None listed
Conditions
Interventions
Medical Device : This clinical trial for medical devices is conducted as a parallel study after randomized into the experimental device group or the control device group, and the allocation ratio of e
Sponsors
Samsung Medical Center
Kangbuk Samsung Medical Center
Seoul Gangnam Wooridul Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Person who is aged 19 or more to less than 70, and complains subacute low back pain (1-6 months after developed). 2. Person who complains pain between 12th ribs and hips in terms of the range of low back pain. 3. Person who does not having radiating pain in infrapatellar areas within 3 days. 4. Person who does not take a spinal surgery within last 6 months. 5. Person who is not treated with steroid injection for the purpose of lumbar pain treatment within last 2 months. 6. Person who scores more than 30% in Oswestry Disability Index (ODI)(%). 7. Person who shows more than 4 in Numeric Rating Scale (NRS). 8. Person who any fracture or tumor is not observed after simple radiography
Exclusion criteria
Exclusion criteria: 1. Person who has neurological deficits of the lower extremity. 2. Based on pregnancy and urine test, person who tests positive, or is supposed to be pregnant during the study. 3. Person who has suffered from a heart disease before, or carries a pacemaker. 4. Person who inserts metallic aids into each body site (heart, bone, leg, foot, and waist, etc.). 5. Person who participates in other clinical trials or is supposed to do so during the study period. 6. Person who has a high fever (more than 38?) or turns out to be normal as a result of a blood test (leukocyte count 12,000 or more, and platelet count 50,000 or less). 7. Person who is not capable of taking part in the study because he cannot properly express the area of pain and the severity owing to cognitive hypofunction or impossibility of normal communication. 8. Person who is confirmed as an inadequate subject in participating in the study by other testers. 9. Person who is hard to apply physiotherapy devices or gel to his skin due to contact dermatitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison between the Oswestry Disability Index(ODI) groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Numeric Rating Scale(NRS) success rate, Comparison between the groups of Oswestry Disability Index(ODI) success rate (NRS success rate: the rate of patient reduced more than 50% after treatment compared to before treatment, ODI success rate: the rate of patient reduced more than 40% after treatment compared to before treatment) ;Comparison between the groups of Lumbar isometric endurance test (Sorensen test);Comparison between the groups of Up and Go test ;Comparison between the groups of Numeric Rating Scale (NRS) ;Numeric Rating Scale(NRS) success rate, Comparison between the groups of Oswestry Disability Index(ODI) success rate (NRS success rate: the rate of patient reduced more than 50% after treatment compared to before treatment, ODI success rate: the rate of patient reduced more than 40% after treatment compared to before treatment) ;Comparison between the groups with North American Spine Society(NASS) 4 point patients satisfaction index;Comparison between the groups of Lumbar isometric endurance test (Sorensen test);Comparison of drug administration frequency and quantity;Comparison between the groups of Up and Go test ;Based on the MRI result of back muscle, comparison of the alteration of T2 signal (using CNR), DWI signal (b=0, b=800), and ADC value, and comparison between the groups of these results.;Comparison between the groups with North American Spine Society(NASS) 4 point patients satisfaction index;Comparison of the muscle contraction latent period of the back muscle (erector spinae, multifidus) measured at the time of sudden motion of the upper limbs, and comparison between the groups of the period (Comparison between the groups of MRI and muscle contraction latent period is conducted, and it is supposed to be analyzed.) ;Based on the MIR result of back muscle, comparison of the alteration of T2 signal (using CNR), DWI signal (b=0, b=800), and ADC value, and comparison between the groups of these results | — |
Countries
Korea, Republic of
Contacts
Public ContactMieun Kim
Samsung Medical Center
Outcome results
None listed