to 1 year. The Constant score pain score and the range of shoulder motion are measured. Another kind of pain and pain that requires surgery is classified as a failure case, which is the secondary endpoint.
- Rehabilitation including gentle flexion, abduction, internal rotation and external rotation exercises, pendulum exercises, and resistant exercises will be instructed and continued during the study period.
Patients will have a pain medication-free interval 2 days prior to each evaluation. After treatment and during follow-up, patients will be restricted to the use of a 750mg of acetaminophen per day for pain, in order to fascilitate usage and comparison of the medications among the patients. Follow-up examinations with range of motion, VAS and Constant score are performed independently by one of the coauthors, who is blinded to patient treatment status during the treatment course and at 1week, 1month, 3months, 6 months, and 12 months after treatment. Peripheral blood (10cc) will be collected during the treatment course and 1 week, 1 month and 3 month after treatment and shoulder MRI will be checked 12 months after treatment. Patients who have persistent shoulder discomfort may be advised to undergo surgical intervention.
- Conditions
- Rotator Cuff Lesions
- Being tested
- HA only, ESWT once, ESWT twice
- Keywords
- HA, ESWT, non-calcific rotator cuff lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HA onlyOther
HA injection only
ESWT onceOther
ESWT of the shoulder the patient will receives STORZ Extracorporeal Shock Wave Therapy 3000 impulses (each point) of shockwaves at 24kV (energy flux density, 0.32mJ/mm2) to the affected shoulder
ESWT twiceOther
ESWT of the shoulder the patient will receives STORZ Extracorporeal Shock Wave Therapy 3000 impulses (each point) of shockwaves at 24kV (energy flux density, 0.32mJ/mm2) to the affected shoulder
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronate | Experimental | HA injection Receives: Other: HA only |
| HA + ESWT | Experimental | HA + ESWT Receives: Other: ESWT once; Other: ESWT twice |
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 during the treatment course.
Measured: measure and record during the treatment course.
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 during the treatment course.
Measured: measure and record during the treatment course.
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 during the treatment course.
Measured: measure and record during the treatment course.
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 posted5 Sep 2021
- Study start31 Oct 2019
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
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 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 138 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
- NCT05034757
- Sponsor's protocol ID
- 201900290B0A3
- Status last verified
- Aug 2021
- First submitted
- 3 Aug 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ko JY, Huang CC, Huang PH, Chen JW, Liao CY, Kuo SJ. Effects of supplementing extracorporeal shockwave therapy to hyaluronic acid injection among patients with rotator cuff lesions without complete tear: a prospective double-blinded randomized study. Int J Surg. 2024 Dec 1;110(12):7421-7433. doi: 10.1097/JS9.0000000000002063.
PubMed 39172722
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of a Guidance of Combined Hyaluronate and Extracorporeal Shockwave Therapy (ESWT) for Non-calcific Rotator Cuff Lesions Without Complete Tear
- ClinicalTrials.gov ID
- NCT05034757
- Acronym / sponsor ID
- 201900290B0A3
- Conditions
- Rotator Cuff Lesions
- Keywords
- HA, ESWT, non-calcific rotator cuff lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 5 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.
The rotator cuff lesions are common disorders of the shoulder joint and mainly caused by intrinsic degeneration and outlet impingement. The symptoms include pain, discomfort, weakness, range of motion limitation, and impingement. The initial treatment of rotator cuff lesions are non-surgical especially for non-full thickness tearing and include rehabilitation and medications given orally, topically, or parenterally. Although many patients with rotator cuff lesions or subacromial pain are treated with, and will respond to non- surgical treatment alone, surgical intervention with subacromial decompression and rotator cuff repair is often used as an early treatment choice or in recalcitrant cases. The indications for surgery are persistent and severe shoulder pain combined with functional restrictions that are resistant to conservative measures. However, the effectiveness of this procedure is still elusive. Some studies have compared decompression plus subacromial bursectomy with bursectomy alone and reported no significant difference in clinical outcome between groups.
In addition, arthroscopic subacromial decompression for shouled impingement was currently challenged because some high-quality prospective studies including that from Oxford university showed similar outcomes between surgical and non-surgical treatment. Therefore more efficient non-surgical treatments were needed for the rotator cuff lesions without complete tear.
The investigators have successfully treated non- calcific rotator cuff lesions without complete tearing with hyaluronate and published our data in J Shoulder Elbow surgery. Jun 19:557-63, 2010.
In the Phase III study, the investigators will perform three subacromial hyaluronate injections and zero to two sessions of extracorporeal shock wave therapy (ESWT) for these patients. The investigators hypothesize that through the actions of anti-inflammation, neovascularization and temporary cell permeability increment, a combined therapy of HA and ESWT may offer better therapeutic effects on the non-calcific rotator cuff lesion without complete tearing. The investigators will evaluate the treatment effects with Constant score and VAS scale and also check the changes or expressions of cytokines, growth factors, functional proteins, from the peripheral blood.
Detailed description
The rotator cuff lesions are common disorders of the shoulder joint and mainly caused by intrinsic degeneration and outlet impingement. The symptoms include pain, discomfort, weakness, range of motion limitation, and impingement. The initial treatment of rotator cuff lesions are non-surgical especially for non-full thickness tearing and include rehabilitation and medications given orally, topically, or parenterally.
Although many patients with rotator cuff lesions or subacromial pain are treated with, and will respond to non- surgical treatment alone, surgical intervention with subacromial decompression and rotator cuff repair is often used as an early treatment choice or in recalcitrant cases. The indications for surgery are persistent and severe subacromial shoulder pain combined with functional restrictions that are resistant to conservative measures. However, the effectiveness and necessity of this procedure is still elusive. Some studies have compare decompression plus subacromial bursectomy with bursectomy alone and reported no significant difference in clinical outcome between groups.
In addition, arthroscopic subacromial decompression for shouled impingement was currently challenged because some high-quality prospective studies including that from Oxford university showed similar outcomes between surgical and non-surgical treatment. Therefore more efficient non-surgical treatments were needed for the rotator cuff lesions without complete tear.
The investigators have successfully treated non-calcific rotator cuff lesions without complete with hyaluronate and published our data in J Shoulder Elbow Surg. Jun 19:557-63,2010.
In the phase III study, the investigators will perform three subacromial hyaluronate injections and zero to two sessions of extracorporeal therapy (ESWT). The investigators hypothesize that through the actions of anti-inflammation, neovascularization and temporary cell permeability increment of ESWT, a combined therapy of HA and ESWT may offer better therapeutic effects on the non-calcific rotator cuff lesion without complete tearing. The investigators will evaluate the treatment effects with constant score and VAS, and also check the changesor expressions of cytokines, growth factors, functional protein, from the peripheral blood.
- Acceptance criteria: The randomized, double-blind, placebo-controlled clinical study will involve 69 or more patients who have non-calcific 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 non-calcific 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. The sample size is calculated under the expectation of an improvement in the Constant score of 10 points, with an SD of 12 points in each group, and a power value of 0.8. For this study design, the minimal number of patients required in each group is 23, by use of an independent-samples t test. 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 both magnetic resonance imaging (MRI) and sonographic results for shoulders. On the sonogram, hypoechoic thickening of the rotator cuff indicates tendinosis. Focal thinning or focal hypoechoic areas of discontinuity in the rotator cuff are suggestive of partial-thickness tearing. In cases of the hypoechoic gap extending through the entire rotator cuff, tendon retraction, or the absence of a visible rotator cuff, a full thickness tear is assumed to be present. On MRI, rotator cuff tendinosis is characterized by increased intratendinous signal intensity on T2-weighted images without tendon disruption. 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.
- Experiment design and method Patients are then randomly into three groups and every patient receives three injections of HA along with ESWT treatment based on statistical randomization. For ESWT of the shoulder the patient will receive Storz Extracorporeal Shock Wave Therapy 3000 impulses (each point) of shockwaves at 24kV (energy flux density, 0.32mJ/mm2) to the affected shoulder. Treatments are performed on an outpatient basis. The areas of treatment (2 points) near the supraspinatus insertion is focused with a control guide on the machine, and surgical lubricant is placed on the skin in contact with the shockwave tube. The sham treatment entails use of the same device in which the shockwave generator is disconnected. The patients' 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. Our primary endpoint is the Constant Score improvement by 10 points and the treatment success is followed up to 1 year. The Constant score pain score and the range of shoulder motion are measured. Another kind of pain and pain that requires surgery is classified as a failure case, which is the secondary endpoint.
- Rehabilitation including gentle flexion, abduction, internal rotation and external rotation exercises, pendulum exercises, and resistant exercises will be instructed and continued during the study period.
Patients will have a pain medication-free interval 2 days prior to each evaluation. After treatment and during follow-up, patients will be restricted to the use of a 750mg of acetaminophen per day for pain, in order to fascilitate usage and comparison of the medications among the patients. Follow-up examinations with range of motion, VAS and Constant score are performed independently by one of the coauthors, who is blinded to patient treatment status during the treatment course and at 1week, 1month, 3months, 6 months, and 12 months after treatment. Peripheral blood (10cc) will be collected during the treatment course and 1 week, 1 month and 3 month after treatment and shoulder MRI will be checked 12 months after treatment. Patients 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
| Arm | Type | Receives |
|---|---|---|
| Hyaluronate | Experimental | Other: HA onlyHA injection |
| HA + ESWT | Experimental | Other: ESWT once, Other: ESWT twiceHA + ESWT |
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
- Diagnosis of non-calcific rotator cuff pathology without complete tear
- Do not respond to conservative therapy or rehabilitation for at least 3 months
Key exclusion criteria (8 listed)
- Rheumatic diseases
- Glenohumeral osteoarthritis
- Full-thickness cuff tears
- Fractures
- Infections
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 |
|---|---|---|
| HA onlyHA injection only | Other | Hyaluronate |
| ESWT onceESWT of the shoulder the patient will receives STORZ Extracorporeal Shock Wave Therapy 3000 impulses (each point) of shockwaves at 24kV (energy flux density, 0.32mJ/mm2) to the affected shoulder | Other | HA + ESWT |
| ESWT twiceESWT of the shoulder the patient will receives STORZ Extracorporeal Shock Wave Therapy 3000 impulses (each point) of shockwaves at 24kV (energy flux density, 0.32mJ/mm2) to the affected shoulder | Other | HA + ESWT |
Primary outcome
Constant Score
Time frame: measure and record during the treatment course.
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 during the treatment course.
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 during the treatment course.
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 during the treatment course.
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 during the treatment course.
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 during the treatment course.
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 5 Sep 2021.
- Derived from this study: PubMed 39172722Ko JY, Huang CC, Huang PH, Chen JW, Liao CY, Kuo SJ. Effects of supplementing extracorporeal shockwave therapy to hyaluronic acid injection among patients with rotator cuff lesions without complete tear: a prospective double-blinded randomized study. Int J Surg. 2024 Dec 1;110(12):7421-7433. doi: 10.1097/JS9.0000000000002063.
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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 HA only, ESWT once and ESWT twice 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 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 5 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. 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, 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 during the treatment course.). The study lists 16 primary outcomes in all. 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 NCT05034757, 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 5 Sep 2021.