Implantation of Gold Beads to Relieve Discomfort From Knee Osteoarthritis

Sponsor

Research Unit Of General Practice, Copenhagen (Other)

Overall Status

Completed

CT.gov ID

NCT00487370

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Procedure: Implantation of gold beads around a knee through needles Procedure: Sham implantation: Insertion of needles around a knee	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Extraarticular Gold Implantation for Treatment of Knee Osteoarthritis.

Study Start Date :

Mar 1, 1997

Actual Study Completion Date :

Dec 1, 1998

Outcome Measures

Primary Outcome Measures

Pain from the knee osteoarthritis is evaluated by the patient with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). [0, 1, 3, 6, 9, and 12 months]
Stiffness is evaluated with the WOMAC questionnaire. [0, 1, 3, 6, 9, and 12 months]
Function is evaluated with the WOMAC questionnaire. [0, 1, 3, 6, 9, and 12 months]
The same orthopaedic surgeon assesses the patients knee score using the Knee Society Clinical Rating System. [0, 6, and 12 months]
The same orthopaedic surgeon assesses the patients function score using the Knee Society Clinical Rating System. [0, 6, and 12 months]

Secondary Outcome Measures

The effect of the initial screening by conventional acupuncture - in relation to the five primary outcome measures. [2 months before randomisation]
Side-effects and discomfort from the implantation, primarily whether the implanted gold beads will migrate during the study period. [The entire study period]
The time from implantation until the effect possibly sets in. [The entire study period]