Joint Injections for Osteoarthritic Knee Pain
|Osteoarthritis||Procedure: Dextrose Prolotherapy Procedure: Saline Prolotherapy Other: At-home physical therapy exercise group||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Efficacy of Prolotherapy in Osteoarthritic Knee Pain|
- Quality of life, pain scores and disability at wks 0, 5, 9, 12, 24, 52 [ Time Frame: Participants will be followed for one year. ]
- Secondary outcomes include disease and general quality of life indicators (all subjects) and magnetic resonance image (in a subset of 37 subjects). [ Time Frame: Participants will be monitored for one year. ]
|Study Start Date:||July 2004|
|Estimated Study Completion Date:||May 2016|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Subjects in Group 1 receive PrT with 15% and 25% dextrose solution, as it is generally practiced in the US today.
Procedure: Dextrose Prolotherapy
Injection procedure: 50% dextrose is diluted with .9% 'normal' saline and 1% lidocaine to achieve 15% dextrose for ligament injections and 25% dextrose for intra-articular injection.
Other Name: Dextrose
Placebo Comparator: Normal saline
Subjects in Group 2 will receive the same treatment as Group 1, except that a 0.9% 'normal' saline solution with no known benefit will be used instead of dextrose.
Procedure: Saline Prolotherapy
7 mL 9% 'normal' saline and 3mL 1% lidocaine
Other Name: Saline
At-home physical therapy exercises as a non-injection control
Other: At-home physical therapy exercise group
Subjects in the at-home physical therapy exercise group will receive a patient information pamphlet about knee osteoarthritis and conservative care instructions for standard at-home physical therapy exercises
Other Name: Exercise
OA is a common, debilitating condition for which there is no cure and no known cause. Prolotherapy (PrT) is an injection-based therapy for chronic musculoskeletal pain in which an irritant solution is injected at painful ligaments and tendons to produce stronger connective tissue and decrease pain. Although limited studies suggest PrT is effective may be effective for low back pain, its use has not been rigorously studied in human clinical trials for osteoarthritis.
Participants in this study will be randomly assigned to receive one of three treatments: standard PrT, injections with a saline placebo, or a pamphlet with recommendations for home knee physical therapy. Injections will be given at Weeks 1, 5, and 9; injection group subjects will have the option to receive an additional 2 sets of injections. All participants will be assessed for a total of 1 year. A set of disease-specific and general quality-of-life questionnaires will be used to assess participants' outcomes . A randomized subset of participants (N=38)will receive magnetic resonance imaging (MRI)of the knee at baseline and 52 weeks. At study completion, participants who did not receive PrT will have the option to receive up to five sessions of PrT at no cost. Data will be collected for this group (minus MRI) and will be analyzed separately. Enrollment is limited to residents of Southern Wisconsin.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00085722
|United States, Wisconsin|
|Northeast Family Medical Center|
|Madison, Wisconsin, United States, 53704|
|University of Wisconsin General Clinical Research Center|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||David P. Rabago, MD||University of Wisconsin Dept of Family Medicine|