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

9 de novembro de 2014 atualizado 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).

Visão geral do estudo

Status

Desconhecido

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Antecipado)

80

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Republica da Coréia
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Republica da Coréia, 463-865
        • Recrutamento
        • Donnguk University Oriental Medical Hospital
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

20 anos a 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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℃.
Dispositivo: 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.
Outros nomes:
  • OCH-S100
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.
Dispositivo: 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.
Outros nomes:
  • OCH-S100

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change from baseline in 100mm Pain Visual Analogue Scale (VAS)
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change from baseline in 100mm Pain Visual Analogue Scale (VAS)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Eun Jung Kim

Colaboradores

Ministry of Health & Welfare, Korea

Investigadores

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

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de setembro de 2014

Conclusão Primária (Antecipado)

1 de setembro de 2015

Conclusão do estudo (Antecipado)

1 de setembro de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

14 de outubro de 2014

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de novembro de 2014

Primeira postagem (Estimativa)

13 de novembro de 2014

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

13 de novembro de 2014

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de novembro de 2014

Última verificação

1 de novembro de 2014

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • OCH-S100-2014
  • HI11C2135 (Número de outro subsídio/financiamento: The Korea Health Industry Development Institute)

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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