NCT00758017

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 22, 2011

Status Verified

June 1, 2011

Enrollment Period

2.2 years

First QC Date

September 22, 2008

Last Update Submit

June 21, 2011

Conditions

Chronic Low Back Pain

Keywords

low back painacupuncture

Outcome Measures

Primary Outcomes (1)

  • Pain intensity over 8 weeks (area under the curve)

    8 weeks

Secondary Outcomes (9)

  • 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

    baseline, week 8, week 26

  • Days with medication intake

    baseline to end of week 8

  • Days with physical therapy because of back pain

    baseline to end of week 8

  • +4 more secondary outcomes

Study Arms (2)

Acupuncture 1

EXPERIMENTAL
Other: Acupuncture 1

Acupuncture 2

ACTIVE COMPARATOR
Other: Acupuncture 2

Interventions

Acupuncture 1OTHER

Application of individualised acupuncture

Acupuncture 1
Acupuncture 2OTHER

Application of standardised acupuncture

Acupuncture 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ambulatory practice Yang-Strobel

Berlin, 13581, Germany

Location

Related Publications (1)

  • 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.

    PMID: 24288556DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Claudia M. Witt, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 22, 2008

First Posted

September 23, 2008

Study Start

January 1, 2009

Primary Completion

March 1, 2011

Study Completion

June 1, 2011

Last Updated

June 22, 2011

Record last verified: 2011-06

Locations

DE(1)