Status:
WITHDRAWN
Prolotherapy for the Treatment of Partial Rotator Cuff Tears
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Rotator Cuff Tear
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
Brief 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 effe...
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 thicke...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04062838
Start Date
August 1 2020
End Date
December 1 2022
Last Update
August 23 2022
Active Locations (1)
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1
Pain Unit, Hadassah Medical Center
Jerusalem, Israel