Clinical trial NCT01570127: Efficacy and Safety Study of Individualized and Standardized Acupuncture Treatment for Low Back Pain
Official title: Clinical Trial to Evaluate and Compare the Efficacy and Safety of Individualized and Standardized Acupuncture for Low Back Pain Patients: Randomized, Double-blind, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Low Back Pain
Keywords: Individualized Acupuncture
Standardized Acupuncture
Low Back Pain
Randomized Controlled Trial
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Welfare, Korea
name: Gachon University Gil Medical Center
First posted: 2012-04-04
Enrollment: 276
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether acupuncture treatment(Individualized \& Standardized Acupuncture) is more effective than control (sham acupuncture or no treatment) and also whether individualized acupuncture is more effective than standardized acupuncture.

Detailed description: To determine whether individualized acupuncture is more effective than standardized acupuncture, 276 Low Back Pain patients will be recruited and randomly assigned to 4 separate groups.

Experimental groups(Individualized Acupuncture Group and Standardized Acupuncture Group) and Control groups (Sham acupuncture and waiting list)

The change of pain and physical functions will be compared among the four groups.

So the efficacy of acupuncture, and the best acupuncture treatment model will be determined. Also in addition, safety and abnormal reactions of acupuncture treatments will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Male and female patients suffering Low Back Pain.
* Patients classified as Class 1(pain in the lumbar area, without radiation below the gluteal fold and in the absence of neurologic signs) or Class 2(Low back pain with radiation of pain not beyond the knee, no neurological signs) according to the Quebec Task Force System
* Suffering pain which is more than 40mm on VAS(Visual Analog Scale)
* Voluntary participants who have completed the consent.

Exclusion Criteria:

* Low back trauma history within 6 months.
* Low back surgery history within 6 months.
* Low back pain caused by malignancy, inflammatory disease, fibromyalgia, vertebral fracture, infection, juvenile scoliosis or congenital malformation.
* Pain in other parts of the body more severe than low back pain.
* Mental problems that can influence the pain or results of questionnaire.
* Diseases that can interfere absorption, metabolism and excretion of medicine.
* History of alcohol or drug abuse within 12 months of the study.
* Pregnant, breastfeeding or childbearing aged women who are not using any birth control methods.

Primary outcomes:
measure: The change of 100mm pain Visual Analog Scale(VAS) after 6 weeks of treatment.
timeFrame: at baseline and after 6 weeks of treatment.
Secondary outcomes:
measure: Roland - Morris Disability Questionnaire
timeFrame: at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit
measure: SF-36
timeFrame: at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit
measure: Adverse Events
timeFrame: at 2nd(baseline), 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, 11th, 12th and 13th(end of study)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Oriental Medicine Hospital
Study officials:
affiliation: Kyunghee University Medical Center
name: Jae-Dong Lee, Ph.D
role: STUDY_CHAIR
References: