Clinical trial NCT00487370: Implantation of Gold Beads to Relieve Discomfort From Knee Osteoarthritis
Official title: Extraarticular Gold Implantation for Treatment of Knee Osteoarthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Acupuncture
Gold implantation
Osteoarthritis
Knee osteoarthritis
Double-blind, randomized controlled trial
Intervention
Family practice
Lead sponsor: Research Unit Of General Practice, Copenhagen
Sponsor class: OTHER
First posted: 2007-06-18
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain from the knee osteoarthritis is evaluated by the patient with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
timeFrame: 0, 1, 3, 6, 9, and 12 months
measure: Stiffness is evaluated with the WOMAC questionnaire.
timeFrame: 0, 1, 3, 6, 9, and 12 months
measure: Function is evaluated with the WOMAC questionnaire.
timeFrame: 0, 1, 3, 6, 9, and 12 months
measure: The same orthopaedic surgeon assesses the patients knee score using the Knee Society Clinical Rating System.
timeFrame: 0, 6, and 12 months
measure: The same orthopaedic surgeon assesses the patients function score using the Knee Society Clinical Rating System.
timeFrame: 0, 6, and 12 months
Secondary outcomes:
measure: The effect of the initial screening by conventional acupuncture - in relation to the five primary outcome measures.
timeFrame: 2 months before randomisation
measure: Side-effects and discomfort from the implantation, primarily whether the implanted gold beads will migrate during the study period.
timeFrame: The entire study period
measure: The time from implantation until the effect possibly sets in.
timeFrame: The entire study period
Other outcomes:
Locations:
city: Holte
country: Denmark
facility: General practice
Study officials:
affiliation: General practice, Dronninggårds Alle 2 B, DK-2840 Holte, Denmark
name: Kirsten Nejrup, MD
role: PRINCIPAL_INVESTIGATOR
References: