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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
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.
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.
Donnguk University Oriental Medical Hospital
Seongnam-si, Gyeonggi-do, South Korea
RECRUITINGChange 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'
Time frame: at baseline and 4 4 weeks later from baseline
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'
Time frame: estimately every 2.8 days from baseline to 4 weeks later, and 4 weeks later from the end of treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: estimately every 2.8 days from baseline to 4 weeks later, and 4 weeks later from the end of treatment