Chronic Rotator Cuff TendinopathyNCT06700746
Efficacy of Dextrose Prolotherapy Compare With ESWT in the Treatment of Chronic Rotator Cuff Tendinopathy
A study testing Prolotherapy and Extracorporeal shock wave therapy (ESWT) in people with Chronic Rotator Cuff Tendinopathy, run by Mahidol University at 1 site in Thailand.
Trial summary
To compare the efficacy of dextrose solution injection with ESWT for pain reduction in rotator cuff tendinopathy. Additionally, secondary objective is to evaluate DASH and active range of motion of shoulder joint Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rotator Cuff Tendinopathy
- What is being tested?
- Prolotherapy and Extracorporeal shock wave therapy (ESWT)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteThailand
- Study dates
- 10 Nov 2023to 20 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic shoulder pain for at least 3 months
- Unilateral affected side
- History of unsuccessful conservative treatment
- Age 18 years or older
Who cannot join
- Rotator cuff complete tear
- Local or generalized arthritis
- Previous shoulder surgery
- Previous history allergy to local anesthesia
- Pregnancy
- Current infectious or tumorous disease
- Dysfunction in the neck or thoracic region of both
- Coagulation disturbance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Dextrose Prolotherapy Compare With Extracorporeal Shock Wave Therapy in the Treatment of Chronic Rotator Cuff Tendinopathy
To compare the efficacy of dextrose solution injection with ESWT for pain reduction in rotator cuff tendinopathy.
Additionally, secondary objective is to evaluate DASH and active range of motion of shoulder joint
- Conditions
- Chronic Rotator Cuff Tendinopathy
- Being tested
- Prolotherapy, Extracorporeal shock wave therapy (ESWT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProlotherapyProcedure or surgery
Prolotherapy is an injection of a relatively small volume of an irritant or sclerosing solution at sites of painful ligament and/or tendon insertions, and in adjacent joint space over the course of several treatment sessions
Extracorporeal shock wave therapy (ESWT)Device
Extracorporeal shock wave therapy (ESWT), a kind of physical modalities, generating acoustic pulses, that are high positive pressure amplitudes, subsequently transferring concentrated energy to small focal distant areas of 2-8 mm in diameter
| Study group | Role | What they receive |
|---|---|---|
| Prolotherapy | Experimental | Solution 3.6 mL of 25% dextrose and 0.4 mL xylocaine total 4.0 mL And Solution 3.5 mL of 15% dextrose and 0.8 mL xylocaine total 4.3 mL each site Injection interval week 0, 3 and 6 Ultrasound guided injection Injection into enthesis points Receives: Procedure: Prolotherapy |
| Extracorporeal shock wave therapy (ESWT) | Active comparator | ESWT Treatment interval week 0, 1 and 2 Energy intensity 0.20-0.25 mJ/mm2 per impulse Frequency 4-5 Hz for 2,000 shocks Receives: Device: Extracorporeal shock wave therapy (ESWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
Pain reduction VAS
Measured: Assessment at baseline, three weeks, six weeks, three months and six months after the end of the treatment
Secondary outcomes (2)
Function DASH score
Disabilities of the arm, shoulder and hand
Measured: Assessment at baseline, three weeks, six weeks, three months and six months after the end of the treatment
Shoulder ROM
Active range of motion:
Forward flexion Abduction Internal rotation External rotation
Active range of motion:
Forward flexion Abduction Internal rotation External rotation
Active range of motion:
Forward flexion Abduction Internal rotation External rotation
Measured: Assessment at baseline, three weeks, six weeks, three months and six months after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start10 Nov 2023
- Primary completion1 Sep 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Rotator Cuff TendinopathyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songsuda Roongsaiwatana, Mahidol University
- Investigators
- Songsuda Roongsaiwatana, M.D., Study director, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700746
- Sponsor's protocol ID
- COA.No.MURA2023/839
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hauser RA, Lackner JB, Steilen-Matias D, Harris DK. A Systematic Review of Dextrose Prolotherapy for Chronic Musculoskeletal Pain. Clin Med Insights Arthritis Musculoskelet Disord. 2016 Jul 7;9:139-59. doi: 10.4137/CMAMD.S39160. eCollection 2016.
