Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis
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|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||Phase|
|Thumb Carpometacarpal Joint Osteoarthritis||Drug: Prolotherapy (10% dextrose solution) Drug: Betamethasone||Not Applicable|
|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|
|Actual Primary Completion Date :||July 2010|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|