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
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 276
- Locations
- 1
- Primary Endpoint
- The change of 100mm pain Visual Analog Scale(VAS) after 6 weeks of treatment.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Individualized Acupuncture (Procedure)
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.
Intervention: Standardized Acupuncture (Procedure)
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.
Intervention: Sham Acupuncture (Procedure)
Waiting
No interventions were applied to the patients in this group. Only assessments were made at each visit.
Intervention: Waiting (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Roland - Morris Disability Questionnaire(at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit)
- SF-36(at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit)
- Adverse Events(at 2nd(baseline), 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, 11th, 12th and 13th(end of study))
Investigators
Dongwoo Nam
Assistant Professor
Kyunghee University Medical Center