Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Health & Welfare, Korea | OTHER_GOV |
| Gachon University Gil Medical Center | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized Acupuncture | Experimental | 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. |
|
| Standardized Acupuncture | Experimental | 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. |
|
| Sham acupuncture | Sham Comparator | 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. |
|
| Waiting | No Intervention | No interventions were applied to the patients in this group. Only assessments were made at each visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized Acupuncture | Procedure | The treatment was applied twice a week for 20 minutes for 6 weeks(12sessions) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dongwoo Nam, Ph.D. | Contact | +82-2-958-1827 | hanisanam@hanmail.net |
| Name | Affiliation | Role |
|---|---|---|
| Jae-Dong Lee, Ph.D | Kyunghee University Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Oriental Medicine Hospital | Recruiting | Seoul | Seoul | 130-872 | South Korea |
Not provided
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standardized Acupuncture | Procedure | 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 | Procedure | 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. |
|
|
| Waiting | Other | No interventions were applied to the patients in this group. |
|
|
| 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 |
| 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) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |