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

Low Back Pain Clinical Trial

— ANLBP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01049074
• Other study ID #: JKH 081
• Status: Recruiting
• Phase: N/A
• First received: January 13, 2010
• Last updated: March 18, 2010
• Start date: November 2008
• Est. completion date: November 2011

Study information

• Verified date: November 2008
• Source: Beijing Hospital of Traditional Chinese Medicine
• Contact: Peng Chen, M.D.
• Phone: 86-10-52176636
• Email: chenpenger[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 534
• Est. completion date: November 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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 acupuncture
Sham acupuncture is inserting needles superficially, without manipulating, into specific points on the body.

Locations

Country	Name	City	State
China	Beijing TCM Hospital	Beijing	Beijing
Romania	Hospital CF Iasi, Clinic of Rehabilitation Medicine, Phys. Med., Balneoclimatology	Lasi

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Hospital of Traditional Chinese Medicine

Countries where clinical trial is conducted

China,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of SF-36		4 weeks, 8 weeks, 12 weeks, 24 weeks	No
Secondary	Oswestry Disability Index (ODI)		4 weeks, 8 weeks, 12 weeks, 24 weeks	No