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Efficacy of Different Acupuncture Methods for Chronic Low Back Pain

Primary Purpose

Chronic Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Acupuncture 1

Acupuncture 2

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring low back pain, acupuncture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

ambulatory practice Yang-Strobel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acupuncture 1

Acupuncture 2

Arm Description

Outcomes

Primary Outcome Measures

Pain intensity over 8 weeks (area under the curve)

Secondary Outcome Measures

Intensity of back pain at week 8 and week 26

Back function (FFbH-R)

QoL

Days with medication intake

Days with physical therapy because of back pain

Sick leave days

Number of therapy sessions

Duration of therapy

Adverse effects and severe adverse effects

Full Information

NCT ID

NCT00758017

First Posted

September 22, 2008

Last Updated

June 21, 2011

Sponsor

Charite University, Berlin, Germany

1. Study Identification

Unique Protocol Identification Number

NCT00758017

Brief Title

Efficacy of Different Acupuncture Methods for Chronic Low Back Pain

Official Title

Efficacy of Different Acupuncture Methods for Chronic Low Back Pain

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Low Back Pain

Keywords

low back pain, acupuncture

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture 1

Arm Type

Experimental

Arm Title

Acupuncture 2

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Acupuncture 1

Intervention Description

Application of individualised acupuncture

Intervention Type

Other

Intervention Name(s)

Acupuncture 2

Intervention Description

Application of standardised acupuncture

Primary Outcome Measure Information:

Title

Pain intensity over 8 weeks (area under the curve)

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Intensity of back pain at week 8 and week 26

Time Frame

baseline, week 8, week 26

Title

Back function (FFbH-R)

Time Frame

baseline, week 8, week 26

Title

QoL

Time Frame

baseline, week 8, week 26

Title

Days with medication intake

Time Frame

baseline to end of week 8

Title

Days with physical therapy because of back pain

Time Frame

baseline to end of week 8

Title

Sick leave days

Time Frame

baseline, at week 8, at week 26

Title

Number of therapy sessions

Time Frame

baseline to expected time frame 3 months

Title

Duration of therapy

Time Frame

baseline to expected time frame 3 months

Title

Adverse effects and severe adverse effects

Time Frame

baseline to expected time frame 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Claudia M. Witt, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

ambulatory practice Yang-Strobel

City

Berlin

ZIP/Postal Code

13581

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

24288556

Citation

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.

Results Reference

derived

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Efficacy of Different Acupuncture Methods for Chronic Low Back Pain

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