Implantation of Gold Beads to Relieve Discomfort From Knee Osteoarthritis

Research Unit Of General Practice, Copenhagen43 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Osteoarthritis, Knee

Interventions

Implantation of gold beads around a knee through needlesPROCEDURE

Sham implantation: Insertion of needles around a kneePROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

General practice

Holte, Denmark

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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