Prolotherapy for the Treatment of Partial Rotator Cuff Tears

NCT04062838 | Withdrawn Phase 4

• 1 other identifier: 0391-18-HMO
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Rotator Cuff Tear

Keywords

partial; prolotherapy; subacromial steroid injection; tendon healing; tendon tear enlargement

Outcome Measures

Primary Outcomes (4)

• 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

  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.

  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

  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

  6 and 12 months after the last treatment

Study Arms (1)

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.

Drug: Dextrose 50

Interventions

Dextrose 50 DRUG

As above

Also known as: Glucose 50% solution

Prolotherapy

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Pain Unit, Hadassah Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Glucose; Solutions

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: evaluating radiologist will all be blinded to the dates of the scans.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 20, 2019
• Study Start: August 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: August 23, 2022

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)