ClinicalTrials.gg
Status unknownNCT02289170Updated Nov 13, 2014

Clinical Study to Evaluate the Safety and Efficacy of Heating and Cooling Combination Therapeutic Device(OCH-S100)

An interventional study of Heating and cooling combination therapy and Sham heating and cooling therapy in Chronic Low Back Pain, sponsored by Eun Jung Kim. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-11-13.

Sponsored by Eun Jung Kim · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2014), so the status shown — last known as Recruiting — may be out of date.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 60 studies in Low Back Pain with a site in Korea, Republic of — 9 open to participants now, 11 under way, none of them phase 3. Low Back Pain · Korea, Republic of.

Planned enrollment
21st of 47
80 · median 70
Started
2014
with 4 others
No phase
27 of 60
3 open now
Registered
20th of 60
by date

Among the 60 studies in Low Back Pain with a site in Korea, Republic of, this one is the 21st largest by planned enrollment of the 47 interventional ones that give a count, is one of 5 that started in 2014, is one of 27 with no phase, and was the 20th registered.

Low Back Pain

2,923 studies on the registry are indexed under Low Back Pain; 579 are open to participants now.

Browse Low Back Pain studies →

Open to participants now

9 of the 60 studies in Low Back Pain with a site in Korea, Republic of are open now. Recruiting first, the newest first:

4 more — sign in →

All 9 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 332 Low Back Pain studies recruiting now, 92 (28%) set no upper age limit and 210 (63%) stop at 75 or younger; 8 take children under 18; 46 take healthy volunteers.

This study: 20 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 60 studies in Low Back Pain with a site in Korea, Republic of, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Chronic Low Back Pain

Browse trials for

Keywords

  • Chronic low back pain
  • Heating and cooling combination therapeutic device
  • Heating and cooling combination therapy
  • Contrast therapy
04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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. 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Heating and cooling combination therapy

    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℃.

    Device: Heating and cooling combination therapy

  • Sham comparator
    Sham heating and cooling therapy

    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.

    Device: Sham heating and cooling therapy

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.

    Also known as: OCH-S100

  • 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.

    Also known as: OCH-S100

06

What researchers measure

Primary outcomes

  1. 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: at baseline and 4 4 weeks later from baseline

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

07

Study locations

1 of 1 sites recruiting
  • Donnguk University Oriental Medical Hospital
    Seongnam, Gyeonggi-do 463-865, Korea, Republic of
    Recruiting
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2014, a primary completion of Sep 2015 and a completion of Sep 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 14, 2014
First posted
Nov 13, 2014
Start
Sep 2014
Primary completionEst.
Sep 2015
CompletionEst.
Sep 2015
Last update
Nov 13, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02289170
Lead sponsor
Eun Jung Kim
Collaborators
Ministry of Health & Welfare, Korea
Responsible party
Eun Jung Kim (Clinical trial Chief of Research, DongGuk University) — Sponsor-investigator
First posted
Nov 13, 2014
Start date
Sep 2014
Primary completion
Sep 2015 (estimated)
Completion
Sep 2015 (estimated)
Last update
Nov 13, 2014

Study contacts

Eun Jung Kim, Ph.D.
Contact
hanijjung@naver.com
82-31-710-3751
Seung Deok Lee, Ph.D.
principal investigator · Donnguk University Oriental Medical center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion