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

Not Applicable

• Conditions: Low Back Pain
• Interventions: Other: Acupuncture Treatment; Other: Sham acupuncture

• Registration Number: NCT01049074
• Lead Sponsor: Beijing Hospital of Traditional Chinese Medicine

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.

Study Timeline

• Status Verified: 2008-11
• Study Start: 2008-11
• Study First Submitted: 2010-01-13
• Study First Submitted QC: 2010-01-13
• Study First Posted: 2010-01-14
• Last Update Submitted: 2010-03-18
• Last Update Posted: 2010-03-19
• Primary Completion: 2010-11
• Study Completion: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 534

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verus acupuncture	Acupuncture Treatment	-
Sham acupuncture	Sham acupuncture	-

Primary Outcome Measures

Name	Time	Method
Score of SF-36	4 weeks, 8 weeks, 12 weeks, 24 weeks

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	4 weeks, 8 weeks, 12 weeks, 24 weeks

Trial Locations

Locations (2)

Beijing TCM Hospital; 🇨🇳 Beijing, Beijing, China

Hospital CF Iasi, Clinic of Rehabilitation Medicine, Phys. Med., Balneoclimatology; 🇷🇴 Lasi, Romania