Efficacy and Safety Study of Individualized and Standardized Acupuncture Treatment for Low Back Pain

Phase 2

• Conditions: Low Back Pain
• Interventions: Procedure: Individualized Acupuncture; Procedure: Standardized Acupuncture; Procedure: Sham Acupuncture; Other: Waiting

• Registration Number: NCT01570127
• Lead Sponsor: Dongwoo Nam

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2012-03-26
• Status Verified: 2012-04
• Study First Submitted QC: 2012-04-01
• Study First Posted: 2012-04-04
• Last Update Submitted: 2012-04-05
• Last Update Posted: 2012-04-06
• Primary Completion: 2012-08
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 276

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individualized Acupuncture	Individualized Acupuncture	The patients in this group received individualized acupuncture prescribed by a certified Korean Medicine Doctor with more than 6 years of oriental medicine college education and 2 years of clinical experience. The acupuncture formulas were composed based on the pattern diagnosis, which is an unique diagnosis system of Oriental Medicine.
Standardized Acupuncture	Standardized Acupuncture	The patients in this group received standardized acupuncture treatment using the same acupuncture points, applied by a certified Korean Medicine Doctor with more than 6 years of oriental medicine college education and 2 years of clinical experience. The acupuncture formulas were composed based on literature review of RCTs.
Sham acupuncture	Sham Acupuncture	Non-penetrating acupuncture device, Park-sham acupuncture, was applied to the patients. The appearance of the acupuncture is same but the needles do not penetrate the skin.
Waiting	Waiting	No interventions were applied to the patients in this group. Only assessments were made at each visit.

Primary Outcome Measures

Name	Time	Method
The change of 100mm pain Visual Analog Scale(VAS) after 6 weeks of treatment.	at baseline and after 6 weeks of treatment.	Visual analog scale (VAS) is a tool used to measure pain. The patient is asked to indicate their perceived pain intensity along a 100 mm horizontal line, where '0' represents 'no pain' and '100', 'unbearable pain'. The change of pain will be reported by comparing the mean VAS before treatment and after the 6 week trearment period.

Secondary Outcome Measures

Name	Time	Method
Roland - Morris Disability Questionnaire	at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit	Roland - Morris Disability Questionnaire (RMDQ) is scored by adding up the number of items checked by the patients, among the 24 items concerning various disablilities caused by low back pain. The score can therefore vary from 0 to 24. Higher the scores represent worse disabilities.
SF-36	at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit	The 36 questions yields an 8-scale health profile. It is useful in monitoring the change in health related quality of life.
Adverse Events	at 2nd(baseline), 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, 11th, 12th and 13th(end of study)	Any unpredicted symptoms were checked at each follow up visit and if any, the symptom, time of occurrence, and length of duration were recorded and reported.

Trial Locations

Locations (1)

Kyung Hee University Oriental Medicine Hospital; 🇰🇷 Seoul, Korea, Republic of