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Joint Injections for Osteoarthritic Knee Pain

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ClinicalTrials.gov Identifier: NCT00085722
Recruitment Status : Completed
First Posted : June 16, 2004
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE June 14, 2004
First Posted Date  ICMJE June 16, 2004
Last Update Posted Date February 15, 2019
Study Start Date  ICMJE July 2004
Actual Primary Completion Date November 1, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2007)
Quality of life, pain scores and disability at wks 0, 5, 9, 12, 24, 52 [ Time Frame: Participants will be followed for one year. ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2012)
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. ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Joint Injections for Osteoarthritic Knee Pain
Official Title  ICMJE The Efficacy of Prolotherapy in Osteoarthritic Knee Pain
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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • 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
  • Procedure: Saline Prolotherapy
    7 mL 9% 'normal' saline and 3mL 1% lidocaine
    Other Name: Saline
  • 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
Study Arms  ICMJE
  • Experimental: Dextrose
    Subjects in Group 1 receive PrT with 15% and 25% dextrose solution, as it is generally practiced in the US today.
    Intervention: Procedure: Dextrose Prolotherapy
  • 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.
    Intervention: Procedure: Saline Prolotherapy
  • Exercise
    At-home physical therapy exercises as a non-injection control
    Intervention: Other: At-home physical therapy exercise group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2019)
98
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
111
Actual Study Completion Date  ICMJE May 1, 2016
Actual Primary Completion Date November 1, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00085722
Other Study ID Numbers  ICMJE H-2004-0112
K23AT001879-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: David P. Rabago, MD University of Wisconsin Dept of Family Medicine
PRS Account University of Wisconsin, Madison
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP