Acupuncture for Treatment of Chronic LBP, RCT, Single Bli... | NCT00353847

Studies
Acupuncture for Treatment of Chronic LBP, RCT, Single Blinded

NCT00353847

Sponsor

Korea Institute of Oriental Medicine

Status

Unknown status

Last Update Posted

Nov 16, 2006Estimated

Enrollment

Phase

Phase 3

Conditions

Chronic Low Back Pain

Interventions

Acupuncture

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 18, 2006

First Submission Date that Met QC Criteria

Jul 18, 2006

First Posted Date

Jul 19, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2006

Last Update Posted Date

Nov 16, 2006Estimated

Description Module

Brief Summary

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

Detailed Description

The purpose of this study is as follows:

pain : VAS
Function : Roland Disability Scale
Side effect
Validity

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Acupuncture	Device

Measure	Description	Time Frame
Visual Analogue Scale, RDQ scale

Measure	Description	Time Frame
Patient Global Assessment

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Youngdal Kwon, MD, Ph.D	Professor of College of Oriental Medicine, Wonkwang University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wonkwang University Hospital		Gwangju	Gwangju	503-310	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D015670	Acupuncture Therapy

Ancestor Terms

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided