Acupuncture for Treatment of Chronic LBP, RCT, Single Blinded

Chronic Low Back Pain Clinical Trial

Official title:

A Randomized, Single Blind, Controlled Clinical Trial to Evaluate the Pain Relief Efficacy, Functional Improvement and Safety of Acupuncture in Patients With Chronic Low Back Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00353847
• Other study ID #: KYD-06
• Status: Active, not recruiting
• Phase: Phase 3
• First received: July 18, 2006
• Last updated: November 15, 2006
• Start date: July 2006

Study information

• Verified date: June 2006
• Source: Korea Institute of Oriental Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether acupuncture is effective and safe in the treatment of chronic LBP.

Description:

The purpose of this study is as follows:

1. pain : VAS

2. Function : Roland Disability Scale

3. Side effect

4. Validity

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Having chronic, non-specific, LBP of at least 3 months’ duration over 20 years old.

• Back pain must be the chief complaint

• Having normal neurological test

• Having signature voluntarily an IRB-approved consent form at enrollment

Exclusion Criteria:

• Potential spinal disease (e.g. a spinal tumor, infection or fracture etc)

• Other diseases (e.g. bleeding disease, dementia,epilepsy, neurogenic disorder etc)

• Planned or got lumbar surgery

• The prior use of acupuncture within the past 6 months

• Inflammatory arthritis

• The current use of systematic corticosteroids, narcotics, anticoagulants, muscle relaxants

• The involvement in legal problem related to LBP

• Refusal to be randomized

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• Acupuncture

Locations

Country	Name	City	State
Korea, Republic of	Wonkwang University Hospital	Gwangju

Sponsors (1)

Lead Sponsor	Collaborator
Korea Institute of Oriental Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale, RDQ scale
Secondary	Patient Global Assessment