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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01570127
• Other study ID #: KOMCIRB-02-20101130-02
• Status: Recruiting
• Phase: Phase 2
• First received: March 26, 2012
• Last updated: April 5, 2012
• Start date: October 2010
• Est. completion date: December 2012

Study information

• Verified date: April 2012
• Source: Kyunghee University Medical Center
• Contact: Dongwoo Nam, Ph.D.
• Phone: +82-2-958-1827
• Email: hanisanam[@]hanmail.net
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review BoardKorea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 276
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Procedure:
• Individualized Acupuncture
The treatment was applied twice a week for 20 minutes for 6 weeks(12sessions)
• 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 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:
• Waiting
No interventions were applied to the patients in this group.

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Oriental Medicine Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Dongwoo Nam	Gachon University Gil Medical Center, Ministry of Health & Welfare, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No
Secondary	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	No
Secondary	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)	Yes