Joint Injections for Osteoarthritic Knee Pain

University of Wisconsin (UW)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Osteoarthritis

Treatments: Other: At-home physical therapy exercise group; Procedure: Saline Prolotherapy; Procedure: Dextrose Prolotherapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00085722

H-2004-0112

K23AT001879-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 98 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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98 participants in 3 patient groups, including a placebo group

Dextrose

Experimental group

Description:

Subjects in Group 1 receive PrT with 15% and 25% dextrose solution, as it is generally practiced in the US today.

Treatment:

Procedure: Dextrose Prolotherapy

Normal saline

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Saline Prolotherapy

Exercise

Other group

Description:

At-home physical therapy exercises as a non-injection control

Treatment:

Other: At-home physical therapy exercise group