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| ID | Type | Description | Link |
|---|---|---|---|
| HI11C2135 | Other Grant/Funding Number | The Korea Health Industry Development Institute |
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| Name | Class |
|---|---|
| Ministry of Health & Welfare, Korea | OTHER_GOV |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heating and cooling combination therapy | Experimental | 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℃. |
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| Sham heating and cooling therapy | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heating and cooling combination therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 100mm Pain Visual Analogue Scale (VAS) | The patient is asked to indicate their perceived pain intensity along a 100 mm horizontal line, where '0' represents 'no pain' and '100', 'unbearable pain' | at baseline and 4 4 weeks later from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 100mm Pain Visual Analogue Scale (VAS) | The patient is asked to indicate their perceived pain intensity along a 100 mm horizontal line, where '0' represents 'no pain' and '100', 'unbearable pain' | estimately every 2.8 days from baseline to 4 weeks later, and 4 weeks later from the end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eun Jung Kim, Ph.D. | Contact | 82-31-710-3751 | hanijjung@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Seung Deok Lee, Ph.D. | Donnguk University Oriental Medical center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Donnguk University Oriental Medical Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 463-865 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26112148 | Derived | 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. |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Sham heating and cooling therapy | Device | 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. |
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| Change from baseline in Korean Oswestry disability index (KODI) |
KODI is checked by the patients. KODI is a questionnaire to measure the back-related disability. KODI consists of combination of physical and social restriction through 9 questions covering different dimensions of daily living. |
| at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment |
| Change from baseline in Korean Roland Morris Disability Questionnaire (KRMDQ) | KRMDQ is checked by the patients. KRMDQ is a questionnaire to measure the back-related disability. KRMDQ consists of 24 questions answered yes or no. | at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment |
| Change from baseline in Traditional Medicine Back pain Questionnaire (TMBQ) | TMBQ is checked by the patients. TMBQ is a questionnaire to measure the back-related disability in aspect of oriental medicine. | at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment |
| Change from baseline in Modified schöber test | Modified schöber test measures the flexion range of motion of lumbar spine. First, investigator marks the point at patients' lumbosacral junction. Then also marks the points at upper 10cm and lower 5cm of the former point in standing position. After marking the 3 points, patients bend anteriorly as best he or she can. Then, investigator measures the length of the latter 2 points. | at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment |
| Change from baseline in Finger-to-floor distance | Finger-to-floor distance measures the flexion range of motion of lumbar spine. Patients stand on the box which height is 20cm. Then, patients bend anteriorly in extension of knee and upper limb. Investigator measures the length from floor to 3rd finger. | at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment |
| Change from baseline in Finger-to-thigh distraction | Finger-to-thigh distraction measures the lateral bending range of motion of lumbar spine. Patients stand on the box which height is 20cm. Then, patients bend laterally in extension of knee and upper limb. Investigator measures the length from floor to 3rd finger. | at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment |
| Adverse Events | Any unpredicted symptoms were checked at each follow up visit and if any, the symptom, time of occurrence, and length of duration were recorded and reported. | estimately every 2.8 days from baseline to 4 weeks later, and 4 weeks later from the end of treatment |