Implantation of Gold Beads to Relieve Discomfort From Knee Osteoarthritis

Research Unit Of General Practice, Copenhagen

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Procedure: Sham implantation: Insertion of needles around a knee; Procedure: Implantation of gold beads around a knee through needles

Study type: Interventional

Funder types: Other

Identifiers

NCT00487370

KN1996

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind