Chronic Low Back PainNCT02289170
Clinical Study to Evaluate the Safety and Efficacy of Heating and Cooling Combination Therapeutic Device(OCH-S100)
A study testing Heating and cooling combination therapy in people with Chronic Low Back Pain, run by Eun Jung Kim at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Heating and cooling combination therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Donnguk University Oriental Medical Hospital
Seongnam-si, Gyeonggi-do, 463-865
Eun Jung Kim, Ph.D., 82-31-710-3751, hanijjung@naver.com
About this study
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
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).
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Heating and cooling combination therapy, Sham heating and cooling therapy
- Keywords
- Chronic low back pain, Heating and cooling combination therapeutic device, Heating and cooling combination therapy, Contrast therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heating and cooling combination therapyDevice
Also called OCH-S100
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 therapyDevice
Also called OCH-S100
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.
| Study group | Role | What they receive |
|---|---|---|
| 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℃. Receives: Device: Heating and cooling combination therapy |
| 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. Receives: Device: Sham heating and cooling therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'
Measured: at baseline and 4 4 weeks later from baseline
Secondary outcomes (8)
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'
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: estimately every 2.8 days from baseline to 4 weeks later, and 4 weeks later from the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eun Jung Kim
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Responsible party
- Sponsor-investigator, Eun Jung Kim, DongGuk University
- Investigators
- Seung Deok Lee, Ph.D., Principal investigator, Donnguk University Oriental Medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289170
- Sponsor's protocol ID
- OCH-S100-2014
- Other IDs
- HI11C2135
- Status last verified
- Nov 2014
- First submitted
- 14 Oct 2014
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26112148
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02289170
- Acronym / sponsor ID
- OCH-S100-2014
- Conditions
- Chronic Low Back Pain
- Keywords
- Chronic low back pain, Heating and cooling combination therapeutic device, Heating and cooling combination therapy, Contrast therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Eun Jung KimUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 13 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heating and cooling combination therapy | Experimental | Device: Heating and cooling combination therapyThe 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℃. |
| Sham heating and cooling therapy | Sham comparator | Device: Sham heating and cooling therapyThe 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heating and cooling combination therapyAlso: OCH-S100The 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. | Device | Heating and cooling combination therapy |
| Sham heating and cooling therapyAlso: OCH-S100The 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. | Device | Sham heating and cooling therapy |
Primary outcome
Change from baseline in 100mm Pain Visual Analogue Scale (VAS)
Time frame: 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'
8 secondary outcomes
Change from baseline in 100mm Pain Visual Analogue Scale (VAS)
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)
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)
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)
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 Modified schöber test
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
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
Time frame: at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
Adverse Events
Time frame: estimately every 2.8 days from baseline to 4 weeks later, and 4 weeks later from the end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
- Derived from this study: PubMed 26112148Kim 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung Deok Lee, Ph.D. principal investigator
Donnguk University Oriental Medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heating and cooling combination therapy in people with Chronic Low Back Pain, run by Eun Jung Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eun Jung Kim, Ph.D. (82-31-710-3751, hanijjung@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in 100mm Pain Visual Analogue Scale (VAS) (time frame: at baseline and 4 4 weeks later from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02289170, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2014.