Implantation of Gold Beads to Relieve Discomfort From Knee Osteoarthritis
The purpose of this study is to determine whether implanting gold beads extraarticularly in five acupuncture-points around a knee improves pain, stiffness and function in patients with knee osteoarthritis.
Procedure: Implantation of gold beads around a knee through needles
Procedure: Sham implantation: Insertion of needles around a knee
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Extraarticular Gold Implantation for Treatment of Knee Osteoarthritis.|
- Pain from the knee osteoarthritis is evaluated by the patient with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). [ Time Frame: 0, 1, 3, 6, 9, and 12 months ]
- Stiffness is evaluated with the WOMAC questionnaire. [ Time Frame: 0, 1, 3, 6, 9, and 12 months ]
- Function is evaluated with the WOMAC questionnaire. [ Time Frame: 0, 1, 3, 6, 9, and 12 months ]
- The same orthopaedic surgeon assesses the patients knee score using the Knee Society Clinical Rating System. [ Time Frame: 0, 6, and 12 months ]
- The same orthopaedic surgeon assesses the patients function score using the Knee Society Clinical Rating System. [ Time Frame: 0, 6, and 12 months ]
- The effect of the initial screening by conventional acupuncture - in relation to the five primary outcome measures. [ Time Frame: 2 months before randomisation ]
- Side-effects and discomfort from the implantation, primarily whether the implanted gold beads will migrate during the study period. [ Time Frame: The entire study period ]
- The time from implantation until the effect possibly sets in. [ Time Frame: The entire study period ]
|Study Start Date:||March 1997|
|Study Completion Date:||December 1998|
Osteoarthritis (OA) is one of the most common diagnoses made in general practice and among the most common causes of disability in older people. Acupuncture is a well-founded supplement or alternative to pharmacological and surgical treatment methods. The improvement is, however, often brief, so to preserve the initial effect the acupuncture has to be repeated at regular intervals.
In veterinarian medicine implantation of gold-beads in acupuncture-points around a joint has been used mostly in dogs for at least 30 years in the treatment of OA. The effect measured on eating pattern, physical activity and signs of pain last for several years. It may be hypothesized that implanting gold in acupuncture points acts as a continuous acupuncture stimulation.
The purpose of this one year randomised, controlled trial of middle-aged and elderly patients is to examine the effect of implanting gold beads extraarticularly in five acupuncture-points around a knee with OA.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00487370
|Holte, Denmark, DK-2840|
|Principal Investigator:||Kirsten Nejrup, MD||General practice, Dronninggårds Alle 2 B, DK-2840 Holte, Denmark|