Joint Injections for Osteoarthritic Knee Pain
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 40 - 70 |
| Updated: | 2/17/2019 |
| Start Date: | July 2004 |
| End Date: | May 1, 2016 |
The Efficacy of Prolotherapy in Osteoarthritic Knee Pain
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).
injection of a sugar solution in and around the knee, can decrease pain and disability from
knee osteoarthritis (OA).
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.
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.
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
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