Acupuncture in Osteoarthritis of the Knee | NCT00325663

Studies
Acupuncture in Osteoarthritis of the Knee

NCT00325663

Sponsor

Heidelberg University

Status

Completed

Last Update Posted

May 15, 2006Estimated

Enrollment

125

Phase

Phase 1Phase 2

Conditions

Osteoarthritis of the Knee

Interventions

Acupuncture

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2004

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2004

Primary Completion Date

Not provided

Completion Date

Apr 2005

First Submitted Date

May 12, 2006

First Submission Date that Met QC Criteria

May 12, 2006

First Posted Date

May 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2006

Last Update Posted Date

May 15, 2006Estimated

Name	Class
The German Society for Traditional Chinese Medicine (DGTCM)	OTHER

Description Module

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

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

125

Name	Type	Description	Arm Group Labels	Other Names
Acupuncture	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee
D010003	Osteoarthritis
D010146	Pain

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015670	Acupuncture Therapy

Ancestor Terms

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided