Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis
|ClinicalTrials.gov Identifier: NCT00685880|
Recruitment Status : Terminated (Unable to recruit adequate numbers of patients)
First Posted : May 29, 2008
Results First Posted : August 30, 2012
Last Update Posted : August 30, 2012
|Condition or disease||Intervention/treatment|
|Thumb Carpometacarpal Joint Osteoarthritis||Drug: Prolotherapy (10% dextrose solution) Drug: Betamethasone|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Randomized, Double Blind Comparison Trial of Prolotherapy (Dextrose) Compared to Corticosteroid Injection for the Treatment of Symptomatic Thumb Carpo-metacarpal Joint Arthritis|
|Study Start Date :||May 2008|
|Primary Completion Date :||July 2010|
|Study Completion Date :||July 2010|
Experimental: Prolotherapy group
Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
Drug: Prolotherapy (10% dextrose solution)
Dextrose diluted with sterile water.
Active Comparator: Corticosteroid Group
Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
CELESTONE® SOLUSPAN® * (betamethasone injectable suspension) Injectable Suspension is a sterile aqueous suspension containing 3 mg per milliliter betamethasone, as betamethasone sodium phosphate, and 3 mg per milliliter betamethasone acetate. Subjects will receive a 0.25 to 0.5 mL Celestone Soluspan injection.
Other Name: Celestone Soluspan
- Number of Participants With a Decreased Pain Score >20% [ Time Frame: baseline, 6 month follow-up ]Pain was measured on a 10 point visual analogue scale (VAS), with 0 meaning no pain, and 10 meaning extreme pain.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00685880
|United States, Minnesota|
|Rochester, Minnesota, United States, 55902|
|Principal Investigator:||Michael J. Gruba, M.D.||Mayo Clinic Physical Medicine & Rehabilitation Residency|