The Effectiveness of Doin (Conduction Exercise) of the Pelvic Joint for HLD With Radiating Leg Pain

Completed

• Conditions: Intervertebral Disc Displacement; Sciatica; Sciatic Radiculopathy
• Interventions: Drug: Herbal medicine; Procedure: Doin (conduction exercise); Procedure: Chuna manual therapy; Procedure: Bee venom pharmacopuncture; Procedure: Pharmacopuncture; Procedure: Acupuncture; Procedure: Electroacupuncture; Procedure: Cupping; Other: Other intervention(s)

• Registration Number: NCT03571503
• Lead Sponsor: Jaseng Medical Foundation

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.

Study Timeline

• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-06-18
• Study First Posted: 2018-06-27
• Study Start: 2018-07-09
• Primary Completion: 2019-07-04
• Study Completion: 2019-09-20
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-01
• Last Update Posted: 2019-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Integrative Korean medicine treatment	Bee venom pharmacopuncture	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.
Integrative Korean medicine treatment	Herbal medicine	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.
Integrative Korean medicine treatment	Chuna manual therapy	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.
Integrative Korean medicine treatment	Acupuncture	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.
Integrative Korean medicine treatment	Electroacupuncture	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.
Integrative Korean medicine treatment	Cupping	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.
Integrative Korean medicine treatment	Other intervention(s)	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.
Doin with integrative Korean medicine	Doin (conduction exercise)	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.
Doin with integrative Korean medicine	Cupping	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.
Integrative Korean medicine treatment	Pharmacopuncture	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.
Doin with integrative Korean medicine	Herbal 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.
Doin with integrative Korean medicine	Chuna manual therapy	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.
Doin with integrative Korean medicine	Bee venom pharmacopuncture	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.
Doin with integrative Korean medicine	Pharmacopuncture	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.
Doin with integrative Korean medicine	Acupuncture	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.
Doin with integrative Korean medicine	Electroacupuncture	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.
Doin with integrative Korean medicine	Other intervention(s)	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.

Primary Outcome Measures

Name	Time	Method
Change in Numeric Rating Scale (NRS) of low back pain	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)	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	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'.

Secondary Outcome Measures

Name	Time	Method
Numeric Rating Scale (NRS) of low back pain	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline	Low back pain intensity 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'.
Use of additional medical treatment (treatment type)	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline	Regarding current use of medical services, the type of additional medical treatment received will be recorded.
Use of additional medical treatment (treatment frequency)	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline	Regarding current use of medical services, the frequency of additional medical treatment received will be recorded.
Numeric Rating Scale (NRS) of radiating leg pain	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline	Radiating leg pain intensity 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'.
Oswestry Disability Index (ODI)	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline	Functional disability questionnaire 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.
Visual Analogue Scale (VAS) of low back pain	Baseline, 3, 7, 10, 14 days post-baseline	Low back pain intensity as measured using VAS. 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' and 'worst pain possible' (labels may vary by study). Scores are recorded in millimeters with a total range of 0-100 millimeters.
Visual Analogue Scale (VAS) of radiating leg pain	Baseline, 3, 7, 10, 14 days post-baseline	Radiating leg pain intensity as measured using VAS. 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' and 'worst pain possible' (labels may vary by study). Scores are recorded in millimeters with a total range of 0-100 millimeters.
Drug Consumption (drug intake frequency)	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline	Regarding recent use of medication, the frequency of prescription intake for medicine will be recorded.
Drug Consumption (drug intake period)	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline	Regarding recent use of medication, the period of prescription intake for medicine will be recorded.
EuroQol 5-Dimension (EQ-5D)	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline	Health-related quality of life questionnaire as measured using 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.
Patient Global Impression of Change (PGIC)	Baseline, 14, 30, 90 days post-baseline	Global patient-reported outcome as measured using 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).
Drug Consumption (drug type)	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline	Regarding recent use of medication, the type of prescription intake for medicine will be recorded.
Use of additional medical treatment (treatment period)	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline	Regarding current use of medical services, the period of additional medical treatment received will be recorded.
Details of Doin conduction exercise sessions (type (region))	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline	Administration details of Doin conduction exercise session type (region) will be recorded.
Details of Doin conduction exercise sessions (period)	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline	Administration details of Doin conduction exercise sessions (period) will be recorded.
Lumbar range of movement (ROM)	Baseline, 3, 7, 10, 14 days post-baseline	Physical examination
Straight leg raise (SLR) test	Baseline, 3, 7, 10, 14 days post-baseline	Physical examination
Adverse events	Baseline, 3, 7, 10, 14, 30, 90 days post-baseline	Safety outcome

Trial Locations

Locations (1)

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