Implantation of Gold Beads to Relieve Discomfort From Knee Osteoarthritis

June 15, 2007 updated by: Research Unit Of General Practice, Copenhagen

Extraarticular Gold Implantation for Treatment of Knee Osteoarthritis.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Holte, Denmark, DK-2840
        • General Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
0, 6, and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The effect of the initial screening by conventional acupuncture - in relation to the five primary outcome measures.
Time Frame: 2 months before randomisation
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 entire study period
The time from implantation until the effect possibly sets in.
Time Frame: The entire study period
The entire study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Unit Of General Practice, Copenhagen

Investigators

  • Principal Investigator: Kirsten Nejrup, MD, General practice, Dronninggårds Alle 2 B, DK-2840 Holte, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1997

Study Completion (Actual)

December 1, 1998

Study Registration Dates

First Submitted

June 15, 2007

First Submitted That Met QC Criteria

June 15, 2007

First Posted (Estimate)

June 18, 2007

Study Record Updates

Last Update Posted (Estimate)

June 18, 2007

Last Update Submitted That Met QC Criteria

June 15, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KN1996

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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