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

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

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.

Study Overview

• Status: Unknown
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: Individualized Acupuncture; Procedure: Standardized Acupuncture; Procedure: Sham Acupuncture; Other: Waiting

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 Type: Interventional
• Enrollment (Anticipated): 276
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Dongwoo Nam, Ph.D.; Phone Number: +82-2-958-1827; Email: hanisanam@hanmail.net

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 130-872
    • Recruiting
    • Kyung Hee University Oriental Medicine Hospital
    • Contact: Dongwoo Nam, Ph.D; Phone Number: +82-2-958-1827; Email: hanisanam@hanmail.net
    • Sub-Investigator: Dongwoo Nam, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Individualized Acupuncture; The treatment was applied twice a week for 20 minutes for 6 weeks(12sessions)
Experimental: 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.	Procedure: Standardized Acupuncture; The treatment was applied twice a week for 20 minutes for 6 weeks(12sessions) 8 Acupuncture points, GV4, GV3, BL24(bilateral), BL25(bilateral) and GB30(bilateral) were used for all the patients assigned to this group. Sterile Stainless Steel(25mm x 40mm) disposable acupuncture needles manufactured by Dong-Bang Acupuncture Co.(Korea) were used.
Sham Comparator: 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.	Procedure: Sham Acupuncture; The treatment was applied twice a week for 6 weeks(12sessions). The sham acupuncture was applied on the 8 same acupuncture points as in the standardized acupuncture group, GV4, GV3, BL24(bilateral), BL25(bilateral) and GB30(bilateral). Each session was 20 minutes long.; Other Names: Park Sham Device
No Intervention: Waiting; No interventions were applied to the patients in this group. Only assessments were made at each visit.	Other: Waiting; No interventions were applied to the patients in this group.; Other Names: No interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of 100mm pain Visual Analog Scale(VAS) 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.	at baseline and after 6 weeks of treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Roland - Morris Disability Questionnaire	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.	at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit
SF-36	The 36 questions yields an 8-scale health profile. It is useful in monitoring the change in health related quality of life.	at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit
Adverse Events	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.	at 2nd(baseline), 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, 11th, 12th and 13th(end of study)

Collaborators and Investigators

• Sponsor: Dongwoo Nam
• Collaborators: Gachon University Gil Medical Center; Ministry of Health & Welfare, Korea
• Investigators: Study Chair: Jae-Dong Lee, Ph.D, Kyunghee University Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): August 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: March 26, 2012
• First Submitted That Met QC Criteria: April 1, 2012
• First Posted (Estimate): April 4, 2012

Study Record Updates

• Last Update Posted (Estimate): April 6, 2012
• Last Update Submitted That Met QC Criteria: April 5, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Low Back Pain; Randomized Controlled Trial; Individualized Acupuncture; Standardized Acupuncture
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: KOMCIRB-02-20101130-02