The study of NUGA MRT-II relief for low back muscular pain

ISRCTN	ISRCTN13816277
DOI	https://doi.org/10.1186/ISRCTN13816277
Protocol serial number	N2010-02
Sponsor	NUGA Medical Co. Ltd (South Korea)
Funder	NUGA Medical Co. Ltd (South Korea)

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

283 Woo-San Dong
Wonju
220-717
Korea, South

Study information

Primary study design	Interventional
Study design	Randomised patient-assessor blind two arm sham device controlled unicentre pilot trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Visual analogue scale (VAS) for bothersomeness : measured at baseline, every visit during 2 weeks and after 3 weeks
Key secondary outcome measure(s)	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
Completion date	02/09/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes