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Implantation of Gold Beads to Relieve Discomfort From Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by:
Research Unit Of General Practice, Copenhagen
ClinicalTrials.gov Identifier:
NCT00487370
First received: June 15, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Osteoarthritis, Knee
Procedure: Implantation of gold beads around a knee through needles
Procedure: Sham implantation: Insertion of needles around a knee

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Extraarticular Gold Implantation for Treatment of Knee Osteoarthritis.

Resource links provided by NLM:


Further study details as provided by Research Unit Of General Practice, Copenhagen:

Primary Outcome Measures:
  • 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 ]
  • Stiffness is evaluated with the WOMAC questionnaire. [ Time Frame: 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 ]
  • The same orthopaedic surgeon assesses the patients knee score using the Knee Society Clinical Rating System. [ Time Frame: 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 ]

Secondary Outcome Measures:
  • The effect of the initial screening by conventional acupuncture - in relation to the five primary outcome measures. [ Time Frame: 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 time from implantation until the effect possibly sets in. [ Time Frame: The entire study period ]

Enrollment: 43
Study Start Date: March 1997
Study Completion Date: December 1998
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487370

Locations
Denmark
General practice
Holte, Denmark, DK-2840
Sponsors and Collaborators
Research Unit Of General Practice, Copenhagen
Investigators
Principal Investigator: Kirsten Nejrup, MD General practice, Dronninggårds Alle 2 B, DK-2840 Holte, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00487370     History of Changes
Other Study ID Numbers: KN1996
Study First Received: June 15, 2007
Last Updated: June 15, 2007
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Research Unit Of General Practice, Copenhagen:
Acupuncture
Gold implantation
Osteoarthritis
Knee osteoarthritis
Double-blind, randomized controlled trial
Intervention
Family practice

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 27, 2014