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A Random Controlled Test (RCT): Acupuncture Treatment on Nonspecific Low Back Pain (NLBP) (ANLBP)

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Acupuncture Treatment
Sham acupuncture
Sponsored by
Beijing Hospital of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain, Acupuncture, RCT

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient who is suffering the Non-specific Low Back Pain which meets the diagnostic criterion of posterior ramus of lumbar spinal nerve syndrome.
  • The patient who is from 18 to 79 years old.
  • The patient who can comprehensively understand and fill in the questionnaires about the disease.
  • The patient who suffered problems no less than 12 weeks.
  • The patient who have not the other diseases which can result in back pain.
  • The patient who received the clear examinations of X-ray, CT scan or MRI.
  • The patient who wrote the informed consents.

Exclusion Criteria:

  • The patient whose low back pain is the consequences of spondyloschisis, Spondylolysis, osteoarthritis, osteoporosis, internal disease, metastatic tumor.
  • The patient who have the hemorrhagic disease such as hemophilia.
  • The patient who have the spinal diseases which have not been diagnosed clearly.

Sites / Locations

  • Beijing TCM HospitalRecruiting
  • Hospital CF Iasi, Clinic of Rehabilitation Medicine, Phys. Med., Balneoclimatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Verus acupuncture

Sham acupuncture

Arm Description

Outcomes

Primary Outcome Measures

Score of SF-36

Secondary Outcome Measures

Oswestry Disability Index (ODI)

Full Information

First Posted
January 13, 2010
Last Updated
March 18, 2010
Sponsor
Beijing Hospital of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01049074
Brief Title
A Random Controlled Test (RCT): Acupuncture Treatment on Nonspecific Low Back Pain (NLBP)
Acronym
ANLBP
Official Title
A Random Controlled Test (RCT): Acupuncture Treatment on Nonspecific Low Back Pain (NLBP) (ANLBP)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2010 (Anticipated)
Study Completion Date
November 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Beijing Hospital of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Hypothesis: Acupuncture procedure of He's Santong Methods could be an option to treat nonspecific low back pain.
Detailed Description
He's Santong Methods is a combined manipulated needling methods, including filiform needling, fire needling and bloodletting needling, which was created by Dr. He Puren who is one of the most famous TCM doctors in China.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low Back Pain, Acupuncture, RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
534 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Verus acupuncture
Arm Type
Experimental
Arm Title
Sham acupuncture
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Acupuncture Treatment
Intervention Description
Acupuncture is a technique of inserting and manipulating fine needles into specific points on the body to relieve pain or for therapeutic purposes.
Intervention Type
Other
Intervention Name(s)
Sham acupuncture
Intervention Description
Sham acupuncture is inserting needles superficially, without manipulating, into specific points on the body.
Primary Outcome Measure Information:
Title
Score of SF-36
Time Frame
4 weeks, 8 weeks, 12 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Oswestry Disability Index (ODI)
Time Frame
4 weeks, 8 weeks, 12 weeks, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient who is suffering the Non-specific Low Back Pain which meets the diagnostic criterion of posterior ramus of lumbar spinal nerve syndrome. The patient who is from 18 to 79 years old. The patient who can comprehensively understand and fill in the questionnaires about the disease. The patient who suffered problems no less than 12 weeks. The patient who have not the other diseases which can result in back pain. The patient who received the clear examinations of X-ray, CT scan or MRI. The patient who wrote the informed consents. Exclusion Criteria: The patient whose low back pain is the consequences of spondyloschisis, Spondylolysis, osteoarthritis, osteoporosis, internal disease, metastatic tumor. The patient who have the hemorrhagic disease such as hemophilia. The patient who have the spinal diseases which have not been diagnosed clearly.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peng Chen, M.D.
Phone
86-10-52176636
Email
chenpenger@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linpeng Wang, M.D.
Organizational Affiliation
Beijing TCM Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stratulat Ioan Sorin, M.D.
Organizational Affiliation
Hospital CF Iasi, Clinic of Rehabilitation Medicine, Phys. Med., Balneoclimatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing TCM Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Chen, M.D.
Phone
86-10-52176636
Email
chenpenger@yahoo.com.cn
Facility Name
Hospital CF Iasi, Clinic of Rehabilitation Medicine, Phys. Med., Balneoclimatology
City
Lasi
Country
Romania
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

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A Random Controlled Test (RCT): Acupuncture Treatment on Nonspecific Low Back Pain (NLBP)

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