Clinical trial NCT03571503: The Effectiveness of Doin (Conduction Exercise) of the Pelvic Joint for HLD With Radiating Leg Pain
Official title: The Effectiveness of Doin (Conduction Exercise) of the Pelvic Joint for Herniated Lumbar Disc (HLD) With Radiating Leg Pain: A Prospective Observational Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intervertebral Disc Displacement
Sciatica
Sciatic Radiculopathy
Keywords: Complementary Therapies
Exercise
Acupuncture
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Herniated lumbar disc (HLD) patients with radiating leg pain

Brief summary: A prospective pilot study will be conducted to investigate the effectiveness and safety in herniated lumbar disc (HLD) patients receiving integrative Korean medicine treatment including Doin (conduction exercise) at a Korean medicine hospital through assessment of pain, functional disability, and quality of life.

Detailed description: A prospective single-center observational pilot study will be conducted to investigate the effectiveness and safety in herniated lumbar disc (HLD) patients with radiating leg pain receiving integrative Korean medicine treatment including Doin (conduction exercise) of the pelvic joint at Daejeon Jaseng Hospital of Korean Medicine through assessment of pain, functional disability, quality of life, satisfaction, and safety.

The study is expected to be performed over a period of 6 months, during the former 3 months of the study period of which the Integrative Korean medicine treatment group will be recruited, and after a wash-out period of 2 weeks, during the latter 3 months of the study period of which the Doin with integrative Korean medicine will be recruited separately.

Eligibility criteria: Inclusion Criteria:

* Inpatients with radiating leg pain distal to the gluteal fold with or without low back pain (LBP)
* Patients with onset of radiating leg pain occurrence within the last six months, and current pain intensity of numeric rating scale (NRS) ≥5
* Patients with disc protrusion or extrusion at the neural segment level with significant correlations with the radiating leg pain symptoms as identified on L-spine magnetic resonance imaging (MRI)
* Patients with plans of receiving Korean medicine treatment for herniated lumbar disc (HLD) through hospitalized care
* Patients who give voluntary written informed consent to study participation

Exclusion Criteria:

* Patients with other systemic diseases that may interfere with treatment effect or outcome interpretation
* Surgery and surgical procedure in the last three weeks in areas of clinical relevance as a result of HLD
* Patients with soft tissue pathologies or pathologies of non-spinal origin that may cause LBP or radiating leg pain (e.g. spinal tumor, rheumatoid arthritis)
* Patients for whom acupuncture treatment may be inappropriate or unsafe (e.g. hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine intake, serious diabetes with risk of infection, severe cardiovascular diseases, or other conditions deemed unsuitable for acupuncture treatment)
* Pregnant patients or patients planning pregnancy
* Patients with serious psychological disorders
* Participating in other clinical studies other than observational studies
* Patients unable to fill out study participation consent form
* Subjects deemed unsuitable for study participation as assessed by the researchers

Primary outcomes:
measure: Change in Numeric Rating Scale (NRS) of low back pain
timeFrame: Baseline, 2 weeks post-baseline
measure: Change in Numeric Rating Scale (NRS) of radiating leg pain
timeFrame: Baseline, 2 weeks post-baseline
measure: Change in Oswestry Disability Index (ODI)
timeFrame: Baseline, 2 weeks post-baseline
Secondary outcomes:
measure: Numeric Rating Scale (NRS) of low back pain
timeFrame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
measure: Numeric Rating Scale (NRS) of radiating leg pain
timeFrame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
measure: Oswestry Disability Index (ODI)
timeFrame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
measure: Visual Analogue Scale (VAS) of radiating leg pain
timeFrame: Baseline, 3, 7, 10, 14 days post-baseline
measure: Visual Analogue Scale (VAS) of low back pain
timeFrame: Baseline, 3, 7, 10, 14 days post-baseline
measure: EuroQol 5-Dimension (EQ-5D)
timeFrame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
measure: Patient Global Impression of Change (PGIC)
timeFrame: Baseline, 14, 30, 90 days post-baseline
measure: Drug Consumption (drug type)
timeFrame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
measure: Drug Consumption (drug intake frequency)
timeFrame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
measure: Drug Consumption (drug intake period)
timeFrame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
measure: Use of additional medical treatment (treatment type)
timeFrame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
measure: Use of additional medical treatment (treatment frequency)
timeFrame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
measure: Use of additional medical treatment (treatment period)
timeFrame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
measure: Details of Doin conduction exercise sessions (type (region))
timeFrame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
measure: Details of Doin conduction exercise sessions (period)
timeFrame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
measure: Lumbar range of movement (ROM)
timeFrame: Baseline, 3, 7, 10, 14 days post-baseline
measure: Straight leg raise (SLR) test
timeFrame: Baseline, 3, 7, 10, 14 days post-baseline
measure: Adverse events
timeFrame: Baseline, 3, 7, 10, 14, 30, 90 days post-baseline
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Daejeon Jaseng Hospital of Korean Medicine
Study officials:
affiliation: Daejeon Jaseng Hospital of Korean Medicine
name: Min-young Kim, KMD
role: PRINCIPAL_INVESTIGATOR
References: