Rotator Cuff TearPhase 4NCT04062838
Prolotherapy for the Treatment of Partial Rotator Cuff Tears
A Phase 4 study testing Dextrose 50 in people with Rotator Cuff Tear, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
This is a Prospective Pilot Single Arm study on prolotherapy for the treatment of patients with pain due to Partial Rotator Cuff (RC) Tears of the Shoulder. The aim of this trial is to study the effects of injected glucose on injured or degenerative RC tears of the shoulder. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Dextrose 50
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2020to 1 Dec 2022
- Phase
- Phase 4
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With partial rotator cuff tears of either the supraspinatus, infraspinatus or subscapularis tendons of less than 1cm in either length or width
- With pain lasting more than 6 months
- Pain with an NRS score of at least 6 out of 10
Who cannot join
- Who had surgical repair, arthroscopy of the affected shoulder
- With rotator cuff tears larger than 1cm
- With Rotator cuff arthropathy or osteoarthritis of the glenohumeral joint
- With primary adhesive capsulitis (frozen shoulder secondary to partial RC tear is not an exclusion criterion)
- With active malignant disease
- With fibromyalgia or depression, the latter significant enough to affect their daily life
Show all 16Show fewer
- With a history of inflammatory joint disease
- With localized (to the involved arm) or generalised neuropathic pain
- With a history of bone fracture within the shoulder girdle which is still causing pain
- Currently medicated with corticosteroids
- With active infection
- Who smoke either tobacco or cannabis
- Who are pregnant
- With uncontrolled diabetes
- Who have any contra-indication to having an MRI scan.
- Absolute contra-indications to having an MRI scan include any shrapnel in the brain or eye in particular and certain cardiac valves and pacemakers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Pilot Study: Prolotherapy For The Treatment Of Patients With Partial Rotator Cuff Tears
This is a Prospective Pilot Single Arm study on prolotherapy for the treatment of patients with pain due to Partial Rotator Cuff (RC) Tears of the Shoulder.
The aim of this trial is to study the effects of injected glucose on injured or degenerative RC tears of the shoulder. Glucose is not recognized by the FDA for this purpose but is used in 2 main concentrations: 50% solution to treat hypoglycemia and 5% solution for fluid replacement.
In the prolotherapy group, 20% dextrose will be injected into 4 locations of the affected shoulder. In the active control group, patients will receive a single injection of methylprednisolone into the subacromial bursa and 3 saline injections overlying the tendons.
Read the detailed description
Prolotherapy treatments have been used since the 1950s for the treatment of weakened or damaged soft tissue and cartilage. Pre-clinical studies have demonstrated an anabolic response leading to thickened collagen tissue following treatment. Prolotherapy has been used to treat various tendinopathies, non-specific low back pain whiplash injuries, and partial ligament and tendon tears. Injection solutions used in the past include P2G (phenol, glycerine and glucose), sodium morrhuate and simple dextrose. Today, most prolotherapists use simple dextrose as an off-label treatment. Current treatment methods of the RC have several short-comings. Steroid injections, the most commonly applied treatment today for RC tears, have a short term benefit at the very most and have been found, when repeated, to lead to deterioration in pain, function and even tendon structure. Surgery is expensive, requires a long rehabilitation program, and has a very significant re-tear rate. In addition, studies are not conclusive regarding its effectiveness as compared to conservative treatment for the treatment of RC tears. No prolotherapy studies have been performed in the treatment of partial RC tears. Considering the extent of this endemic disorder, it was decided to explore prolotherapy for the treatment of partial rotator cuff tears.
- Patients will be referred from local community clinics both by orthopedic surgeons as well as from family physicians. Patients will have received a steroid injection into the subacromial bursa and will have failed to respond.
Patients will receive 3 monthly treatments all under ultrasound.
25 patients will be recruited to this Pilot study. It is impossible to make an accurate estimation of the sample size of the trial needed as no prolotherapy study has been done specifically on partial RC tears.
- Patients with partial tears of less than 1 cm measured in a thorough ultrasound examination either in length or in width in any of the rotator cuff tendons are eligible for the trial.
- Patients will sign a consent form. They will rate their pain NRS score out of 10 prior to treatment and fill out (hopefully) an Oxford Shoulder Score (OSS) Questionnaire. (The principle investigator has translated this questionnaire into Hebrew and has received approval from Oxford University for use in this research).
- Dr. Wende will perform all treatments under ultrasound in both groups, up to 3 treatments in each patient.
- The radiologist evaluating pre and post treatment ultrasound scans will be blinded to the dates of the exam.
- Before the first treatment, an ultrasound scan of the shoulder will be performed by a musculoskeletal radiologist in Hadassah.
- 4 points within the shoulder will be injected. Structures to be injected will include the supraspinatus, infraspinatus and subscapularis tendons as well as the inferior glenohumeral ligament. 20% dextrose and 0.5% lidocaine will be injected.
- All patients will be followed up by an unbiased, independent investigator 1, 6 and 12 months after the last treatment at which time the NRS pain score is questioned and an OSS questionnaire is filled out.
- 6 months after the last treatment, patients will have a repeat ultrasound scan of the shoulder 6 and 12 months after the last treatment, the range of shoulder motion will be examined by an independent investigator.
- Conditions
- Rotator Cuff Tear
- Being tested
- Dextrose 50
- Keywords
- partial, prolotherapy, subacromial steroid injection, tendon healing, tendon tear enlargement
- 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.
Dextrose 50Drug
Also called Glucose 50% solution
As above
| Study group | Role | What they receive |
|---|---|---|
| Prolotherapy | Experimental | Injection of 20% dextrose (50 % dextrose diluted with 0.5% lidocaine) into the rotator cuff tendinous insertions as well as into the tear. All injections are performed under ultrasound. Receives: Drug: Dextrose 50 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Score (NRS) pain score: change in pain score over a follow-up period of 12 months: change in pain ratings as compared to pre-treatment ratings.
This is the pain score the patient estimates he or she suffers from between 0 and 10. This is the pain score the patient estimates he or she suffers from between 0 and 10. An independent investigator contacts patients during the follow-up period and questions them about pain and function
Measured: At 3 points during the 12 month follow-up: 1, 6 and 12 months after the last treatment
Oxford Shoulder Score (OSS): change in function during a follow-up of 12 months as compared to pre-treatment scores
This is a questionnaire evaluating function that may or may not be affected specifically by the affected shoulder.
Measured: At 3 points during the 12 month follow-up: 1, 6 and 12 months after the last treatment
Tear size as measured on MRI scanning
Measurement of tear size on the MRI scan. The MRI scans are read by a musculoskeletal radiologist who is blinded to the treatment arm
Measured: 6 after the last treatment
Range of motion: change in range of motion over a period of 12 months as compared to pre-treatment scores.
Examination of passive range of motion of the shoulder. This is done by an independent researcher who is blinded to the treatment arm
Measured: 6 and 12 months after the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start1 Aug 2020 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2022 (estimated)
Why it stopped: I did not receive funding to finance this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The aim of this trial is to study the effects of injected glucose on injured or degenerative rotator cuff tears of the shoulder. Glucose is not recognised by the FDA for this purpose but is used in 2 main concentrations: 50% solution to treat hypoglycemia and 5% solution for fluid replacement.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062838
- Sponsor's protocol ID
- 0391-18-HMO
- Status last verified
- May 2020
- First submitted
- 1 Aug 2018
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Study: Prolotherapy For The Treatment Of Patients With Partial Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT04062838
- Acronym / sponsor ID
- 0391-18-HMO
- Conditions
- Rotator Cuff Tear
- Keywords
- partial, prolotherapy, subacromial steroid injection, tendon healing, tendon tear enlargement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: I did not receive funding to finance this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 20 Aug 2019 (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 is a Prospective Pilot Single Arm study on prolotherapy for the treatment of patients with pain due to Partial Rotator Cuff (RC) Tears of the Shoulder.
The aim of this trial is to study the effects of injected glucose on injured or degenerative RC tears of the shoulder. Glucose is not recognized by the FDA for this purpose but is used in 2 main concentrations: 50% solution to treat hypoglycemia and 5% solution for fluid replacement.
In the prolotherapy group, 20% dextrose will be injected into 4 locations of the affected shoulder. In the active control group, patients will receive a single injection of methylprednisolone into the subacromial bursa and 3 saline injections overlying the tendons.
Detailed description
Prolotherapy treatments have been used since the 1950s for the treatment of weakened or damaged soft tissue and cartilage. Pre-clinical studies have demonstrated an anabolic response leading to thickened collagen tissue following treatment. Prolotherapy has been used to treat various tendinopathies, non-specific low back pain whiplash injuries, and partial ligament and tendon tears. Injection solutions used in the past include P2G (phenol, glycerine and glucose), sodium morrhuate and simple dextrose. Today, most prolotherapists use simple dextrose as an off-label treatment. Current treatment methods of the RC have several short-comings. Steroid injections, the most commonly applied treatment today for RC tears, have a short term benefit at the very most and have been found, when repeated, to lead to deterioration in pain, function and even tendon structure. Surgery is expensive, requires a long rehabilitation program, and has a very significant re-tear rate. In addition, studies are not conclusive regarding its effectiveness as compared to conservative treatment for the treatment of RC tears. No prolotherapy studies have been performed in the treatment of partial RC tears. Considering the extent of this endemic disorder, it was decided to explore prolotherapy for the treatment of partial rotator cuff tears.
