Efficacy and Safety Study of Individualized and Standardized Acupuncture Treatment for Low Back Pain - Full Text View

Purpose

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.

Condition	Intervention	Phase
Low Back Pain	Procedure: Individualized Acupuncture Procedure: Standardized Acupuncture Procedure: Sham Acupuncture Other: Waiting	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Acupuncture Acute Bronchitis Back Pain

U.S. FDA Resources

Further study details as provided by Kyunghee University Medical Center:

Primary Outcome Measures:

The change of 100mm pain Visual Analog Scale(VAS) after 6 weeks of treatment. [ Time Frame: at baseline and after 6 weeks of treatment. ] [ Designated as safety issue: No ]
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:

Roland - Morris Disability Questionnaire [ Time Frame: at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit ] [ Designated as safety issue: No ]
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 [ Time Frame: at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit ] [ Designated as safety issue: No ]
The 36 questions yields an 8-scale health profile. It is useful in monitoring the change in health related quality of life.
Adverse Events [ Time Frame: at 2nd(baseline), 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, 11th, 12th and 13th(end of study) ] [ Designated as safety issue: Yes ]
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.

Estimated Enrollment:	276
Study Start Date:	October 2010
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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) Other Name: Individualized Acupuncture
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. Other Name: Standardized Acupuncture
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 Name: 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 Name: No interventions

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01570127

Contacts

Contact: Dongwoo Nam, Ph.D.

+82-2-958-1827

hanisanam@hanmail.net

Locations

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

Sponsors and Collaborators

Dongwoo Nam

Ministry of Health & Welfare, Korea

Gachon University Gil Medical Center

Investigators

Study Chair:

Jae-Dong Lee, Ph.D

Kyunghee University Medical Center

More Information

No publications provided

Responsible Party:	Dongwoo Nam, Assistant Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier:	NCT01570127 History of Changes
Other Study ID Numbers:	KOMCIRB-02-20101130-02
Study First Received:	March 26, 2012
Last Updated:	April 5, 2012
Health Authority:	South Korea: Institutional Review Board Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Kyunghee University Medical Center:

Individualized Acupuncture
Standardized Acupuncture
Low Back Pain
Randomized Controlled Trial

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013