The Effect of Acupuncture in Treating Chronic Low-back Pain

Low Back Pain Clinical Trial

Official title:

The Effect of Acupuncture in Treating Chronic Low-back Pain

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02260284
• Other study ID #: 2014LBP01
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 2, 2014
• Last updated: December 5, 2017
• Start date: October 2014
• Est. completion date: October 2019

Study information

• Verified date: December 2017
• Source: Chengdu PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficiency of acupuncture in treating chronic low-back pain

Description:

We want to know if the Yaotong points penetration or standardized acupuncture mode are more effective than medical care alone for CLBP; and if Yaotong points penetration is more effective than standardized acupuncture.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 160
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• with CLBP

• without taking any other medication for the treatment of CLBP in at least 2 last weeks;

• aged from 18 to 50 years;

• without conflict to the written, informed consent signed prior to the enrollment.

Exclusion Criteria:

• pathological causes of chronic back pain (such as fractures, cancer, spinal stenosis and infections);

• complicated back problems (such as scoliologic >40° curvature, chronic spondylitis, sciatica, prior back surgery and other medicolegal issues);

• with contraindications for acupuncture (e.g., cardiac pacemakers, coagulation disfunctions, being in pregnancy, seizure disorder);

• conditions making treatment difficult (e.g., paralysis, psychoses);

• conditions that might confound treatment effects or interpretation of results (e.g., severe fibromyalgia, rheumatoid arthritis, concurrent care from other providers);

• previous acupuncture treatment for any condition.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Back Pain
• Low Back Pain
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Other:
• Yaotong points acupuncture
Patients receive the treatments of Yaotong points penetration
• the usual care
participants received no study-related care-just the care, if any, that they and their physicians chose: mostly massage and physical therapy visits and continued use of medications (mostly nonsteroidal anti-inflammatory drugs (NSAIDS))
• standardized acupuncture
Patients were given to the standardized acupuncture groups. This prescription included six acupuncture points that are commonly applied for the treatment of CLBP (Bladder 23-bilateral, Bladder 40-bilateral, and Kidney 3-bilateral) on the low back and lower leg.

Locations

Country	Name	City	State
China	General Hospital of Chengdu Military Area Command PLA	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline on modified Roland-Morris Disability Questionnaire (RMDQ) at 24 weeks	This wellvalidated questionnaire assesses pain on several dimensions including sensory pain, affective pain, and evaluative pain.	at 0 week, 12 weeks, 24 weeks
Secondary	Changes from baseline on Diagnosis and Curative Effect Standard for Syndrome of TCM for CLBP at 24 weeks	It includes curing standard, referring to LBP had disappeared and no difficulty in movement was found; effective standard, referring to the pain was relieved but slight discomfort was found; and ineffective standard, referring to no symptom improvement was found.	at 0 week, 12 weeks, 24 weeks
Secondary	Changes from baseline on short-form 36 health survey (SF-36)	Physical and mental health component summary scores of the medical outcomes	at 0 week, 12 weeks, 24 weeks
Secondary	Changes from baseline on Visual Analog Scale at 24 weeks	This rating scale involved the selection of a point along a 10-cm line, which described pain intensity on a continuum from "no painat all" to "pain as bad as it could be." This scale has been found to be an excellent measure of self-reported pain	at 0 week, 12 weeks, 24 weeks