The Effectiveness of Doin (Conduction Exercise) of the Pelvic Joint for Herniated Lumbar Disc (HLD) With Radiating Leg Pain: A Prospective Observational Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Numeric Rating Scale (NRS) of low back pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Integrative Korean medicine treatment
Herniated lumbar disc (HLD) patients with radiating leg pain in the integrative Korean medicine treatment group will be administered integrative Korean medicine treatment consisting of 2 sessions/day of acupuncture, and herbal medicine, Chuna manual therapy, bee venom pharmacopuncture and pharmacopuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Herbal medicine (Drug)
Integrative Korean medicine treatment
Herniated lumbar disc (HLD) patients with radiating leg pain in the integrative Korean medicine treatment group will be administered integrative Korean medicine treatment consisting of 2 sessions/day of acupuncture, and herbal medicine, Chuna manual therapy, bee venom pharmacopuncture and pharmacopuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Chuna manual therapy (Procedure)
Integrative Korean medicine treatment
Herniated lumbar disc (HLD) patients with radiating leg pain in the integrative Korean medicine treatment group will be administered integrative Korean medicine treatment consisting of 2 sessions/day of acupuncture, and herbal medicine, Chuna manual therapy, bee venom pharmacopuncture and pharmacopuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Bee venom pharmacopuncture (Procedure)
Integrative Korean medicine treatment
Herniated lumbar disc (HLD) patients with radiating leg pain in the integrative Korean medicine treatment group will be administered integrative Korean medicine treatment consisting of 2 sessions/day of acupuncture, and herbal medicine, Chuna manual therapy, bee venom pharmacopuncture and pharmacopuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Pharmacopuncture (Procedure)
Integrative Korean medicine treatment
Herniated lumbar disc (HLD) patients with radiating leg pain in the integrative Korean medicine treatment group will be administered integrative Korean medicine treatment consisting of 2 sessions/day of acupuncture, and herbal medicine, Chuna manual therapy, bee venom pharmacopuncture and pharmacopuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Acupuncture (Procedure)
Integrative Korean medicine treatment
Herniated lumbar disc (HLD) patients with radiating leg pain in the integrative Korean medicine treatment group will be administered integrative Korean medicine treatment consisting of 2 sessions/day of acupuncture, and herbal medicine, Chuna manual therapy, bee venom pharmacopuncture and pharmacopuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Electroacupuncture (Procedure)
Integrative Korean medicine treatment
Herniated lumbar disc (HLD) patients with radiating leg pain in the integrative Korean medicine treatment group will be administered integrative Korean medicine treatment consisting of 2 sessions/day of acupuncture, and herbal medicine, Chuna manual therapy, bee venom pharmacopuncture and pharmacopuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Cupping (Procedure)
Integrative Korean medicine treatment
Herniated lumbar disc (HLD) patients with radiating leg pain in the integrative Korean medicine treatment group will be administered integrative Korean medicine treatment consisting of 2 sessions/day of acupuncture, and herbal medicine, Chuna manual therapy, bee venom pharmacopuncture and pharmacopuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Other intervention(s) (Other)
Doin with integrative Korean medicine
Herniated lumbar disc (HLD) patients with radiating leg pain in the Doin (conduction exercise) with integrative Korean medicine treatment group will be administered integrative Korean medicine treatment consisting of 2 sessions/day of acupuncture, and herbal medicine, Chuna manual therapy, bee venom pharmacopuncture and pharmacopuncture, electroacupuncture, cupping, and other interventions, as needed, plus Doin (conduction exercise) for 1 session of the 2 sessions/day of acupuncture.
干预措施: Doin (conduction exercise) (Procedure)
Doin with integrative Korean medicine
Herniated lumbar disc (HLD) patients with radiating leg pain in the Doin (conduction exercise) with integrative Korean medicine treatment group will be administered integrative Korean medicine treatment consisting of 2 sessions/day of acupuncture, and herbal medicine, Chuna manual therapy, bee venom pharmacopuncture and pharmacopuncture, electroacupuncture, cupping, and other interventions, as needed, plus Doin (conduction exercise) for 1 session of the 2 sessions/day of acupuncture.
干预措施: Herbal medicine (Drug)
Doin with integrative Korean medicine
Herniated lumbar disc (HLD) patients with radiating leg pain in the Doin (conduction exercise) with integrative Korean medicine treatment group will be administered integrative Korean medicine treatment consisting of 2 sessions/day of acupuncture, and herbal medicine, Chuna manual therapy, bee venom pharmacopuncture and pharmacopuncture, electroacupuncture, cupping, and other interventions, as needed, plus Doin (conduction exercise) for 1 session of the 2 sessions/day of acupuncture.
干预措施: Chuna manual therapy (Procedure)
Doin with integrative Korean medicine
Herniated lumbar disc (HLD) patients with radiating leg pain in the Doin (conduction exercise) with integrative Korean medicine treatment group will be administered integrative Korean medicine treatment consisting of 2 sessions/day of acupuncture, and herbal medicine, Chuna manual therapy, bee venom pharmacopuncture and pharmacopuncture, electroacupuncture, cupping, and other interventions, as needed, plus Doin (conduction exercise) for 1 session of the 2 sessions/day of acupuncture.
