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

NCT03426215 | Completed

• 1 other identifier: JS-CT-2017-13
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain; Sciatica; Intervertebral Disc Displacement

Outcome Measures

Primary Outcomes (1)

• Change in Visual Analogue Scale (VAS) of radiating leg pain

  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 Outcomes (12)

• Visual Analogue Scale (VAS) of low back pain

  Baseline, and 10 years

• Visual Analogue Scale (VAS) of radiating leg pain

  Baseline, and 10 years

• Numeric Rating Scale (NRS) of low back pain

  Baseline, and 10 years

• Numeric Rating Scale (NRS) of radiating leg pain

  Baseline, and 10 years

• Oswestry Disability Index (ODI)

  Baseline, 10 years

Study Arms (1)

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)

Interventions

Magnetic Resonance Imaging (MRI) 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.

Ten year follow-up group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Jaseng Hospital of Korean Medicine

Seoul, 06110, South Korea

Location

MeSH Terms

Conditions

Low Back Pain; Sciatica; Intervertebral Disc Displacement

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Me-riong Kim, KMD, M.Sc.

  Jaseng Medical Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 8, 2018
• Study Start: March 10, 2018
• Primary Completion: April 28, 2018
• Study Completion: April 28, 2018
• Last Updated: June 4, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)