NCT02289170

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 14, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 13, 2014

Status Verified

November 1, 2014

Enrollment Period

1 year

First QC Date

October 14, 2014

Last Update Submit

November 9, 2014

Conditions

Chronic Low Back Pain

Keywords

Chronic low back painHeating and cooling combination therapeutic deviceHeating and cooling combination therapyContrast therapy

Outcome Measures

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'

    at baseline and 4 4 weeks later from baseline

Secondary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • 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

  • +3 more secondary outcomes

Study Arms (2)

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℃.

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.

Device: Sham heating and cooling therapy

Interventions

Heating and cooling combination therapyDEVICE

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
Heating and cooling combination therapy
Sham heating and cooling therapyDEVICE

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
Sham heating and cooling therapy

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Donnguk University Oriental Medical Hospital

Seongnam-si, Gyeonggi-do, 463-865, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26112148DERIVED

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Seung Deok Lee, Ph.D.

    Donnguk University Oriental Medical center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eun Jung Kim, Ph.D.

CONTACT

82-31-710-3751hanijjung@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical trial Chief of Research

Study Record Dates

First Submitted

October 14, 2014

First Posted

November 13, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

November 13, 2014

Record last verified: 2014-11

Locations

KR(1)