Implantation of Gold Beads to Relieve Discomfort From Knee Osteoarthritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Extraarticular Gold Implantation for Treatment of Knee Osteoarthritis.

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Procedure: Implantation of gold beads around a knee through needles
* Procedure: Sham implantation: Insertion of needles around a knee


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Implantation of gold beads around a knee through needles|nan|
|Procedure: Sham implantation: Insertion of needles around a knee|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Gold implantation, Osteoarthritis, Knee osteoarthritis, Double-blind, randomized controlled trial, Intervention, Family practice