Back to resultsClinical Study to Evaluate the Safety and Efficacy of Heating and Cooling Combination Therapeutic Device(OCH-S100)
Primary Purpose
Chronic Low Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Heating and cooling combination therapy
Sham heating and cooling therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Chronic low back pain, Heating and cooling combination therapeutic device, Heating and cooling combination therapy, Contrast therapy
Eligibility Criteria
Inclusion Criteria:
- At least 20 years of age, but below 75 years of age
- Low back pain in the last 3 months or more
- Low back pain rated over 40 mm on a 100 mm Visual Analog Scale (VAS)
- Those who are reliable and willing to cooperate in this test, and obey the restrictions for the treatment period.
- An understanding of the objectives, methods and efficacy of the clinical trial, and willingness in completing the consent form.
Exclusion Criteria:
- Trauma to or surgery on the lumbar region within 6 months prior to enrollment
- Low back pain accompanied by sciatica
- Systematic disease, and severe dysfunction due to the medical illness (e.g. cancer, infection, etc.)
- A history of medication, oriental medical treatment, physiotherapy for treating low back pain within the last 4 weeks
- Neurological disease, such as topical or whole body hypoesthesia in temperature sensation (e.g. stroke, peripheral neuropathy, etc.)
- Hypersensitivity in heating and cooling stimulation
- Pregnant and lactating women
- Participate in the other clinical trials within the last 3 months or after enroll this trial
- When researchers evaluate that it is not appropriate to participate in this clinical test
Sites / Locations
- Donnguk University Oriental Medical HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Heating and cooling combination therapy
Sham heating and cooling therapy
Arm Description
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℃.
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.
Outcomes
Primary Outcome Measures
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'
Secondary Outcome Measures
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'
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02289170
First Posted
October 14, 2014
Last Updated
November 9, 2014
Sponsor
Eun Jung Kim
Collaborators
Ministry of Health & Welfare, Korea
1. Study Identification
Unique Protocol Identification Number
NCT02289170
Brief Title
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
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eun Jung Kim
Collaborators
Ministry of Health & Welfare, Korea
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Chronic low back pain, Heating and cooling combination therapeutic device, Heating and cooling combination therapy, Contrast therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Heating and cooling combination therapy
Arm Type
Experimental
Arm Description
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℃.
Arm Title
Sham heating and cooling therapy
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Heating and cooling combination therapy
Other Intervention Name(s)
OCH-S100
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham heating and cooling therapy
Other Intervention Name(s)
OCH-S100
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in 100mm Pain Visual Analogue Scale (VAS)
Description
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
Secondary Outcome Measure Information:
Title
Change from baseline in 100mm Pain Visual Analogue Scale (VAS)
Description
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
Title
Change from baseline in Korean Oswestry disability index (KODI)
Description
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
Title
Change from baseline in Korean Roland Morris Disability Questionnaire (KRMDQ)
Description
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
Title
Change from baseline in Traditional Medicine Back pain Questionnaire (TMBQ)
Description
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
Title
Change from baseline in Modified schöber test
Description
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
Title
Change from baseline in Finger-to-floor distance
Description
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
Title
Change from baseline in Finger-to-thigh distraction
Description
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
Title
Adverse Events
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 20 years of age, but below 75 years of age
Low back pain in the last 3 months or more
Low back pain rated over 40 mm on a 100 mm Visual Analog Scale (VAS)
Those who are reliable and willing to cooperate in this test, and obey the restrictions for the treatment period.
An understanding of the objectives, methods and efficacy of the clinical trial, and willingness in completing the consent form.
Exclusion Criteria:
Trauma to or surgery on the lumbar region within 6 months prior to enrollment
Low back pain accompanied by sciatica
Systematic disease, and severe dysfunction due to the medical illness (e.g. cancer, infection, etc.)
A history of medication, oriental medical treatment, physiotherapy for treating low back pain within the last 4 weeks
Neurological disease, such as topical or whole body hypoesthesia in temperature sensation (e.g. stroke, peripheral neuropathy, etc.)
Hypersensitivity in heating and cooling stimulation
Pregnant and lactating women
Participate in the other clinical trials within the last 3 months or after enroll this trial
When researchers evaluate that it is not appropriate to participate in this clinical test
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eun Jung Kim, Ph.D.
Phone
82-31-710-3751
Email
hanijjung@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung Deok Lee, Ph.D.
Organizational Affiliation
Donnguk University Oriental Medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Donnguk University Oriental Medical Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
463-865
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun Jung Kim, Ph.D.
Phone
82-31-710-3751
Email
hanijjung@naver.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
26112148
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.
Results Reference
derived
Learn more about this trial
Clinical Study to Evaluate the Safety and Efficacy of Heating and Cooling Combination Therapeutic Device(OCH-S100)
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