Efficacy and Safety Study of Individualized and Standardized Acupuncture Treatment for Low Back Pain
Recruitment status was: Recruiting
|Low Back Pain||Procedure: Individualized Acupuncture Procedure: Standardized Acupuncture Procedure: Sham Acupuncture Other: Waiting||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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|
- The change of 100mm pain Visual Analog Scale(VAS) after 6 weeks of treatment. [ Time Frame: 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.
- Roland - Morris Disability Questionnaire [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
|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)|
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 Name: Park Sham Device
No Intervention: Waiting
No interventions were applied to the patients in this group. Only assessments were made at each visit.
No interventions were applied to the patients in this group.
Other Name: No interventions
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570127
|Contact: Dongwoo Nam, Ph.D.||+firstname.lastname@example.org|
|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 email@example.com|
|Sub-Investigator: Dongwoo Nam, Ph.D|
|Study Chair:||Jae-Dong Lee, Ph.D||Kyunghee University Medical Center|