Tidal Lavage in Knee Osteoarthritis

NCT00000424 | Completed Phase 2

• 2 other identifiers: R01AR042165NIAMS-001
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This study compared the effects of tidal lavage (washing out) of the knee joint and an imitation lavage procedure in people with knee osteoarthritis. In tidal lavage, the doctor flushes out a knee joint with repeated injections of a mild salt solution, done under local anesthesia. Study participants had to meet standard criteria for diagnosis of osteoarthritis but could have low, medium, or high severity of x-ray changes indicating knee osteoarthritis. We performed the lavage procedure once, and did quarterly followups for 1 year. We permitted patients to use some other osteoarthritis treatments during the study, such as non-narcotic pain relievers, nonsteroidal anti-inflammatory drugs, and physical therapy.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis (OA); Knee; Sham lavage; Tidal lavage; Lavage therapy; Nonsteroidal anti-inflammatory drug (NSAID); Placebo; Radiography; Human therapy evaluation; WOMAC

Interventions

Tidal lavage vs. sham lavage of the knee PROCEDURE

Eligibility Criteria

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

You may qualify if:

• Knee pain attributed to osteoarthritis for at least 1 year.
• Meet American College of Rheumatology clinical or clinical plus x-ray criteria for knee osteoarthritis
• Have at least a moderate pain rating on at least one of the five Western Ontario-McMaster University Osteoarthritis Index (WOMAC) scales

You may not qualify if:

• Significant conditions of the spine, hips, or feet that affect the ability to walk
• Significant medical conditions that affect the ability to walk and function
• Inflammatory arthritis, such as rheumatoid arthritis or gout
• Degenerative arthritis secondary to other conditions, such as hemochromatosis, Wilson's disease, or ochronosis
• Current significant soft tissue rheumatism such as fibromyalgia, anserine bursitis, or trochanteric bursitis

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): lead

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Related Publications (4)

• Bradley JD, Heilman DK, Wallick JE, Olin P. Effect of blinding on response to tidal lavage (TL) and sham lavage (SL) in knee osteoarthritis (KOA). Arthritis Rheum 42(Supplement):S292,1999.

  BACKGROUND

• Bradley JD, Heilman DK, G'Sell P: Do psychological factors "predict" response to tidal lavage (TL) and sham lavage (SL) in knee osteoarthritis (KOA)? Arthritis Rheum 43(Supplement):S337,2000

  BACKGROUND

• Bradley JD. Joint irrigation as treatment for osteoarthritis. Curr Rheumatol Rep. 2003 Feb;5(1):20-6. doi: 10.1007/s11926-003-0079-4.

  PMID: 12590881 BACKGROUND

• Bradley JD, Heilman DK, Katz BP, Gsell P, Wallick JE, Brandt KD. Tidal irrigation as treatment for knee osteoarthritis: a sham-controlled, randomized, double-blinded evaluation. Arthritis Rheum. 2002 Jan;46(1):100-8. doi: 10.1002/1529-0131(200201)46:13.0.co;2-v.

  PMID: 11817581 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• John D. Bradley, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: July 1, 1995
• Study Completion: June 1, 2001
• Last Updated: January 1, 2007

Record last verified: 2001-03

Locations

US (1)