search
Back to results

Tidal Lavage in Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tidal lavage vs. sham lavage of the knee
Sponsored by
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis (OA), Knee, Sham lavage, Tidal lavage, Lavage therapy, Nonsteroidal anti-inflammatory drug (NSAID), Placebo, Radiography, Human therapy evaluation, WOMAC

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Indiana University School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
December 28, 2006
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
search

1. Study Identification

Unique Protocol Identification Number
NCT00000424
Brief Title
Tidal Lavage in Knee Osteoarthritis
Official Title
Tidal Lavage vs. Sham Lavage in Knee Osteoarthritis (OA)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2001
Overall Recruitment Status
Completed
Study Start Date
July 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

5. Study Description

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.
Detailed Description
This study was a randomized, double-blind, sham procedure-controlled evaluation of tidal lavage as a treatment for knee osteoarthritis. We achieved blinding by raising a drape during the study procedure and mimicking the sensory aspects of tidal lavage, but not flushing the knee, in the sham lavage group. We gave all study participants subcutaneous anesthesia with lidocaine and then bupivacaine and then attempted aspiration of the knee, removing up to 5 ml of synovial fluid for examination and then injecting the knee with 20 ml of bupivicaine. In people who received the sham treatment, we placed a 16-gauge catheter in the lateral suprapatellar position just to the knee joint capsule and infused small volumes (less than 5 ml per "exchange" x 20) of saline into the subcutaneous tissue while manipulating the anterior knee to mimic efforts to shift fluid within the knee during the "aspiration" phase of each exchange. Patients could see the supply bag of sterile saline but could not see the waste bag of this closed drainage system. For tidal lavage patients, we made the catheter puncture in the lateral suprapatellar pouch and repeatedly distended the knee with 30-50 ml of sterile saline, then aspirated this volume (about 20 exchanges for a total of 1 liter of flush solution). At the end of the procedure, we told the patients that their knee might be swollen due to retained saline, and to expect this additional swelling to resolve over 24-48 hours, during which time they were to minimize activity. The person who did the procedure (the principal investigator) then left the room. The study nurse, who was not present for the procedure and was blinded to the procedure's identity, asked the patients which treatment they thought they received (tidal lavage or sham lavage). We scheduled patient followups with this study nurse for 3, 6, and 12 months, and patients completed questionnaires at each visit. Questionnaires were both arthritis-specific (WOMAC) and global (Quality of Well-Being).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis (OA), Knee, Sham lavage, Tidal lavage, Lavage therapy, Nonsteroidal anti-inflammatory drug (NSAID), Placebo, Radiography, Human therapy evaluation, WOMAC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
180 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Tidal lavage vs. sham lavage of the knee

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D. Bradley, MD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
12590881
Citation
Bradley JD. Joint irrigation as treatment for osteoarthritis. Curr Rheumatol Rep. 2003 Feb;5(1):20-6. doi: 10.1007/s11926-003-0079-4.
Results Reference
background
PubMed Identifier
11817581
Citation
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.
Results Reference
result

Learn more about this trial

Tidal Lavage in Knee Osteoarthritis

We'll reach out to this number within 24 hrs