Efficacy of Different Acupuncture Methods for Chronic Low Back Pain - Full Text View

Sponsored by:	Charite University, Berlin, Germany
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00758017

Purpose

The aim of the study is to evaluate pain intensity over 8 weeks in acupuncture patients with chronic low back pain and to compare 2 different groups of patients which differ in the acupuncture method used to treat the pain.

Condition	Intervention
Chronic Low Back Pain	Other: Acupuncture 1 Other: Acupuncture 2

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Different Acupuncture Methods for Chronic Low Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Acupuncture Back Pain

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:

Pain intensity over 8 weeks (area under the curve) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Intensity of back pain at week 8 and week 26 [ Time Frame: baseline, week 8, week 26 ] [ Designated as safety issue: No ]
Back function (FFbH-R) [ Time Frame: baseline, week 8, week 26 ] [ Designated as safety issue: No ]
QoL [ Time Frame: baseline, week 8, week 26 ] [ Designated as safety issue: No ]
Days with medication intake [ Time Frame: baseline to end of week 8 ] [ Designated as safety issue: No ]
Days with physical therapy because of back pain [ Time Frame: baseline to end of week 8 ] [ Designated as safety issue: No ]
Sick leave days [ Time Frame: baseline, at week 8, at week 26 ] [ Designated as safety issue: No ]
Number of therapy sessions [ Time Frame: baseline to expected time frame 3 months ] [ Designated as safety issue: No ]
Duration of therapy [ Time Frame: baseline to expected time frame 3 months ] [ Designated as safety issue: No ]
Adverse effects and severe adverse effects [ Time Frame: baseline to expected time frame 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	January 2009
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Acupuncture 1: Experimental	Other: Acupuncture 1 Application of individualised acupuncture
Acupuncture 2: Active Comparator	Other: Acupuncture 2 Application of standardised acupuncture

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

diagnosis of chronic low back pain (for at least 3 months) confirmed by a consultant
indication for treatment of low back pain with acupuncture confirmed by a consultant
at least 40 mm on a VAS pain scale

Exclusion Criteria:

acupuncture during the last 6 months
start of a new therapy for low back pain within the last 4 weeks
pregnancy
substance or drug abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758017

Contacts

Contact: Claudia M. Witt, MD

+ 49 - 30 / 450-529132

claudia.witt@charite.de

Locations

Germany
ambulatory practice Yang-Strobel	Recruiting
Berlin, Germany, 13581
Sub-Investigator: Yang-Strobel

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

Principal Investigator:

Claudia M. Witt, MD

Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany

More Information

No publications provided

Responsible Party:	Institute for Social Medicine, Epidemiology, and Health Economics, Charité ( Claudia M. Witt, MD )
Study ID Numbers:	Aku-08
Study First Received:	September 22, 2008
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00758017 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:

low back pain
acupuncture

Study placed in the following topic categories:

Signs and Symptoms
Neurologic Manifestations
Low Back Pain
Pain
Back Pain

Additional relevant MeSH terms:

Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations

Low Back Pain
Pain
Back Pain

ClinicalTrials.gov processed this record on September 11, 2009