Overview

This trial is active, not recruiting.

Condition osteoarthritis
Treatments dextrose prolotherapy, saline prolotherapy, at-home physical therapy exercise group
Phase phase 1/phase 2
Sponsor University of Wisconsin, Madison
Collaborator National Center for Complementary and Integrative Health (NCCIH)
Start date July 2004
End date November 2008
Trial size 111 participants
Trial identifier NCT00085722, H-2004-0112, K23AT001879-01

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Subjects in Group 1 receive PrT with 15% and 25% dextrose solution, as it is generally practiced in the US today.
dextrose prolotherapy Dextrose
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.
(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.
saline prolotherapy Saline
7 mL 9% 'normal' saline and 3mL 1% lidocaine
(Other)
At-home physical therapy exercises as a non-injection control
at-home physical therapy exercise group Exercise
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

Primary Outcomes

Measure
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

Measure
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.

Eligibility Criteria

Male or female participants from 40 years up to 70 years old.

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

Additional Information

Official title The Efficacy of Prolotherapy in Osteoarthritic Knee Pain
Principal investigator David P. Rabago, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.