The Efficacy of Prolotherapy in Osteoarthritic Knee Pain
Dextrose Prolotherapy
+ Saline Prolotherapy
+ At-home physical therapy exercise group
Arthritis+2
+ Joint Diseases
+ Musculoskeletal Diseases
Treatment Study
Summary
Study start date: July 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.98 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 40 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Pain from knee osteoarthritis that has impacted life for 3 months to 10 years * X-ray results indicating knee osteoarthritis Exclusion Criteria: * Knee osteoarthritis surgical candidate * History of total knee joint repair * Prior use of PrT * Prior fracture of the knee joint * Joint injection of steroids or other drugs within the past 3 months * Rheumatoid or inflammatory arthritis * Chronic use of narcotic medication * Other chronic pain diagnoses * diabetes mellitus * Body mass index (BMI) greater than 45 * Unresolved litigation * Pregnancy * Co-morbidity that may interfere with the study
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboGroup III
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
University of Wisconsin General Clinical Research Center
Madison, United States