The purpose of this study is to determine whether prolotherapy, a therapy based on injection of a sugar solution in and around the knee, can decrease pain and disability from knee osteoarthritis (OA).

Official Title

The Efficacy of Prolotherapy in Osteoarthritic Knee Pain

Conditions

-Treatment or Intervention Phase -Osteoarthritis-Procedure: Prolotherapy-Phase I-Phase II

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further Details

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 studies indicate the PrT is effective, its use has not been rigorously studied in human clinical trials. 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; participants will then be monitored for 1 year. A quality of life questionnaire and a pain survey will be used to assess participants. At study completion, participants who did not receive PrT will have the option to receive three sessions of PrT at no cost.

Study Start

Eligibility & Criteria

Ages Eligible for Study: 45 Years – 70 Years, Genders Eligible for Study: Both Criteria Inclusion Criteria:Pain from knee osteoarthritis that has impacted life for 3 to 18 months Normal x-ray results 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 40 Unresolved litigation Pregnancy Co-morbidity that may interfere with the study

Total Enrolment

111

Contact Details

[1] National Center for Complementary and Alternative Medicine (NCCAM)