Efficacy of Different Acupuncture Methods for Chronic Low Back Pain

Chronic Low Back Pain Clinical Trial

Official title:

Efficacy of Different Acupuncture Methods for Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00758017
• Other study ID #: Aku-08
• Status: Completed
• Phase: N/A
• First received: September 22, 2008
• Last updated: June 21, 2011
• Start date: January 2009
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• Acupuncture 1
Application of individualised acupuncture
• Acupuncture 2
Application of standardised acupuncture

Locations

Country	Name	City	State
Germany	ambulatory practice Yang-Strobel	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity over 8 weeks (area under the curve)		8 weeks	No
Secondary	Intensity of back pain at week 8 and week 26		baseline, week 8, week 26	No
Secondary	Back function (FFbH-R)		baseline, week 8, week 26	No
Secondary	QoL		baseline, week 8, week 26	No
Secondary	Days with medication intake		baseline to end of week 8	No
Secondary	Days with physical therapy because of back pain		baseline to end of week 8	No
Secondary	Sick leave days		baseline, at week 8, at week 26	No
Secondary	Number of therapy sessions		baseline to expected time frame 3 months	No
Secondary	Duration of therapy		baseline to expected time frame 3 months	No
Secondary	Adverse effects and severe adverse effects		baseline to expected time frame 3 months	Yes