The Effectiveness of Doin (Conduction Exercise) of the Pelvic Joint for HLD With Radiating Leg Pain
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2018
CompletedFirst Posted
Study publicly available on registry
June 27, 2018
CompletedStudy Start
First participant enrolled
July 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2019
CompletedNovember 4, 2019
November 1, 2019
12 months
June 1, 2018
November 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Numeric Rating Scale (NRS) of low back pain
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'.
Baseline, 2 weeks post-baseline
Change in Numeric Rating Scale (NRS) of radiating leg pain
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'.
Baseline, 2 weeks post-baseline
Change in Oswestry Disability Index (ODI)
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.
Baseline, 2 weeks post-baseline
Secondary Outcomes (18)
Numeric Rating Scale (NRS) of low back pain
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 radiating leg pain
Baseline, 3, 7, 10, 14 days post-baseline
Visual Analogue Scale (VAS) of low back pain
Baseline, 3, 7, 10, 14 days post-baseline
- +13 more secondary outcomes
Study Arms (2)
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.
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.
Interventions
An acupuncture physician will administer acupuncture at 4-8 acupoints in the low back and gluteal area (mandatory points: BL54, and GB30 ipsilateral to the dysfunctional site; and selective points: BL23, BL24, BL25, BL26, BL31, BL32, Ah-shi points, local acupuncture points and/or trigger points. Doin (conduction exercise) will be performed as active and passive movement with the needles in situ to the aim of effective treatment of pain and functional disability by increasing the hip joint range of motion (flexion and extension) with physician guidance and isometric resistance exercise (flexion and extension) as needed. Doin (conduction exercise) sessions will be performed 1 session/day for the duration of hospitalized treatment while the patient presents radiating leg pain (NRS≥1).
Herbal medicine will be mainly administered in water-based decoction (120ml) and dried powder (2g) form (the ingredients are mainly, but not restricted to: Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, Atractylodes japonica).
Chuna is a Korean spinal manipulation that incorporates spinal manipulation techniques for joint mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement. Chuna manipulation will be administered at the physician's discretion.
Bee venom pharmacopuncture will be administered only after confirming a negative response to hypersensitivity skin test. Diluted bee venom (saline:bee venom ratio, 10,000:1) filtered for allergens will be injected at 4-5 acupoints proximal to the dysfunctional site at the physician's discretion. Each acupuncture point will be injected to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
Pharmacopuncture consisting of select herbal ingredients will be administered at Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
Patients will be allowed any other additional intervention(s) as deemed necessary by the attending physician regardless of type or dose, and patterns of use will be investigated and recorded as an pragmatic clinical study.
Eligibility Criteria
Herniated lumbar disc (HLD) patients with radiating leg pain
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Daejeon Jaseng Hospital of Korean Medicine
Daejeon, 35262, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Min-young Kim, KMD
Daejeon Jaseng Hospital of Korean Medicine
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Researcher
Study Record Dates
First Submitted
June 1, 2018
First Posted
June 27, 2018
Study Start
July 9, 2018
Primary Completion
July 4, 2019
Study Completion
September 20, 2019
Last Updated
November 4, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share