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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00085722 |
The purpose of this study is to determine whether prolotherapy (PrT), a therapy based on injection of a sugar solution in and around the knee, can decrease pain and disability from knee osteoarthritis (OA).
Condition | Intervention | Phase |
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Osteoarthritis |
Procedure: Dextrose Prolotherapy Procedure: Saline Prolotherapy Other: At-home physical therapy exercise group |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The Efficacy of Prolotherapy in Osteoarthritic Knee Pain |
Estimated Enrollment: | 111 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Subjects in Group 1 receive PrT with 15% and 25% dextrose solution, as it is generally practiced in the US today.
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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.
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2: Placebo Comparator
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.
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Procedure: Saline Prolotherapy
7 mL 9% 'normal' saline and 3mL 1% lidocaine
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3
At-home physical therapy exercises as a non-injection control
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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
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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. 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. At study completion, participants who did not receive PrT will have the option to receive up to five sessions of PrT at no cost. Enrollment is limited to residents of Southern Wisconsin.
Ages Eligible for Study: | 40 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | University of Wisconsin Department of Family Medicine ( David Rabago, MD Assistant Professor ) |
Study ID Numbers: | K23 AT001879-01 |
Study First Received: | June 14, 2004 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00085722 |
Health Authority: | United States: Federal Government |
Injection Therapy |
Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis |
Lidocaine Pain Rheumatic Diseases |