Implantation of Gold Beads to Relieve Discomfort From Knee Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-03-31

Study Completion Date

1998-12-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Implantation of gold beads around a knee through needles

Intervention Type PROCEDURE

Sham implantation: Insertion of needles around a knee

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Kirsten Nejrup, MD

Role: PRINCIPAL_INVESTIGATOR

General practice, Dronninggårds Alle 2 B, DK-2840 Holte, Denmark

Locations

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General practice

Holte, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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KN1996

Identifier Type: -

Identifier Source: org_study_id