Completed

The Efficacy of Prolotherapy in Osteoarthritic Knee Pain

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What is being tested

Dextrose Prolotherapy

+ Saline Prolotherapy

+ At-home physical therapy exercise group

ProcedureOther
Who is being recruted

Arthritis+2

+ Joint Diseases

+ Musculoskeletal Diseases

From 40 to 70 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1 & 2
Interventional
Study Start: July 2004
See protocol details

Summary

Principal SponsorUniversity of Wisconsin, Madison
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleThe Efficacy of Prolotherapy in Osteoarthritic Knee Pain 
NCT00085722
Principal SponsorUniversity of Wisconsin, Madison
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

98 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

ArthritisJoint DiseasesMusculoskeletal DiseasesOsteoarthritisRheumatic Diseases

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.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

Placebo
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.

Group III

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

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

Suspended

Northeast Family Medical Center

Madison, United StatesSee the location
Suspended

University of Wisconsin General Clinical Research Center

Madison, United States
Completed2 Study Centers