Status:
COMPLETED
Study of 25% Dextrose Injections in Shoulder Ligaments and Tendons to Promote Their Healing
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
WorkSafe BC
Conditions:
Rotator Cuff Tendinitis
Eligibility:
All Genders
19-74 years
Phase:
NA
Brief Summary
HYPOTHESIS: Prolotherapy, the injection of a growth promoting solution in injured ligaments and tendons of the shoulder is an effective treatment that decreases pain, increases functional capacity and...
Detailed Description
SAMPLE SIZE: Sample size justification: Dr. Bertrand reviewed 144 cases treated with prolotherapy, 25 of whom fit the inclusion criteria (between the ages of 19 and 74 and not suffering from arthritis...
Eligibility Criteria
Inclusion
- consecutive patients over 19 and less than 75 years of age
Exclusion
- allergy to corn, as the dextrose solution is corn-based
- allergy to local anesthetic
- immune deficiency
- conditions requiring anti-inflammatory medications including prednisone, corticosteroid injection less than eight weeks prior to the first set of injections
- use of immune suppressants
- symptomatic osteoarthritis of the gleno-humeral or acromio-clavicular joint
- age over 75 or under 19
- adhesive capsulitis based on a thorough physical examination, where shoulder flexion or abduction is below 100 °, horizontal adduction is below 30 °, the hand behind the back is below the waist, external rotation is less than 30 °
- full thickness tear greater than 1.2 cm as seen on ultrasound
- autoimmune disorders such as lupus or rheumatoid arthritis
- neurological disorders including Parkinson, seizures, and dementias are excluded for patient safety during the procedures
- HIV, viral hepatitis and other blood borne communicable diseases, to protect the investigators
- calcium deposits greater than 8 mm in diameter
- type III acromion as seen on x-ray
- painful condition elsewhere in the body likely to cloud the subject's assessment of his shoulder pain
- no evidence of tendinopathy as seen on ultrasound
- uncontrolled diabetes: A1C \> 7
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT01402011
Start Date
November 1 2010
End Date
June 1 2013
Last Update
August 14 2018
Active Locations (2)
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1
Dr. Helene Bertrand Inc., 220-1940 Lonsdale Avenue
North Vancouver, British Columbia, Canada, V7M 2K2
2
Active shoulder clinics, West Vancouver sports and orthopedic physiotherapy, 210- 575 16th Street
West Vancouver, British Columbia, Canada, V7V 4Y1