Clinical Study to Evaluate the Safety and Efficacy of Heating and Cooling Combination Therapeutic Device(OCH-S100)
NCT ID: NCT02289170
Last Updated: 2014-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2014-09-30
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Heating and cooling combination therapy
The patients in this group received heating and cooling combination therapy by a certified Korean Medicine Doctor with more than 6 years of oriental medicine college education and 2 years of clinical experience. Doctor press 8 acupuncture points which is treated in LBP patients and select the most painful 2 acupuncture points. Device's probe is attached to the acupuncture points in 15 minutes. Probe's temperature is changed 5 cycles from maximum 45℃ to minimum 15℃.
Heating and cooling combination therapy
The treatment was applied 10 times for 4 weeks. Most painful 2 points in 8 acupuncture points(both side of Bladder meridian23 (BL23), BL24, BL25, BL26) were used for all the patients assigned to this group.
Sham heating and cooling therapy
The patients in this group received sham heating and cooling combination therapy in same conditions of treatment group except the temperature. Before the treatment begin, caregiver measure the patient's skin temperature. Then probe's temperature is changed 5 cycles from 1℃ over the skin temperature to 1℃ under the skin temperature.
Sham heating and cooling therapy
The treatment was applied 10 times for 4 weeks. The sham heating and cooling combination therapy was applied on the 2 of 8 same acupuncture points as in the treatment group.
Interventions
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Heating and cooling combination therapy
The treatment was applied 10 times for 4 weeks. Most painful 2 points in 8 acupuncture points(both side of Bladder meridian23 (BL23), BL24, BL25, BL26) were used for all the patients assigned to this group.
Sham heating and cooling therapy
The treatment was applied 10 times for 4 weeks. The sham heating and cooling combination therapy was applied on the 2 of 8 same acupuncture points as in the treatment group.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
75 Years
ALL
No
Sponsors
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Ministry of Health & Welfare, Korea
OTHER_GOV
Eun Jung Kim
OTHER
Responsible Party
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Eun Jung Kim
Clinical trial Chief of Research
Principal Investigators
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Seung Deok Lee, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Donnguk University Oriental Medical center
Locations
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Donnguk University Oriental Medical Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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HI11C2135
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
OCH-S100-2014
Identifier Type: -
Identifier Source: org_study_id