NCT00325663

Brief Summary

The aim of this study was to evalute three different acupuncture techniques, including one sham control, in its effect on osteoarthitis of the knee

Trial Health

100
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2004

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

April 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2006

Completed
Last Updated

May 15, 2006

Status Verified

April 1, 2004

First QC Date

May 12, 2006

Last Update Submit

May 12, 2006

Conditions

Osteoarthritis of the Knee

Keywords

acupuncturedouble-blindsham controlosteoarthritispain

Outcome Measures

Primary Outcomes (1)

  • Main outcome measures: Improvement in knee flexibility according to the neutral-zero method, defining a success as improvement by 10 degrees or more.

Secondary Outcomes (1)

  • Secondary parameter: improvement in pain according to the reduced WOMAC score by 50 percent or more.

Interventions

AcupuncturePROCEDURE

Eligibility Criteria

Age35 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients above age 35
  • knee osteoarthritis grade II or III according to the Kellgren classification.

You may not qualify if:

  • orthopedic deformations of the knee,
  • malignant disease
  • auto-immune disorders
  • surgery including arthroscopy during the past 12 months
  • pain medication with steroids
  • physical therapy or acupuncture within the last for weeks
  • no or a pain medication in continuous dosage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisPain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Max Karner, MD

    University Heidelberg

    PRINCIPAL INVESTIGATOR

  • Johannes Greten, MD

    German Society of Traditional Chinese Medicine

    STUDY DIRECTOR

  • Oliver Gerlach, MD

    Shen-Centre for Traditional Chinese Medicine, Erlangen, Germany

    STUDY CHAIR

  • Frank Brazkiewicz, MD

    Centre for Chinese Medicine, Bremen, Germany

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2006

First Posted

May 15, 2006

Study Start

April 1, 2004

Study Completion

April 1, 2005

Last Updated

May 15, 2006

Record last verified: 2004-04