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Completed

NCT Number: NCT00325663

Acupuncture in Osteoarthritis of the Knee

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

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

35 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

Background: Acupuncture is one of the most frequently used complementary therapeutic approaches in the treatment of osteoarthritis of the knee. Due to methodological shortcomings of previous randomized controlled studies, controversy persists whether the observed effects are specific to acupuncture or non-specific consequences of needling.

Objective: To compare classical Chinese acupuncture, semi-standardized modern acupuncture and non-specific needling by means of a double-blinded repeated measures cross-over design.

Intervention: Within three weeks all patients receive three treatment modalities in a random order in a double-blind study design.

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Acupuncture

Procedure

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.

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Collaborators

  • The German Society for Traditional Chinese Medicine (DGTCM)

Registry information

Official study title

Specific and Non-Specific Effects of Acupuncture: A Double-Blinded, Randomized, Controlled Trial in Patients With Osteoarthritis of the Knee

Important dates

Study start
2004
Study completion
2005
First posted
May 15, 2006
Registry last updated
May 15, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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