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

June 1, 2018 updated by: In-Hyuk Ha, KMD, Jaseng Medical Foundation

Observational Study on the Long-Term Course of Integrative Korean Medicine Treatment for Lumbar Intervertebral Disc Herniation: Prospective Multicenter 10 Year Follow-up

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Ten year follow-up group
No interventions will be administered (Magnetic Resonance Imaging (MRI) will be administered as an outcome measurement).
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Visual Analogue Scale (VAS) of radiating leg pain
Time Frame: Difference from baseline at 10 years
Visual Analogue Scale (VAS) uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain (minimum score: 0)' and 'worst pain imaginable (maximum score: 100)'. Total scores are recorded in millimeters with a total range of 0-100 millimeters. Higher VAS values represent more severe pain, and a greater change from baseline (If baseline - follow up is a positive value) indicates a better outcome.
Difference from baseline at 10 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS) of low back pain
Time Frame: Baseline, and 10 years
Visual Analogue Scale (VAS) uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain (minimum score: 0)' and 'worst pain imaginable (maximum score: 100)'. Total scores are recorded in millimeters with a total range of 0-100 millimeters. Higher VAS values represent more severe pain.
Baseline, and 10 years
Visual Analogue Scale (VAS) of radiating leg pain
Time Frame: Baseline, and 10 years
Visual Analogue Scale (VAS) uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain (minimum score: 0)' and 'worst pain imaginable (maximum score: 100)'. Total scores are recorded in millimeters with a total range of 0-100 millimeters. Higher VAS values represent more severe pain.
Baseline, and 10 years
Numeric Rating Scale (NRS) of low back pain
Time Frame: Baseline, and 10 years
In pain measurement using Numeric Rating Scale (NRS), patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.
Baseline, and 10 years
Numeric Rating Scale (NRS) of radiating leg pain
Time Frame: Baseline, and 10 years
In pain measurement using Numeric Rating Scale (NRS), patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 (minimum score) which indicates 'no pain', and 10 (maximum score) which indicates 'worst pain possible'. Higher NRS values represent more severe pain.
Baseline, and 10 years
Oswestry Disability Index (ODI)
Time Frame: Baseline, 10 years
The ODI is a 10-item questionnaire developed to assess level of disability due to low back pain (LBP). Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to LBP.
Baseline, 10 years
36-Item Short Form Survey (SF-36)
Time Frame: Baseline, 10 years
SF-36 consists of 36 items across 8 domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. SF-36 is used to rate functional health and well-being in patients and healthy individuals. Higher scores indicate better HRQoL.
Baseline, 10 years
Patient Global Impression of Change (PGIC)
Time Frame: Baseline, 10 years
PGIC grades the level of subjective improvement into 7 levels (1, very much improved; 2, much improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; and 7, very much worse).
Baseline, 10 years
Lumbar range of movement (ROM)
Time Frame: Baseline, 10 years
ROM measurements are valid (r=0.97) and reliable (r=0.94), but not highly responsive (effect size=0.1-0.6). If ROM is uncheckable from pain, the angle will be recorded as 0°.
Baseline, 10 years
Straight leg raise (SLR) test
Time Frame: Baseline, 10 years
While SLR measurements are reliable (intraclass correlation coefficient=0.95), they are not very responsive (effect size=0.2). If SLR is uncheckable from pain, the angle will be recorded as 0°.
Baseline, 10 years
Qualitative questionnaire on 10 year course
Time Frame: 10 years
The qualitative questionnaire on 10 year course and outcome since receiving integrative Korean medicine treatment used in this study is a 14-item descriptive evaluation encompassing various items (a mixture of short-answer questions, multiple choices, and transcript of essay form answers) on the change before and after treatment over the course of 10 years (e.g. change in perception of surgery and non-surgical treatment, change in everyday life or habits, and treatment recommendation to others).
10 years
Medical history
Time Frame: 10 years
Physicians will rate the causal relationship of each treatment from the previous clinical study with the patient's medical history potentially associated with treatment on a 6-point scale (1, definitely related; 2, probably related; 3, possibly related; 4, probably not related; 5, definitely not related; and 6, unknown), and classify all medical history potentially associated with treatment with the Spilker classification, which has 3 grades (1, mild: no intervention needed and does not greatly impede normal activity (function) of patient; 2, moderate: significantly impedes normal activity (function) of patient, and may need intervention, with subsequent resolution; 3, severe: severe adverse event needing intensive intervention, leaving sequela).
10 years
Adverse events
Time Frame: 10 years
Adverse events potentially associated with MRI will be assessed.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jaseng Medical Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Me-riong Kim, KMD, M.Sc., Jaseng Medical Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 28, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 28, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JS-CT-2017-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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