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Completed

NCT Number: NCT00085722

Joint Injections for 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).

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Northeast Family Medical Center, Madison, Wisconsin, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dextrose prolotherapy

Procedure

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 names: Dextrose

Saline Prolotherapy

Procedure

7 mL 9% 'normal' saline and 3mL 1% lidocaine

Other names: Saline

At-home physical therapy exercise group

Other

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 names: Exercise

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

The Efficacy of Prolotherapy in Osteoarthritic Knee Pain

Important dates

Study start
2004
Primary completion
2008
Study completion
2016
First posted
Jun 16, 2004
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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