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Clinical trial to evaluate the efficacy and safety of MS-980S medical device in patients with chronic low back pain

A 4-weeks randomized, single-blind, parallel designed exploratory clinical trial to evaluate the efficacy and safety of MS-980S medical device in patients with chronic low back pain

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CRIS
Registry ID
KCT0003122
Enrollment
40
Registered
2018-08-24
Start date
2018-11-01
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Experimental group(thermal therapy group)&gt
1. We used medical thermal device(MS-980S). 2. Number of treatment: total 8 times(twice a week/total 4 weeks) 3. Application time: 30~60 minutes depending on the patient&#39
s syptoms &lt
1. We used medical thermal device(MS-980S). But It is applied at a temperature that can not be recognized, and is not exposed to far infrared rays.

Sponsors

Wonkwang University, Gwangju Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. An adult male and female who are over 19 years of age. Patients with back pain over 3 months(12weeks) 2. Paitents with over 40 score on100mm Visual Analoges Scale (VAS) 3. A patient who fully understands of the test and the risks involved in taking the test and is able to communicate with the examiner well and follow the test compliance 4. The person who signed the agreement with the explanation of the purpose, method and effect of the clinical trial

Exclusion criteria

Exclusion criteria: 1. Patients with a history of trauma and surgery in the last 6 months 2. Patients with systemic diseases that cause chronic back pain (cancer, infection, etc.) 3. Patients with burns, tattoos, subcutaneous haemorrhage, and severe skin conditions requiring clinical treatment 4. Mental illness to affect pain and questionnaire 5. Those who have received chronic back pain treatment (medication, korean medicine, physical therapy, etc.) during the last 4 weeks 6. Patients with neurological disease (stroke, peripheral neuropathy, etc.) whose sensation of temperature is poor due to paralysis in local or systemic sensations 7. Subjects with hypersensitivity to thermal stimulation, laser, and high frequency 8. People with a history of alcohol or substance abuse within 12 months 9. Infants, pregnant women, people with a pregnancy plan, lactating women 10. Those who have participated in other clinical trials after this clinical trial enrollment/ Those who participated in clinical trials for back pain within 3 months 11. Those using electronic medical devices for hypertension and electrocardiograph 12.Those who were considered as unsuitable for participation by the researcher

Design outcomes

Primary

MeasureTime frame
100mm VAS(visual analoge scale)

Secondary

MeasureTime frame
Ratio of subjects whose 100mm VAS(visual analoge scale) has decreased by more than 50%;Change of ODI (Oswestry Low Back Pain Disability Questionnaire/Oswestry Disability Index);Change of SF(Short-Foam) 36 health survey;Patient satisfaction survey

Countries

Korea, Republic of

Contacts

Public ContactYoung Kwon

Wonkwang University, Gwangju Medical Center

exeterin@naver.com+82-62-670-6451

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026