Condition category
Musculoskeletal Diseases
Date applied
07/04/2011
Date assigned
10/06/2011
Last edited
10/06/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Yun-Yeop Cha

ORCID ID

Contact details

283 Woo-San Dong
Wonju
220-717
Korea
South

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N2010-02

Study information

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

Acronym

Study hypothesis

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

Sang-ji University Oriental Medical Centre Ethics Committee approved on 2nd September 2010

Study design

Randomised patient-assessor blind two arm sham device controlled unicentre pilot trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

03/09/2010

Overall trial end date

02/09/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

38

Participant 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

Recruitment start date

03/09/2010

Recruitment end date

02/09/2011

Locations

Countries of recruitment

Korea, South

Trial participating centre

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

Sponsor information

Organisation

NUGA Medical Co. Ltd (South Korea)

Sponsor details

Nuga Best
c/o Lee
Jong Soo
Building115-5 Samseong-dong
Gangnam-gu
Seoul
135-090
Korea
South

Sponsor type

Industry

Website

http://www.nugamedical.com/

Funders

Funder type

Industry

Funder name

NUGA Medical Co. Ltd (South Korea)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes