NCT00487370

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 1997

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1997

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1998

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2007

Completed
Last Updated

June 18, 2007

Status Verified

June 1, 2007

First QC Date

June 15, 2007

Last Update Submit

June 15, 2007

Conditions

Osteoarthritis, Knee

Keywords

AcupunctureGold implantationOsteoarthritisKnee osteoarthritisDouble-blind, randomized controlled trialInterventionFamily practice

Outcome Measures

Primary Outcomes (5)

  • Pain from the knee osteoarthritis is evaluated by the patient with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

    0, 1, 3, 6, 9, and 12 months

  • Stiffness is evaluated with the WOMAC questionnaire.

    0, 1, 3, 6, 9, and 12 months

  • Function is evaluated with the WOMAC questionnaire.

    0, 1, 3, 6, 9, and 12 months

  • The same orthopaedic surgeon assesses the patients knee score using the Knee Society Clinical Rating System.

    0, 6, and 12 months

  • The same orthopaedic surgeon assesses the patients function score using the Knee Society Clinical Rating System.

    0, 6, and 12 months

Secondary Outcomes (3)

  • The effect of the initial screening by conventional acupuncture - in relation to the five primary outcome measures.

    2 months before randomisation

  • Side-effects and discomfort from the implantation, primarily whether the implanted gold beads will migrate during the study period.

    The entire study period

  • The time from implantation until the effect possibly sets in.

    The entire study period

Interventions

Implantation of gold beads around a knee through needlesPROCEDURE
Sham implantation: Insertion of needles around a kneePROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-80 years
  • Clinically diagnosed and radiologically verified knee osteoarthritis (OA)
  • Pain and stiffness derived from OA lasting for more than one year

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General practice

Holte, DK-2840, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kirsten Nejrup, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2007

First Posted

June 18, 2007

Study Start

March 1, 1997

Study Completion

December 1, 1998

Last Updated

June 18, 2007

Record last verified: 2007-06

Locations

DK(1)