Joint Injections for Osteoarthritic Knee Pain

NCT00085722 | Completed Phase 1 DMC

• 2 other identifiers: H-2004-0112K23AT001879-01
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 2

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).

Conditions

Osteoarthritis

Keywords

Injection Therapy

Outcome Measures

Primary Outcomes (1)

• Quality of life, pain scores and disability at wks 0, 5, 9, 12, 24, 52

  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).

  Participants will be monitored for one year.

Study Arms (3)

Dextrose

EXPERIMENTAL

Subjects in Group 1 receive PrT with 15% and 25% dextrose solution, as it is generally practiced in the US today.

Procedure: Dextrose Prolotherapy

Normal saline

PLACEBO COMPARATOR

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

Exercise

OTHER

At-home physical therapy exercises as a non-injection control

Other: At-home physical therapy exercise group

Interventions

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.

Also known as: Dextrose

Dextrose

Saline Prolotherapy PROCEDURE

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

Also known as: Saline

Normal 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

Also known as: Exercise

Exercise

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pain from knee osteoarthritis that has impacted life for 3 months to 10 years
• X-ray results indicating knee osteoarthritis

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (2)

Northeast Family Medical Center

Madison, Wisconsin, 53704, United States

Location

University of Wisconsin General Clinical Research Center

Madison, Wisconsin, 53792, United States

Location

Related Publications (15)

• 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.

  PMID: 7674241 BACKGROUND

• 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. doi: 10.1089/10755530050120673.

  PMID: 10976977 BACKGROUND

• Eberle E, Ottillinger B. Clinically relevant change and clinically relevant difference in knee osteoarthritis. Osteoarthritis Cartilage. 1999 Sep;7(5):502-3. doi: 10.1053/joca.1999.0246. No abstract available.

  PMID: 10489324 BACKGROUND

• 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.

  PMID: 8439713 BACKGROUND

• 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. doi: 10.1016/s0140-6736(87)92340-3.

  PMID: 2439856 BACKGROUND

• 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. doi: 10.1093/rheumatology/38.12.1255.

  PMID: 10587555 BACKGROUND

• 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 (Phila Pa 1976). 2004 Jan 1;29(1):9-16; discussion 16. doi: 10.1097/01.BRS.0000105529.07222.5B.

  PMID: 14699269 BACKGROUND

• Hackett GS, Hemwall GA, Montgomery GA. Ligament and Tendon Relaxation Treated by Prolotherapy. Fifth Ed. ed. Oak Park: Gustav A. Hemwall, 1993

  BACKGROUND

• Linetsky FS, FRafael M,. Pain Management, 2002:381-402.

  BACKGROUND

• Dorman TA. Prolotherapy: A survey. The Journal of Orthopaedic Medicine 1993;15(2):49-50

  BACKGROUND

• 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.

  PMID: 10710805 BACKGROUND

• 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. doi: 10.1046/j.1526-4637.2000.99102.x.

  PMID: 15101963 BACKGROUND

• Rabago D, Patterson JJ, Mundt M, Zgierska A, Fortney L, Grettie J, Kijowski R. Dextrose and morrhuate sodium injections (prolotherapy) for knee osteoarthritis: a prospective open-label trial. J Altern Complement Med. 2014 May;20(5):383-91. doi: 10.1089/acm.2013.0225. Epub 2014 Mar 17.

  PMID: 24635447 DERIVED

• Rabago D, Patterson JJ, Mundt M, Kijowski R, Grettie J, Segal NA, Zgierska A. Dextrose prolotherapy for knee osteoarthritis: a randomized controlled trial. Ann Fam Med. 2013 May-Jun;11(3):229-37. doi: 10.1370/afm.1504.

  PMID: 23690322 DERIVED

• Rabago D, Zgierska A, Fortney L, Kijowski R, Mundt M, Ryan M, Grettie J, Patterson JJ. Hypertonic dextrose injections (prolotherapy) for knee osteoarthritis: results of a single-arm uncontrolled study with 1-year follow-up. J Altern Complement Med. 2012 Apr;18(4):408-14. doi: 10.1089/acm.2011.0030.

  PMID: 22515800 DERIVED

Related Links

• University of Wisconsin Department of Family Medicine Web Site

MeSH Terms

Conditions

Osteoarthritis

Interventions

Glucose; Sodium Chloride; Exercise

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• David P. Rabago, MD

  University of Wisconsin Dept of Family Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2004
• First Posted: June 16, 2004
• Study Start: July 1, 2004
• Primary Completion: November 1, 2008
• Study Completion: May 1, 2016
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

US (2)