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Joint Injections for Osteoarthritic Knee Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00085722
Recruitment Status : Completed
First Posted : June 16, 2004
Last Update Posted : February 15, 2019
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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).

Condition or disease Intervention/treatment Phase
Osteoarthritis Procedure: Dextrose Prolotherapy Procedure: Saline Prolotherapy Other: At-home physical therapy exercise group Phase 1 Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Prolotherapy in Osteoarthritic Knee Pain
Study Start Date : July 2004
Actual Primary Completion Date : November 1, 2008
Actual Study Completion Date : May 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Dextrose
Subjects in Group 1 receive PrT with 15% and 25% dextrose solution, as it is generally practiced in the US today.
Procedure: Dextrose Prolotherapy
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.
Other Name: Dextrose

Placebo Comparator: Normal saline
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.
Procedure: Saline Prolotherapy
7 mL 9% 'normal' saline and 3mL 1% lidocaine
Other Name: Saline

At-home physical therapy exercises as a non-injection control
Other: At-home physical therapy exercise group
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
Other Name: Exercise

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00085722

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United States, Wisconsin
Northeast Family Medical Center
Madison, Wisconsin, United States, 53704
University of Wisconsin General Clinical Research Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: David P. Rabago, MD University of Wisconsin Dept of Family Medicine
Additional Information:
Hackett GS, Hemwall GA, Montgomery GA. Ligament and Tendon Relaxation Treated by Prolotherapy. Fifth Ed. ed. Oak Park: Gustav A. Hemwall, 1993
Linetsky FS, FRafael M,. Pain Management, 2002:381-402.
Dorman TA. Prolotherapy: A survey. The Journal of Orthopaedic Medicine 1993;15(2):49-50

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Wisconsin, Madison Identifier: NCT00085722    
Other Study ID Numbers: H-2004-0112
K23AT001879-01 ( U.S. NIH Grant/Contract )
First Posted: June 16, 2004    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Keywords provided by University of Wisconsin, Madison:
Injection Therapy
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases