Ankylosing Spondylitis, Low Back Pain
Conditions
Brief summary
The purpose of this study is to evaluate the efficiency of acupuncture in treating chronic low-back pain
Detailed 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.
Interventions
OTHERYaotong points acupuncture
Patients receive the treatments of Yaotong points penetration
OTHERthe 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))
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.
Sponsors
Chengdu PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline on modified Roland-Morris Disability Questionnaire (RMDQ) at 24 weeks | at 0 week, 12 weeks, 24 weeks | This wellvalidated questionnaire assesses pain on several dimensions including sensory pain, affective pain, and evaluative pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline on Diagnosis and Curative Effect Standard for Syndrome of TCM for CLBP at 24 weeks | at 0 week, 12 weeks, 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. |
| Changes from baseline on short-form 36 health survey (SF-36) | at 0 week, 12 weeks, 24 weeks | Physical and mental health component summary scores of the medical outcomes |
| Changes from baseline on Visual Analog Scale at 24 weeks | at 0 week, 12 weeks, 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 |
Countries
China
Outcome results
None listed