干预措施: Bee venom pharmacopuncture (Procedure)
Doin with integrative Korean medicine
Herniated lumbar disc (HLD) patients with radiating leg pain in the Doin (conduction exercise) with integrative Korean medicine treatment group will be administered integrative Korean medicine treatment consisting of 2 sessions/day of acupuncture, and herbal medicine, Chuna manual therapy, bee venom pharmacopuncture and pharmacopuncture, electroacupuncture, cupping, and other interventions, as needed, plus Doin (conduction exercise) for 1 session of the 2 sessions/day of acupuncture.
干预措施: Pharmacopuncture (Procedure)
Doin with integrative Korean medicine
Herniated lumbar disc (HLD) patients with radiating leg pain in the Doin (conduction exercise) with integrative Korean medicine treatment group will be administered integrative Korean medicine treatment consisting of 2 sessions/day of acupuncture, and herbal medicine, Chuna manual therapy, bee venom pharmacopuncture and pharmacopuncture, electroacupuncture, cupping, and other interventions, as needed, plus Doin (conduction exercise) for 1 session of the 2 sessions/day of acupuncture.
干预措施: Acupuncture (Procedure)
Doin with integrative Korean medicine
Herniated lumbar disc (HLD) patients with radiating leg pain in the Doin (conduction exercise) with integrative Korean medicine treatment group will be administered integrative Korean medicine treatment consisting of 2 sessions/day of acupuncture, and herbal medicine, Chuna manual therapy, bee venom pharmacopuncture and pharmacopuncture, electroacupuncture, cupping, and other interventions, as needed, plus Doin (conduction exercise) for 1 session of the 2 sessions/day of acupuncture.
干预措施: Electroacupuncture (Procedure)
Doin with integrative Korean medicine
Herniated lumbar disc (HLD) patients with radiating leg pain in the Doin (conduction exercise) with integrative Korean medicine treatment group will be administered integrative Korean medicine treatment consisting of 2 sessions/day of acupuncture, and herbal medicine, Chuna manual therapy, bee venom pharmacopuncture and pharmacopuncture, electroacupuncture, cupping, and other interventions, as needed, plus Doin (conduction exercise) for 1 session of the 2 sessions/day of acupuncture.
干预措施: Cupping (Procedure)
Doin with integrative Korean medicine
Herniated lumbar disc (HLD) patients with radiating leg pain in the Doin (conduction exercise) with integrative Korean medicine treatment group will be administered integrative Korean medicine treatment consisting of 2 sessions/day of acupuncture, and herbal medicine, Chuna manual therapy, bee venom pharmacopuncture and pharmacopuncture, electroacupuncture, cupping, and other interventions, as needed, plus Doin (conduction exercise) for 1 session of the 2 sessions/day of acupuncture.
干预措施: Other intervention(s) (Other)
结局指标
主要结局
Change in Numeric Rating Scale (NRS) of low back pain
时间窗: Baseline, 2 weeks post-baseline
Change in low back pain intensity at 2 weeks as measured using NRS. In pain measurement using 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'.
Change in Oswestry Disability Index (ODI)
时间窗: Baseline, 2 weeks post-baseline
Functional disability questionnaire at 2 weeks as measured using 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.
Change in Numeric Rating Scale (NRS) of radiating leg pain
时间窗: Baseline, 2 weeks post-baseline
Change in radiating leg pain intensity at 2 weeks as measured using NRS. In pain measurement using 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'.
次要结局
- Numeric Rating Scale (NRS) of low back pain(Baseline, 3, 7, 10, 14, 30, 90 days post-baseline)
- Use of additional medical treatment (treatment type)(Baseline, 3, 7, 10, 14, 30, 90 days post-baseline)
- Use of additional medical treatment (treatment frequency)(Baseline, 3, 7, 10, 14, 30, 90 days post-baseline)
- Numeric Rating Scale (NRS) of radiating leg pain(Baseline, 3, 7, 10, 14, 30, 90 days post-baseline)
- Oswestry Disability Index (ODI)(Baseline, 3, 7, 10, 14, 30, 90 days post-baseline)
- Visual Analogue Scale (VAS) of low back pain(Baseline, 3, 7, 10, 14 days post-baseline)
- Visual Analogue Scale (VAS) of radiating leg pain(Baseline, 3, 7, 10, 14 days post-baseline)
- Drug Consumption (drug intake frequency)(Baseline, 3, 7, 10, 14, 30, 90 days post-baseline)
- Drug Consumption (drug intake period)(Baseline, 3, 7, 10, 14, 30, 90 days post-baseline)
- EuroQol 5-Dimension (EQ-5D)(Baseline, 3, 7, 10, 14, 30, 90 days post-baseline)
- Patient Global Impression of Change (PGIC)(Baseline, 14, 30, 90 days post-baseline)
- Drug Consumption (drug type)(Baseline, 3, 7, 10, 14, 30, 90 days post-baseline)
- Use of additional medical treatment (treatment period)(Baseline, 3, 7, 10, 14, 30, 90 days post-baseline)
- Details of Doin conduction exercise sessions (type (region))(Baseline, 3, 7, 10, 14, 30, 90 days post-baseline)
- Details of Doin conduction exercise sessions (period)(Baseline, 3, 7, 10, 14, 30, 90 days post-baseline)
- Lumbar range of movement (ROM)(Baseline, 3, 7, 10, 14 days post-baseline)
- Straight leg raise (SLR) test(Baseline, 3, 7, 10, 14 days post-baseline)
- Adverse events(Baseline, 3, 7, 10, 14, 30, 90 days post-baseline)
研究者
KIMMINYOUNG
Clinical Researcher
Jaseng Medical Foundation