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

9 november 2014 uppdaterad av: 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).

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

80

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Korea, Republiken av
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republiken av, 463-865
        • Rekrytering
        • Donnguk University Oriental Medical Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

20 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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℃.
Enhet: 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.
Andra namn:
  • 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.
Enhet: 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.
Andra namn:
  • OCH-S100

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from baseline in 100mm Pain Visual Analogue Scale (VAS)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from baseline in 100mm Pain Visual Analogue Scale (VAS)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Eun Jung Kim

Samarbetspartners

Ministry of Health & Welfare, Korea

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2014

Primärt slutförande (Förväntat)

1 september 2015

Avslutad studie (Förväntat)

1 september 2015

Studieregistreringsdatum

Först inskickad

14 oktober 2014

Först inskickad som uppfyllde QC-kriterierna

9 november 2014

Första postat (Uppskatta)

13 november 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

13 november 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 november 2014

Senast verifierad

1 november 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • OCH-S100-2014
  • HI11C2135 (Annat bidrag/finansieringsnummer: The Korea Health Industry Development Institute)

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