- Patients will be referred from local community clinics both by orthopedic surgeons as well as from family physicians. Patients will have received a steroid injection into the subacromial bursa and will have failed to respond.
Patients will receive 3 monthly treatments all under ultrasound.
25 patients will be recruited to this Pilot study. It is impossible to make an accurate estimation of the sample size of the trial needed as no prolotherapy study has been done specifically on partial RC tears.
- Patients with partial tears of less than 1 cm measured in a thorough ultrasound examination either in length or in width in any of the rotator cuff tendons are eligible for the trial.
- Patients will sign a consent form. They will rate their pain NRS score out of 10 prior to treatment and fill out (hopefully) an Oxford Shoulder Score (OSS) Questionnaire. (The principle investigator has translated this questionnaire into Hebrew and has received approval from Oxford University for use in this research).
- Dr. Wende will perform all treatments under ultrasound in both groups, up to 3 treatments in each patient.
- The radiologist evaluating pre and post treatment ultrasound scans will be blinded to the dates of the exam.
- Before the first treatment, an ultrasound scan of the shoulder will be performed by a musculoskeletal radiologist in Hadassah.
- 4 points within the shoulder will be injected. Structures to be injected will include the supraspinatus, infraspinatus and subscapularis tendons as well as the inferior glenohumeral ligament. 20% dextrose and 0.5% lidocaine will be injected.
- All patients will be followed up by an unbiased, independent investigator 1, 6 and 12 months after the last treatment at which time the NRS pain score is questioned and an OSS questionnaire is filled out.
- 6 months after the last treatment, patients will have a repeat ultrasound scan of the shoulder 6 and 12 months after the last treatment, the range of shoulder motion will be examined by an independent investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The aim of this trial is to study the effects of injected glucose on injured or degenerative rotator cuff tears of the shoulder. Glucose is not recognised by the FDA for this purpose but is used in 2 main concentrations: 50% solution to treat hypoglycemia and 5% solution for fluid replacement.
| Arm | Type | Receives |
|---|---|---|
| Prolotherapy | Experimental | Drug: Dextrose 50Injection of 20% dextrose (50 % dextrose diluted with 0.5% lidocaine) into the rotator cuff tendinous insertions as well as into the tear. All injections are performed under ultrasound. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- With partial rotator cuff tears of either the supraspinatus, infraspinatus or subscapularis tendons of less than 1cm in either length or width
- With pain lasting more than 6 months
- Pain with an NRS score of at least 6 out of 10
Key exclusion criteria (16 listed)
- Who had surgical repair, arthroscopy of the affected shoulder
- With rotator cuff tears larger than 1cm
- With Rotator cuff arthropathy or osteoarthritis of the glenohumeral joint
- With primary adhesive capsulitis (frozen shoulder secondary to partial RC tear is not an exclusion criterion)
- With active malignant disease
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 |
|---|---|---|
| Dextrose 50Also: Glucose 50% solutionAs above | Drug | Prolotherapy |
Primary outcome
Numerical Rating Score (NRS) pain score: change in pain score over a follow-up period of 12 months: change in pain ratings as compared to pre-treatment ratings.
Time frame: At 3 points during the 12 month follow-up: 1, 6 and 12 months after the last treatment
This is the pain score the patient estimates he or she suffers from between 0 and 10. This is the pain score the patient estimates he or she suffers from between 0 and 10. An independent investigator contacts patients during the follow-up period and questions them about pain and function
Oxford Shoulder Score (OSS): change in function during a follow-up of 12 months as compared to pre-treatment scores
Time frame: At 3 points during the 12 month follow-up: 1, 6 and 12 months after the last treatment
This is a questionnaire evaluating function that may or may not be affected specifically by the affected shoulder.
Tear size as measured on MRI scanning
Time frame: 6 after the last treatment
Measurement of tear size on the MRI scan. The MRI scans are read by a musculoskeletal radiologist who is blinded to the treatment arm
Range of motion: change in range of motion over a period of 12 months as compared to pre-treatment scores.
Time frame: 6 and 12 months after the last treatment
Examination of passive range of motion of the shoulder. This is done by an independent researcher who is blinded to the treatment arm
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dextrose 50 in people with Rotator Cuff Tear, run by Hadassah Medical Organization at 1 site in Israel.
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 16 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: withdrawn, as of the sponsor's last update on 23 Aug 2022. 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 Israel. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Numerical Rating Score (NRS) pain score: change in pain score over a follow-up period of 12 months: change in pain ratings as compared to pre-treatment ratings. (time frame: At 3 points during the 12 month follow-up: 1, 6 and 12 months after the last treatment). The study lists 4 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 23 Aug 2022.