Clinical Study to Evaluate the Safety and Efficacy of Heating and Cooling Combination Therapeutic Device(OCH-S100)
9 de noviembre de 2014 actualizado por: 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).
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
80
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Gyeonggi-do
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Seongnam, Gyeonggi-do, Corea, república de, 463-865
- Reclutamiento
- Donnguk University Oriental Medical Hospital
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Contacto:
- Eun Jung Kim, Ph.D.
- Número de teléfono: 82-31-710-3751
- Correo electrónico: hanijjung@naver.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
20 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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℃.
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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.
Otros nombres:
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Comparador falso: 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.
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline in 100mm Pain Visual Analogue Scale (VAS)
Periodo de tiempo: at baseline and 4 4 weeks later from baseline
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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'
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at baseline and 4 4 weeks later from baseline
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline in 100mm Pain Visual Analogue Scale (VAS)
Periodo de tiempo: estimately every 2.8 days from baseline to 4 weeks later, and 4 weeks later from the end of treatment
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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'
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estimately every 2.8 days from baseline to 4 weeks later, and 4 weeks later from the end of treatment
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Change from baseline in Korean Oswestry disability index (KODI)
Periodo de tiempo: at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
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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.
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at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
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Change from baseline in Korean Roland Morris Disability Questionnaire (KRMDQ)
Periodo de tiempo: at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
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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.
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at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
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Change from baseline in Traditional Medicine Back pain Questionnaire (TMBQ)
Periodo de tiempo: at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
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TMBQ is checked by the patients.
TMBQ is a questionnaire to measure the back-related disability in aspect of oriental medicine.
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at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
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Change from baseline in Modified schöber test
Periodo de tiempo: at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
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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.
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at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
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Change from baseline in Finger-to-floor distance
Periodo de tiempo: at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
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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.
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at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
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Change from baseline in Finger-to-thigh distraction
Periodo de tiempo: at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
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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.
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at baseline, 2 weeks and 4 weeks later from baseline, and 4 weeks later from the end of treatment
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Adverse Events
Periodo de tiempo: estimately every 2.8 days from baseline to 4 weeks later, and 4 weeks later from the end of treatment
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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.
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estimately every 2.8 days from baseline to 4 weeks later, and 4 weeks later from the end of treatment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Seung Deok Lee, Ph.D., Donnguk University Oriental Medical center
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de septiembre de 2014
Finalización primaria (Anticipado)
1 de septiembre de 2015
Finalización del estudio (Anticipado)
1 de septiembre de 2015
Fechas de registro del estudio
Enviado por primera vez
14 de octubre de 2014
Primero enviado que cumplió con los criterios de control de calidad
9 de noviembre de 2014
Publicado por primera vez (Estimar)
13 de noviembre de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
13 de noviembre de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
9 de noviembre de 2014
Última verificación
1 de noviembre de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- OCH-S100-2014
- HI11C2135 (Otro número de subvención/financiamiento: The Korea Health Industry Development Institute)
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