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

March 18, 2010 updated by: Beijing Hospital of Traditional Chinese Medicine

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

Hypothesis: Acupuncture procedure of He's Santong Methods could be an option to treat nonspecific low back pain.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

534

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100010
        • Recruiting
        • Beijing TCM Hospital
        • Contact:
  • Romania
      • Lasi, Romania
        • Active, not recruiting
        • Hospital CF Iasi, Clinic of Rehabilitation Medicine, Phys. Med., Balneoclimatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Verus acupuncture
Other: Acupuncture Treatment
Acupuncture is a technique of inserting and manipulating fine needles into specific points on the body to relieve pain or for therapeutic purposes.
SHAM_COMPARATOR: Sham acupuncture
Other: Sham acupuncture
Sham acupuncture is inserting needles superficially, without manipulating, into specific points on the body.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Score of SF-36
Time Frame: 4 weeks, 8 weeks, 12 weeks, 24 weeks
4 weeks, 8 weeks, 12 weeks, 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Oswestry Disability Index (ODI)
Time Frame: 4 weeks, 8 weeks, 12 weeks, 24 weeks
4 weeks, 8 weeks, 12 weeks, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Hospital of Traditional Chinese Medicine

Investigators

  • Study Chair: Linpeng Wang, M.D., Beijing TCM Hospital
  • Principal Investigator: Stratulat Ioan Sorin, M.D., Hospital CF Iasi, Clinic of Rehabilitation Medicine, Phys. Med., Balneoclimatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ANTICIPATED)

November 1, 2010

Study Completion (ANTICIPATED)

November 1, 2011

Study Registration Dates

First Submitted

January 13, 2010

First Submitted That Met QC Criteria

January 13, 2010

First Posted (ESTIMATE)

January 14, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 19, 2010

Last Update Submitted That Met QC Criteria

March 18, 2010

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JKH 081

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Low Back Pain

Clinical Trials on Acupuncture Treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe