Long-Term Course of Korean Medicine Treatment for Lumbar Disc Herniation

NCT ID: NCT03426215

Last Updated: 2018-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-10

Study Completion Date

2018-04-28

Brief Summary

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This observational study will assess the long-term course and effect of Korean medicine treatment in lumbar intervertebral disc herniation patients who received integrative Korean medicine treatment for 24 weeks as part of a previous clinical study.

Detailed Description

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This observational study will assess the long-term course and effect of Korean medicine treatment in lumbar intervertebral disc herniation patients with a main complaint of radiating leg pain who received integrative Korean medicine treatment for 24 weeks at Jaseng Hospital of Korean Medicine (Gangnam main branch) as part of a previous clinical study which was conducted from November, 2006 to April, 2007, and give written informed consent to long-term follow-up assessment at 10 years.

Conditions

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Low Back Pain Sciatica Intervertebral Disc Displacement

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Ten year follow-up group

No interventions will be administered (Magnetic Resonance Imaging (MRI) will be administered as an outcome measurement).

Magnetic Resonance Imaging (MRI)

Intervention Type DIAGNOSTIC_TEST

Changes in size and severity of the main herniated disc causing radiating pain will be evaluated by radiology specialists and Korean medicine doctors (KMDs) and categorized into three groups (improved, worse or no discernible change) in comparison with the immediate previous MRI to track long-term changes and assess for correlations in subjective clinical symptoms and objective physical evaluation and MRI results.

Interventions

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Magnetic Resonance Imaging (MRI)

Changes in size and severity of the main herniated disc causing radiating pain will be evaluated by radiology specialists and Korean medicine doctors (KMDs) and categorized into three groups (improved, worse or no discernible change) in comparison with the immediate previous MRI to track long-term changes and assess for correlations in subjective clinical symptoms and objective physical evaluation and MRI results.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Lumbar intervertebral disc herniation patients with a main complaint of radiating leg pain who received integrative Korean medicine treatment for 24 weeks at Jaseng Hospital of Korean Medicine (Gangnam main branch) as part of a previous clinical study which was conducted from November, 2006 to April, 2007
* Patients who give voluntary written informed consent to long-term follow-up assessment (quantitative and qualitative questionnaires, and MRI) at 10 years.

Exclusion Criteria

* Patients who cannot give voluntary written informed consent to this study or answer study questionnaires (e.g. severe psychological disorders)
* Patients participating in other clinical studies or otherwise deemed unsuitable by the researchers
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jaseng Medical Foundation

OTHER

Sponsor Role lead

Responsible Party

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In-Hyuk Ha, KMD

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Me-riong Kim, KMD, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Jaseng Medical Foundation

Locations

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Jaseng Hospital of Korean Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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JS-CT-2017-13

Identifier Type: -

Identifier Source: org_study_id

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