Trials
Search / Trial NCT00000424

Tidal Lavage in Knee Osteoarthritis

Launched by NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES (NIAMS) · Nov 3, 1999

Trial Information

Current as of January 15, 2025

Completed

Keywords

Osteoarthritis (Oa) Knee Sham Lavage Tidal Lavage Lavage Therapy Nonsteroidal Anti Inflammatory Drug (Nsaid) Placebo Radiography Human Therapy Evaluation Womac

ClinConnect Summary

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 ...

Gender

ALL

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

Trial Officials

John D. Bradley, MD

Principal Investigator

Indiana University School of Medicine

About National Institute Of Arthritis And Musculoskeletal And Skin Diseases (Niams)

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is a pivotal component of the National Institutes of Health (NIH) dedicated to advancing research and knowledge in the fields of arthritis, musculoskeletal disorders, and skin diseases. NIAMS sponsors a wide range of clinical trials aimed at improving the diagnosis, treatment, and prevention of these conditions. By fostering innovative research, collaborating with healthcare professionals, and engaging with patient communities, NIAMS strives to enhance the quality of life for individuals affected by these diseases, while promoting scientific discovery and public health initiatives.

Locations

Indianapolis, Indiana, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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