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

November 9, 2014 updated by: Eun Jung Kim

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of, 463-865
        • Recruiting
        • Donnguk University Oriental Medical Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
Other Names:
  • OCH-S100
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
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.
Other Names:
  • OCH-S100

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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'
at baseline and 4 4 weeks later from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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'
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
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.
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
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.
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
TMBQ is checked by the patients. TMBQ is a questionnaire to measure the back-related disability in aspect of oriental medicine.
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
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.
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
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.
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
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.
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
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.
estimately every 2.8 days from baseline to 4 weeks later, and 4 weeks later from the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eun Jung Kim

Collaborators

Ministry of Health & Welfare, Korea

Investigators

  • Principal Investigator: Seung Deok Lee, Ph.D., Donnguk University Oriental Medical center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

October 14, 2014

First Submitted That Met QC Criteria

November 9, 2014

First Posted (Estimate)

November 13, 2014

Study Record Updates

Last Update Posted (Estimate)

November 13, 2014

Last Update Submitted That Met QC Criteria

November 9, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCH-S100-2014
  • HI11C2135 (Other Grant/Funding Number: The Korea Health Industry Development Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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