Search / Trial NCT00000424

Tidal Lavage in Knee Osteoarthritis

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

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Trial Information

Current as of December 10, 2023

Completed

Keywords

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

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 ...

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

Attachments

readout_NCT00000424_2023-12-10.pdf

4.5 MB

NCT00000424_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Indianapolis, Indiana, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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