search
Back to results

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

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Individualized Acupuncture
Standardized Acupuncture
Sham Acupuncture
Waiting
Sponsored by
Dongwoo Nam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Individualized Acupuncture, Standardized Acupuncture, Low Back Pain, Randomized Controlled Trial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kyung Hee University Oriental Medicine HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Sham Comparator

No Intervention

Arm Label

Individualized Acupuncture

Standardized Acupuncture

Sham acupuncture

Waiting

Arm Description

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.

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.

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.

No interventions were applied to the patients in this group. Only assessments were made at each visit.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
SF-36
The 36 questions yields an 8-scale health profile. It is useful in monitoring the change in health related quality of life.
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.

Full Information

First Posted
March 26, 2012
Last Updated
April 5, 2012
Sponsor
Dongwoo Nam
Collaborators
Ministry of Health & Welfare, Korea, Gachon University Gil Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01570127
Brief Title
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

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dongwoo Nam
Collaborators
Ministry of Health & Welfare, Korea, Gachon University Gil Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Individualized Acupuncture, Standardized Acupuncture, Low Back Pain, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
276 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individualized Acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Standardized Acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham acupuncture
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Waiting
Arm Type
No Intervention
Arm Description
No interventions were applied to the patients in this group. Only assessments were made at each visit.
Intervention Type
Procedure
Intervention Name(s)
Individualized Acupuncture
Intervention Description
The treatment was applied twice a week for 20 minutes for 6 weeks(12sessions)
Intervention Type
Procedure
Intervention Name(s)
Standardized Acupuncture
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham Acupuncture
Other Intervention Name(s)
Park Sham Device
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Waiting
Other Intervention Name(s)
No interventions
Intervention Description
No interventions were applied to the patients in this group.
Primary Outcome Measure Information:
Title
The change of 100mm pain Visual Analog Scale(VAS) after 6 weeks of treatment.
Description
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.
Time Frame
at baseline and after 6 weeks of treatment.
Secondary Outcome Measure Information:
Title
Roland - Morris Disability Questionnaire
Description
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.
Time Frame
at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit
Title
SF-36
Description
The 36 questions yields an 8-scale health profile. It is useful in monitoring the change in health related quality of life.
Time Frame
at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit
Title
Adverse Events
Description
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.
Time Frame
at 2nd(baseline), 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, 11th, 12th and 13th(end of study)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongwoo Nam, Ph.D.
Phone
+82-2-958-1827
Email
hanisanam@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Dong Lee, Ph.D
Organizational Affiliation
Kyunghee University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Kyung Hee University Oriental Medicine Hospital
City
Seoul
ZIP/Postal Code
130-872
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongwoo Nam, Ph.D
Phone
+82-2-958-1827
Email
hanisanam@hanmail.net
First Name & Middle Initial & Last Name & Degree
Dongwoo Nam, Ph.D

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs