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
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
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
NCT ID
NCT00487370
First Posted
June 15, 2007
Last Updated
June 15, 2007
Sponsor
Research Unit Of General Practice, Copenhagen
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
Learn more about this trial
Implantation of Gold Beads to Relieve Discomfort From Knee Osteoarthritis
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