Implantation of Gold Beads to Relieve Discomfort From Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

Extraarticular Gold Implantation for Treatment of Knee Osteoarthritis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00487370
• Other study ID #: KN1996
• Status: Completed
• Phase: N/A
• First received: June 15, 2007
• Last updated: June 15, 2007
• Start date: March 1997
• Est. completion date: December 1998

Study information

• Verified date: June 2007
• Source: Research Unit Of General Practice, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Implantation of gold beads around a knee through needles

• Sham implantation: Insertion of needles around a knee

Locations

Country	Name	City	State
Denmark	General practice	Holte

Sponsors (1)

Lead Sponsor	Collaborator
Research Unit Of General Practice, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Stiffness is evaluated with the WOMAC questionnaire.		0, 1, 3, 6, 9, and 12 months
Primary	Function is evaluated with the WOMAC questionnaire.		0, 1, 3, 6, 9, and 12 months
Primary	The same orthopaedic surgeon assesses the patients knee score using the Knee Society Clinical Rating System.		0, 6, and 12 months
Primary	The same orthopaedic surgeon assesses the patients function score using the Knee Society Clinical Rating System.		0, 6, and 12 months
Secondary	The effect of the initial screening by conventional acupuncture - in relation to the five primary outcome measures.		2 months before randomisation
Secondary	Side-effects and discomfort from the implantation, primarily whether the implanted gold beads will migrate during the study period.		The entire study period
Secondary	The time from implantation until the effect possibly sets in.		The entire study period