The study of NUGA MRT-II relief for low back muscular pain
| ISRCTN | ISRCTN13816277 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13816277 |
| Secondary identifying numbers | N2010-02 |
- Submission date
- 07/04/2011
- Registration date
- 10/06/2011
- Last edited
- 10/06/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Yun-Yeop Cha
Scientific
Scientific
283 Woo-San Dong
Wonju
220-717
Korea, South
Study information
| Study design | Randomised patient-assessor blind two arm sham device controlled unicentre pilot trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | The study of NUGA MRT-II relief for low back muscular pain: a randomised, patient-assessor, blind, two arm sham device controlled pilot trial |
| Study objectives | This study aims to explore the pain relieving efficacy of NUGA MRT-II (pulsed electromagnetic fields) for low back muscular pain as a pilot study |
| Ethics approval(s) | Sang-ji University Oriental Medical Centre Ethics Committee approved on 2nd September 2010 |
| Health condition(s) or problem(s) studied | Low back muscular pain |
| Intervention | Treatment group : Treated with real equipment for 3 times a week. It takes 10 minutes for each treatment. No other treatments will be applied during this trial. Treating point : Choose lumbar acupoints (among BL23, BL24, BL25, GV3, GV4, GV5 etc.) mostly on the meridians of governor vessel and bladder meridian, where patients complain pain. Control group : Treated with false equipment for 3 times a week. It takes 10 minutes for each treatment. No other treatments will be applied during this trial. Treating point : Choose lumbar acupoints (among BL23, BL24, BL25, GV3, GV4, GV5 etc.) mostly on the meridians of governor vessel and bladder meridian, where patients complain pain. |
| Intervention type | Other |
| Primary outcome measure | Visual analogue scale (VAS) for bothersomeness : measured at baseline, every visit during 2 weeks and after 3 weeks |
| Secondary outcome measures | 1. The Korean version of the Roland-Morris disability questionnaire 2. VAS for pain intensity 3. The Korean version of Oswestry Disability Index (ODI) 4. The Korean version of EuroQol 5-Dimension (EQ-5D) 5. The Korean version of SF-36 for quality of life 6. The Korean version of Beck's depression inventory (BDI) 7. Medication use Measured at baseline, every visit during 2 weeks and after 3 weeks |
| Overall study start date | 03/09/2010 |
| Completion date | 02/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 38 |
| Key inclusion criteria | 1. Genders Eligible for Study : Both 2. Patients who have been undergo chronic low back pain for chief complain over 3 months 3. Patient whose age is from 18 to 65 4. Patients whose neurology examination is normal 5. Patients whose bothersomeness for the last week before the participation of the treatment is over Visual Analogue Scale (VAS) 5 6. Patients who are diagnosed as nonspecific low back pain |
| Key exclusion criteria | 1. Patients who have radicular pain 2. Patients who are diagnosed with specific disease which cause low back pain such as metastatic cancer, vertebral fracture, spinal infection, inflammatory spondylitis 3. Patients who are diagnosed with other chronic disease which could affect the result such as cardiovascular disease, diabetic neuropathy, active hepatitis, fibromyalagia, rheumatic arthritis, dementia, haemorrhagic disease, epilepsy 4. Patients who have had or would have spinal surgery 5. Patients who have other skeletomuscular pain as chief complain 6. Patients who have undergone acupuncture treatment for low back pain in last one month 7. Patients who are taking corticosteroids, narcotics, muscle relaxant, anticoagulant drug, herbal medicine for low back pain or other non-propal drugs |
| Date of first enrolment | 03/09/2010 |
| Date of final enrolment | 02/09/2011 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
283 Woo-San Dong
Wonju
220-717
Korea, South
220-717
Korea, South
Sponsor information
NUGA Medical Co. Ltd (South Korea)
Industry
Industry
Nuga Best
c/o Lee, Jong Soo
Building115-5 Samseong-dong
Gangnam-gu
Seoul
135-090
Korea, South
| Website | http://www.nugamedical.com/ |
|---|---|
"ROR" |
https://ror.org/02h420k27 |
Funders
Funder type
Industry
NUGA Medical Co. Ltd (South Korea)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
