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

Completed

• Conditions: Sciatica; Low Back Pain; Intervertebral Disc Displacement
• Interventions: Diagnostic Test: Magnetic Resonance Imaging (MRI)

• Registration Number: NCT03426215
• Lead Sponsor: Jaseng Medical Foundation

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.

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 Timeline

• Study First Submitted: 2018-02-01
• Study First Submitted QC: 2018-02-07
• Study First Posted: 2018-02-08
• Study Start: 2018-03-10
• Primary Completion: 2018-04-28
• Study Completion: 2018-04-28
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-01
• Last Update Posted: 2018-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ten year follow-up group	Magnetic Resonance Imaging (MRI)	No interventions will be administered (Magnetic Resonance Imaging (MRI) will be administered as an outcome measurement).

Primary Outcome Measures

Name	Time	Method
Change in Visual Analogue Scale (VAS) of radiating leg pain	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.

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS) of radiating leg pain	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.
Lumbar range of movement (ROM)	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°.
Straight leg raise (SLR) test	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°.
Adverse events	10 years	Adverse events potentially associated with MRI will be assessed.
Oswestry Disability Index (ODI)	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.
Medical history	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).
Numeric Rating Scale (NRS) of radiating leg pain	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.
Patient Global Impression of Change (PGIC)	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).
Visual Analogue Scale (VAS) of low back pain	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.
Numeric Rating Scale (NRS) of low back pain	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'.
36-Item Short Form Survey (SF-36)	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.
Qualitative questionnaire on 10 year course	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).

Trial Locations

Locations (1)

Jaseng Hospital of Korean Medicine; 🇰🇷 Seoul, Korea, Republic of