Clinical trial NCT02289170: Clinical Study to Evaluate the Safety and Efficacy of Heating and Cooling Combination Therapeutic Device(OCH-S100)
Official title: A Randomized, Double-blind, Multicenter, Parallel Designed Clinical Study to Evaluate the Safety and Efficacy of Heating and Cooling Combination Therapeutic Device(OCH-S100) in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Chronic low back pain
Heating and cooling combination therapeutic device
Heating and cooling combination therapy
Contrast therapy
Lead sponsor: DongGuk University
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Welfare, Korea
First posted: 2014-11-13
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to verify the efficacy and safety of heating and cooling combination therapeutic device (OCH-S100) for patients with chronic low back pain (LBP).

Detailed description: The investigators targeted the patients with chronic LBP. After treatment in 2 groups - real heating and cooling combination treatment and sham heating and cooling combination treatment - the investigators will compare the effects of pain relief and improvement in disability and range of motion of lumbar region. So the investigators will confirm the efficacy of heating and cooling combination therapy, and further the best treatment method. In addition, the investigators are going to evaluate the safety of abnormal reaction during the treatment.

Eligibility criteria: Inclusion Criteria:

1. At least 20 years of age, but below 75 years of age
2. Low back pain in the last 3 months or more
3. Low back pain rated over 40 mm on a 100 mm Visual Analog Scale (VAS)
4. Those who are reliable and willing to cooperate in this test, and obey the restrictions for the treatment period.
5. An understanding of the objectives, methods and efficacy of the clinical trial, and willingness in completing the consent form.

Exclusion Criteria:

1. Trauma to or surgery on the lumbar region within 6 months prior to enrollment
2. Low back pain accompanied by sciatica
3. Systematic disease, and severe dysfunction due to the medical illness (e.g. cancer, infection, etc.)
4. A history of medication, oriental medical treatment, physiotherapy for treating low back pain within the last 4 weeks
5. Neurological disease, such as topical or whole body hypoesthesia in temperature sensation (e.g. stroke, peripheral neuropathy, etc.)
6. Hypersensitivity in heating and cooling stimulation
7. Pregnant and lactating women
8. Participate in the other clinical trials within the last 3 months or after enroll this trial
9. When researchers evaluate that it is not appropriate to participate in this clinical test

Primary outcomes:
measure: Change from baseline in 100mm Pain Visual Analogue Scale (VAS)
timeFrame: at baseline and 4 4 weeks later from baseline
Secondary outcomes:
measure: Change from baseline in 100mm Pain Visual Analogue Scale (VAS)
timeFrame: estimately every 2.8 days from baseline to 4 weeks later, and 4 weeks later from the end of treatment
measure: Change from baseline in Korean Oswestry disability index (KODI)
timeFrame: at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
measure: Change from baseline in Korean Roland Morris Disability Questionnaire (KRMDQ)
timeFrame: at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
measure: Change from baseline in Traditional Medicine Back pain Questionnaire (TMBQ)
timeFrame: at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
measure: Change from baseline in Modified schöber test
timeFrame: at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
measure: Change from baseline in Finger-to-floor distance
timeFrame: at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
measure: Change from baseline in Finger-to-thigh distraction
timeFrame: at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
measure: Adverse Events
timeFrame: estimately every 2.8 days from baseline to 4 weeks later, and 4 weeks later from the end of treatment
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Donnguk University Oriental Medical Hospital
state: Gyeonggi-do
Study officials:
affiliation: Donnguk University Oriental Medical center
name: Seung Deok Lee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim EJ, Choi YD, Lim CY, Kim KH, Lee SD. Effect of heating and cooling combination therapy on patients with chronic low back pain: study protocol for a randomized controlled trial. Trials. 2015 Jun 26;16:285. doi: 10.1186/s13063-015-0800-4.