Prolotherapy for the Treatment of Partial Rotator Cuff Tears

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hadassah Medical Organization
• Treatments: Cortisone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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