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Implantation of Gold Beads to Relieve Discomfort From Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Implantation of gold beads around a knee through needles
Sham implantation: Insertion of needles around a knee
Sponsored by
Research Unit Of General Practice, Copenhagen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Acupuncture, Gold implantation, Osteoarthritis, Knee osteoarthritis, Double-blind, randomized controlled trial, Intervention, Family practice

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • General practice

Outcomes

Primary Outcome Measures

Pain from the knee osteoarthritis is evaluated by the patient with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Stiffness is evaluated with the WOMAC questionnaire.
Function is evaluated with the WOMAC questionnaire.
The same orthopaedic surgeon assesses the patients knee score using the Knee Society Clinical Rating System.
The same orthopaedic surgeon assesses the patients function score using the Knee Society Clinical Rating System.

Secondary Outcome Measures

The effect of the initial screening by conventional acupuncture - in relation to the five primary outcome measures.
Side-effects and discomfort from the implantation, primarily whether the implanted gold beads will migrate during the study period.
The time from implantation until the effect possibly sets in.

Full Information

First Posted
June 15, 2007
Last Updated
June 15, 2007
Sponsor
Research Unit Of General Practice, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT00487370
Brief Title
Implantation of Gold Beads to Relieve Discomfort From Knee Osteoarthritis
Official Title
Extraarticular Gold Implantation for Treatment of Knee Osteoarthritis.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
March 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 1998 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Research Unit Of General Practice, Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Acupuncture, Gold implantation, Osteoarthritis, Knee osteoarthritis, Double-blind, randomized controlled trial, Intervention, Family practice

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Implantation of gold beads around a knee through needles
Intervention Type
Procedure
Intervention Name(s)
Sham implantation: Insertion of needles around a knee
Primary Outcome Measure Information:
Title
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
Title
Stiffness is evaluated with the WOMAC questionnaire.
Time Frame
0, 1, 3, 6, 9, and 12 months
Title
Function is evaluated with the WOMAC questionnaire.
Time Frame
0, 1, 3, 6, 9, and 12 months
Title
The same orthopaedic surgeon assesses the patients knee score using the Knee Society Clinical Rating System.
Time Frame
0, 6, and 12 months
Title
The same orthopaedic surgeon assesses the patients function score using the Knee Society Clinical Rating System.
Time Frame
0, 6, and 12 months
Secondary Outcome Measure Information:
Title
The effect of the initial screening by conventional acupuncture - in relation to the five primary outcome measures.
Time Frame
2 months before randomisation
Title
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
Title
The time from implantation until the effect possibly sets in.
Time Frame
The entire study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten Nejrup, MD
Organizational Affiliation
General practice, Dronninggårds Alle 2 B, DK-2840 Holte, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
General practice
City
Holte
ZIP/Postal Code
DK-2840
Country
Denmark

12. IPD Sharing Statement

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Implantation of Gold Beads to Relieve Discomfort From Knee Osteoarthritis

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