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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03426215
• Other study ID #: JS-CT-2017-13
• Status: Completed
• Start date: March 10, 2018
• Est. completion date: April 28, 2018

Study information

• Verified date: June 2018
• Source: Jaseng Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 28, 2018
• Est. primary completion date: April 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Intervertebral Disc Displacement
• Low Back Pain
• Sciatica

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Jaseng Hospital of Korean Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Jaseng Medical Foundation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual Analogue Scale (VAS) of low back 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.	Baseline, and 10 years
Secondary	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.	Baseline, and 10 years
Secondary	Numeric Rating Scale (NRS) of low back pain	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
Secondary	Numeric Rating Scale (NRS) of radiating leg pain	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
Secondary	Oswestry Disability Index (ODI)	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
Secondary	36-Item Short Form Survey (SF-36)	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
Secondary	Patient Global Impression of Change (PGIC)	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
Secondary	Lumbar range of movement (ROM)	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
Secondary	Straight leg raise (SLR) test	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
Secondary	Qualitative questionnaire on 10 year course	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
Secondary	Medical history	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
Secondary	Adverse events	Adverse events potentially associated with MRI will be assessed.	10 years