Osteoarthritis, Knee
Conditions
Keywords
Acupuncture, Gold implantation, Osteoarthritis, Knee osteoarthritis, Double-blind, randomized controlled trial, Intervention, Family practice
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.
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.
Interventions
PROCEDUREImplantation of gold beads around a knee through needles
PROCEDURESham implantation: Insertion of needles around a knee
Sponsors
Research Unit Of General Practice, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-80 years * Clinically diagnosed and radiologically verified knee osteoarthritis (OA) * Pain and stiffness derived from OA lasting for more than one year
Exclusion criteria
* Previous knee trauma (OA following previous meniscectomy is included) * Other rheumatologic conditions like rheumatoid arthritis or fibromyalgia * Pronounced hip OA * Severe somatic or mental illnesses * Dementia * Alcohol or drug abuse * Pregnancy * Anticoagulant treatment * Corticosteroid treatment during the last 3 months * Allergy to chlorhexidine or local anaesthetics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Denmark
Outcome results
None listed