NCT00353847

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

July 1, 2006

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2006

Completed
Last Updated

November 16, 2006

Status Verified

June 1, 2006

First QC Date

July 18, 2006

Last Update Submit

November 15, 2006

Conditions

Chronic Low Back Pain

Keywords

acupuncture, RCTs, chronic LBP

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale, RDQ scale

Secondary Outcomes (1)

  • Patient Global Assessment

Interventions

AcupunctureDEVICE

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wonkwang University Hospital

Gwangju, Gwangju, 503-310, South Korea

Location

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Youngdal Kwon, MD, Ph.D

    Professor of College of Oriental Medicine, Wonkwang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 18, 2006

First Posted

July 19, 2006

Study Start

July 1, 2006

Last Updated

November 16, 2006

Record last verified: 2006-06

Locations

KR(1)