Chronic Low Back Pain
Conditions
Keywords
Chronic low back pain, Heating and cooling combination therapeutic device, Heating and cooling combination therapy, Contrast therapy
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.
Interventions
DEVICEHeating 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.
DEVICESham 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.
Sponsors
Ministry of Health & Welfare, Korea
Eun Jung Kim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in 100mm Pain Visual Analogue Scale (VAS) | at baseline and 4 4 weeks later from baseline | 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' |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Korean Oswestry disability index (KODI) | at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment | 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. |
| Change from baseline in Korean Roland Morris Disability Questionnaire (KRMDQ) | at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment | 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. |
| Change from baseline in Traditional Medicine Back pain Questionnaire (TMBQ) | at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment | TMBQ is checked by the patients. TMBQ is a questionnaire to measure the back-related disability in aspect of oriental medicine. |
| Change from baseline in 100mm Pain Visual Analogue Scale (VAS) | estimately every 2.8 days from baseline to 4 weeks later, and 4 weeks later from the end of treatment | 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' |
| Change from baseline in Finger-to-floor distance | at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment | 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. |
| Change from baseline in Finger-to-thigh distraction | at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment | 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. |
| Adverse Events | estimately every 2.8 days from baseline to 4 weeks later, and 4 weeks later from the end of treatment | 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. |
| Change from baseline in Modified schöber test | at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment | 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. |
Countries
South Korea
Contacts
Primary ContactEun Jung Kim, Ph.D.
Outcome results
None listed