PubMed 27429562Galasso O, Amelio E, Riccelli DA, Gasparini G. Short-term outcomes of extracorporeal shock wave therapy for the treatment of chronic non-calcific tendinopathy of the supraspinatus: a double-blind, randomized, placebo-controlled trial. BMC Musculoskelet Disord. 2012 Jun 6;13:86. doi: 10.1186/1471-2474-13-86.
PubMed 22672772
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dextrose Prolotherapy Compare With Extracorporeal Shock Wave Therapy in the Treatment of Chronic Rotator Cuff Tendinopathy
- ClinicalTrials.gov ID
- NCT06700746
- Acronym / sponsor ID
- COA.No.MURA2023/839
- Conditions
- Chronic Rotator Cuff Tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 22 Nov 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.
To compare the efficacy of dextrose solution injection with ESWT for pain reduction in rotator cuff tendinopathy.
Additionally, secondary objective is to evaluate DASH and active range of motion of shoulder joint
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolotherapy | Experimental | Procedure: ProlotherapySolution 3.6 mL of 25% dextrose and 0.4 mL xylocaine total 4.0 mL And Solution 3.5 mL of 15% dextrose and 0.8 mL xylocaine total 4.3 mL each site Injection interval week 0, 3 and 6 Ultrasound guided injection Injection into enthesis points |
| Extracorporeal shock wave therapy (ESWT) | Active comparator | Device: Extracorporeal shock wave therapy (ESWT)ESWT Treatment interval week 0, 1 and 2 Energy intensity 0.20-0.25 mJ/mm2 per impulse Frequency 4-5 Hz for 2,000 shocks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic shoulder pain for at least 3 months
- Unilateral affected side
- History of unsuccessful conservative treatment
- Age 18 years or older
Key exclusion criteria (8 listed)
- Rotator cuff complete tear
- Local or generalized arthritis
- Previous shoulder surgery
- Previous history allergy to local anesthesia
- Pregnancy
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 |
|---|---|---|
| ProlotherapyProlotherapy is an injection of a relatively small volume of an irritant or sclerosing solution at sites of painful ligament and/or tendon insertions, and in adjacent joint space over the course of several treatment sessions | Procedure or surgery | Prolotherapy |
| Extracorporeal shock wave therapy (ESWT)Extracorporeal shock wave therapy (ESWT), a kind of physical modalities, generating acoustic pulses, that are high positive pressure amplitudes, subsequently transferring concentrated energy to small focal distant areas of 2-8 mm in diameter | Device | Extracorporeal shock wave therapy (ESWT) |
Primary outcome
VAS score
Time frame: Assessment at baseline, three weeks, six weeks, three months and six months after the end of the treatment
Pain reduction VAS
2 secondary outcomes
Function DASH score
Time frame: Assessment at baseline, three weeks, six weeks, three months and six months after the end of the treatment
Shoulder ROM
Time frame: Assessment at baseline, three weeks, six weeks, three months and six months after the end of the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Background: PubMed 27429562Hauser RA, Lackner JB, Steilen-Matias D, Harris DK. A Systematic Review of Dextrose Prolotherapy for Chronic Musculoskeletal Pain. Clin Med Insights Arthritis Musculoskelet Disord. 2016 Jul 7;9:139-59. doi: 10.4137/CMAMD.S39160. eCollection 2016.
- Background: PubMed 22672772Galasso O, Amelio E, Riccelli DA, Gasparini G. Short-term outcomes of extracorporeal shock wave therapy for the treatment of chronic non-calcific tendinopathy of the supraspinatus: a double-blind, randomized, placebo-controlled trial. BMC Musculoskelet Disord. 2012 Jun 6;13:86. doi: 10.1186/1471-2474-13-86.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Songsuda Roongsaiwatana, M.D. study director
Ramathibodi 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 Prolotherapy and Extracorporeal shock wave therapy (ESWT) in people with Chronic Rotator Cuff Tendinopathy, run by Mahidol University at 1 site in Thailand.
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 4 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: finished, as of the sponsor's last update on 22 Nov 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 Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score (time frame: Assessment at baseline, three weeks, six weeks, three months and six months after the end of the treatment). 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 NCT06700746, which also lists 2 linked publications.
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 22 Nov 2024.