Clinical trial NCT03426215: Long-Term Course of Korean Medicine Treatment for Lumbar Disc Herniation
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Sciatica
Intervertebral Disc Displacement
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 65
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Visual Analogue Scale (VAS) of radiating leg pain
timeFrame: Difference from baseline at 10 years
Secondary outcomes:
measure: Visual Analogue Scale (VAS) of low back pain
timeFrame: Baseline, and 10 years
measure: Visual Analogue Scale (VAS) of radiating leg pain
timeFrame: Baseline, and 10 years
measure: Numeric Rating Scale (NRS) of low back pain
timeFrame: Baseline, and 10 years
measure: Numeric Rating Scale (NRS) of radiating leg pain
timeFrame: Baseline, and 10 years
measure: Oswestry Disability Index (ODI)
timeFrame: Baseline, 10 years
measure: 36-Item Short Form Survey (SF-36)
timeFrame: Baseline, 10 years
measure: Patient Global Impression of Change (PGIC)
timeFrame: Baseline, 10 years
measure: Lumbar range of movement (ROM)
timeFrame: Baseline, 10 years
measure: Straight leg raise (SLR) test
timeFrame: Baseline, 10 years
measure: Qualitative questionnaire on 10 year course
timeFrame: 10 years
measure: Medical history
timeFrame: 10 years
measure: Adverse events
timeFrame: 10 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
Study officials:
affiliation: Jaseng Medical Foundation
name: Me-riong Kim, KMD, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: