Efficacy of Different Acupuncture Methods for Chronic Low... | NCT00758017

Studies
Efficacy of Different Acupuncture Methods for Chronic Low Back Pain

NCT00758017

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Jun 22, 2011Estimated

Enrollment

150Actual

Phase

Not Applicable

Conditions

Chronic Low Back Pain

Interventions

Acupuncture 1
Acupuncture 2

Countries

Germany

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

Jun 2011

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

Jan 2009

Primary Completion Date

Mar 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Sep 22, 2008

First Submission Date that Met QC Criteria

Sep 22, 2008

First Posted Date

Sep 23, 2008Estimated

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

Jun 21, 2011

Last Update Posted Date

Jun 22, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acupuncture 1	Experimental		Other: Acupuncture 1
Acupuncture 2	Active Comparator		Other: Acupuncture 2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acupuncture 1	Other	Application of individualised acupuncture	Acupuncture 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain intensity over 8 weeks (area under the curve)		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Intensity of back pain at week 8 and week 26		baseline, week 8, week 26
Back function (FFbH-R)		baseline, week 8, week 26
QoL

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claudia M. Witt, MD	Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ambulatory practice Yang-Strobel		Berlin		13581	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24288556	Derived	Pach D, Yang-Strobel X, Ludtke R, Roll S, Icke K, Brinkhaus B, Witt CM. Standardized versus Individualized Acupuncture for Chronic Low Back Pain: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2013;2013:125937. doi: 10.1155/2013/125937. Epub 2013 Oct 28.

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms