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临床试验/NCT02841163
NCT02841163已完成不适用

Evaluation of Disc Resorption in Lumbar and Cervical Intervertebral Disc Herniation Patients Receiving Integrative Korean Medicine Treatment

Jaseng Medical Foundation1 个研究点 分布在 1 个国家目标入组 505 人开始时间: 2016年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
505
试验地点
1
主要终点
Area of disc herniation at disc level most relevant to patient symptoms on MR sagittal and axial view

研究概览

简要总结

Measurement of herniated disc resorption and assessment of satisfaction regarding post-treatment state and integrative Korean medicine treatment through phone interview in 500 patients with MRI follow-up results receiving treatment for lumbar and cervical disc herniation at Jaseng Hospital of Korean Medicine.

详细描述

Intervertebral disc herniation treatment can be largely divided into conservative and surgical approaches, and the greater majority of patients show relief of symptoms and resorption of herniated disc through non-surgical, conservative management. Despite concerns that early surgical interventions in intervertebral disc herniation without allowing for sufficient conservative treatment may indicate overtreatment, awareness and understanding in the general public is found somewhat lacking.

The objective of this study is to measure herniated disc resorption and assess satisfaction regarding post-treatment state and integrative Korean medicine treatment through phone interview in 500 patients with MRI follow-up results before and after receiving conservative treatment for lumbar and cervical disc herniation at Jaseng Hospital of Korean Medicine.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Lumbar and/or cervical disc herniation patients with baseline MRI and follow-up results after receiving treatment at Jaseng Hospital of Korean Medicine visiting between February 2012 and December
  • Participants giving informed written consent to use of medical records for academic means.

排除标准

  • Participants refusing to participate in study or to respond to phone interview.

研究组 & 干预措施

Lumbar/cervical disc herniation group

Lumbar and cervical intervertebral disc herniation patients are administered integrative Korean medicine treatment consisting of herbal medicine, acupuncture, pharmacopuncture, bee venom pharmacopuncture, and Chuna manipulation.

干预措施: Herbal medicine (Drug)

Lumbar/cervical disc herniation group

Lumbar and cervical intervertebral disc herniation patients are administered integrative Korean medicine treatment consisting of herbal medicine, acupuncture, pharmacopuncture, bee venom pharmacopuncture, and Chuna manipulation.

干预措施: Acupuncture (Procedure)

Lumbar/cervical disc herniation group

Lumbar and cervical intervertebral disc herniation patients are administered integrative Korean medicine treatment consisting of herbal medicine, acupuncture, pharmacopuncture, bee venom pharmacopuncture, and Chuna manipulation.

干预措施: Pharmacopuncture (Procedure)

Lumbar/cervical disc herniation group

Lumbar and cervical intervertebral disc herniation patients are administered integrative Korean medicine treatment consisting of herbal medicine, acupuncture, pharmacopuncture, bee venom pharmacopuncture, and Chuna manipulation.

干预措施: Bee venom pharmacopuncture (Procedure)

Lumbar/cervical disc herniation group

Lumbar and cervical intervertebral disc herniation patients are administered integrative Korean medicine treatment consisting of herbal medicine, acupuncture, pharmacopuncture, bee venom pharmacopuncture, and Chuna manipulation.

干预措施: Chuna manipulation (Procedure)

结局指标

主要结局

Area of disc herniation at disc level most relevant to patient symptoms on MR sagittal and axial view

时间窗: Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months

Comparison of disc herniation in MRI between the baseline and post-treatment.

次要结局

  • Level of disc degeneration at disc level most relevant to patient symptoms on MR sagittal and axial view(Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months)
  • Level of disc herniation at disc level most relevant to patient symptoms on MR sagittal and axial view(Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months)
  • Level of herniated disc migration in patients with disc migration at disc level most relevant to patient symptoms on MR sagittal and axial view(Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months)
  • Modic type change at vertebrae adjacent to disc level most relevant to patient symptoms on MR sagittal and axial view(Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months)
  • Modic type change location with regard to disc level most relevant to patient symptoms on MR sagittal and axial view(Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months)
  • Pain NRS at site of chief complaint(Change from baseline MRI (taken before treatment) at post-treatment follow-up phone interview at average of 3 years)
  • Radiating pain NRS associated with site of chief complaint(Change from baseline MRI (taken before treatment) at post-treatment follow-up phone interview at average of 3 years)
  • Whether or not patient has been recommended for surgery regarding pain at site of chief complaint(Post-treatment follow-up phone interview at average of 3 years)
  • Whether or not pain has recurred for 1 month or longer at site of chief complaint(Post-treatment follow-up phone interview at average of 3 years)
  • Type of treatment received, if any, for pain recurrence for 1 month or longer at site of chief complaint(Post-treatment follow-up phone interview at average of 3 years)
  • Whether or not patient was aware of possible spontaneous disc resorption at site of chief complaint at onset(Post-treatment follow-up phone interview at average of 3 years)
  • Type of treatment patient would recommend to others as primary care(Post-treatment follow-up phone interview at average of 3 years)
  • Satisfaction with integrative Korean medicine treatment(Post-treatment follow-up phone interview at average of 3 years)
  • Korean medicine treatment method perceived to be most effective(Post-treatment follow-up phone interview at average of 3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

In-Hyuk Ha, KMD

Director

Jaseng Medical Foundation

研究点 (1)

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