Clinical Trial: Joint Injections for Osteoarthritic Knee Pain

This study is currently recruiting patients.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)

Purpose

The purpose of this study is to determine whether prolotherapy, a therapy based on injection of a sugar solution in and around the knee, can decrease pain and disability from knee osteoarthritis (OA).

Condition Treatment or Intervention Phase
Osteoarthritis
 Procedure: Prolotherapy
Phase I
Phase II

MedlinePlus related topics:  Osteoarthritis

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title: The Efficacy of Prolotherapy in Osteoarthritic Knee Pain

Further Study Details: 

Expected Total Enrollment:  111

Study start: July 2004;  Expected completion: November 2008

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 studies indicate the PrT is effective, its use has not been rigorously studied in human clinical trials.

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; participants will then be monitored for 1 year. A quality of life questionnaire and a pain survey will be used to assess participants. At study completion, participants who did not receive PrT will have the option to receive three sessions of PrT at no cost.

Eligibility

Ages Eligible for Study:  40 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Pain from knee osteoarthritis that has impacted life for 3 to 18 months
  • 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 40
  • Unresolved litigation
  • Pregnancy
  • Co-morbidity that may interfere with the study

Location and Contact Information

Jessica M. Grettie, BS      608-265-4200    jgrettie@fammed.wisc.edu
David P. Rabago, MD      608-265-2487    David.Rabago@fammed.wisc.edu

Wisconsin
      Northeast Family Medical Center, Madison,  Wisconsin,  53704,  United States; Recruiting
David P. Rabago, MD  608-265-2487    david.rabago@fammed.wisc.edu 
Jessica M. Grettie, BS  608-265-4200    jgrettie@fammed.wisc.edu 
David P. Rabago, MD,  Principal Investigator
Jeffery Patterson, MD,  Sub-Investigator

      University of Wisconsin General Clinical Research Center, Madison,  Wisconsin,  53792,  United States; Recruiting
David P. Rabago, MD  608-265-2487    david.rabago@fammed.wisc.edu 
Jessica M. Grettie, BS  608-265-4200    jgrettie@fammed.wisc.edu 
David P. Rabago, MD,  Principal Investigator
Jeffery Patterson, MD,  Sub-Investigator

Study chairs or principal investigators

David P. Rabago, MD,  Principal Investigator,  University of Wisconsin Dept of Family Medicine   

More Information

University of Wisconsin Department of Family Medicine Web Site

Publications

Rejeski WJ, Ettinger WH Jr, Shumaker S, Heuser MD, James P, Monu J, Burns R. The evaluation of pain in patients with knee osteoarthritis: the knee pain scale. J Rheumatol. 1995 Jun;22(6):1124-9.

Reeves KD, Hassanein K. Randomized, prospective, placebo-controlled double-blind study of dextrose prolotherapy for osteoarthritic thumb and finger (DIP, PIP, and trapeziometacarpal) joints: evidence of clinical efficacy. J Altern Complement Med. 2000 Aug;6(4):311-20.

Eberle E, Ottillinger B. Clinically relevant change and clinically relevant difference in knee osteoarthritis. Osteoarthritis Cartilage. 1999 Sep;7(5):502-3. No abstract available.

Klein RG, Eek BC, DeLong WB, Mooney V. A randomized double-blind trial of dextrose-glycerine-phenol injections for chronic, low back pain. J Spinal Disord. 1993 Feb;6(1):23-33.

Ongley MJ, Klein RG, Dorman TA, Eek BC, Hubert LJ. A new approach to the treatment of chronic low back pain. Lancet. 1987 Jul 18;2(8551):143-6.

Dechow E, Davies RK, Carr AJ, Thompson PW. A randomized, double-blind, placebo-controlled trial of sclerosing injections in patients with chronic low back pain. Rheumatology (Oxford). 1999 Dec;38(12):1255-9.

Yelland MJ, Glasziou PP, Bogduk N, Schluter PJ, McKernon M. Prolotherapy injections, saline injections, and exercises for chronic low-back pain: a randomized trial. Spine. 2004 Jan 1;29(1):9-16; discussion 16.

Reeves KD, Hassanein K. Randomized prospective double-blind placebo-controlled study of dextrose prolotherapy for knee osteoarthritis with or without ACL laxity. Altern Ther Health Med. 2000 Mar;6(2):68-74, 77-80.

Rogers WH, Wittink H, Wagner A, Cynn D, Carr DB. Assessing individual outcomes during outpatient multidisciplinary chronic pain treatment by means of an augmented SF-36. Pain Med. 2000 Mar;1(1):44-54.

Study ID Numbers:  1-K23-AT001879-01
Record last reviewed:  January 2005
Last Updated:  January 19, 2005
Record first received:  June 14, 2004
ClinicalTrials.gov Identifier:  NCT00085722
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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