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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doin (conduction exercise) | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale (NRS) of low back pain | 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'. | Baseline, 3, 7, 10, 14, 30, 90 days post-baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Herniated lumbar disc (HLD) patients with radiating leg pain
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| Name | Affiliation | Role |
|---|---|---|
| Min-young Kim, KMD | Daejeon Jaseng Hospital of Korean Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daejeon Jaseng Hospital of Korean Medicine | Daejeon | 35262 | South Korea |
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| Herbal medicine | Drug | 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). |
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| Chuna manual therapy | Procedure | 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. |
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| Bee venom pharmacopuncture | Procedure | 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). |
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| Pharmacopuncture | Procedure | 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). |
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| Acupuncture | Procedure | Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points. |
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| Electroacupuncture | Procedure | Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points. |
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| Cupping | Procedure | Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points. |
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| Other intervention(s) | Other | 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. |
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| Numeric Rating Scale (NRS) of radiating leg pain | 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'. | Baseline, 3, 7, 10, 14, 30, 90 days post-baseline |
| Oswestry Disability Index (ODI) | 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. | Baseline, 3, 7, 10, 14, 30, 90 days post-baseline |
| Visual Analogue Scale (VAS) of radiating leg pain | 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. | Baseline, 3, 7, 10, 14 days post-baseline |
| Visual Analogue Scale (VAS) of low back pain | 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. | Baseline, 3, 7, 10, 14 days post-baseline |
| EuroQol 5-Dimension (EQ-5D) | 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. | Baseline, 3, 7, 10, 14, 30, 90 days post-baseline |
| Patient Global Impression of Change (PGIC) | 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). | Baseline, 14, 30, 90 days post-baseline |
| Drug Consumption (drug type) | Regarding recent use of medication, the type of prescription intake for medicine will be recorded. | Baseline, 3, 7, 10, 14, 30, 90 days post-baseline |
| Drug Consumption (drug intake frequency) | Regarding recent use of medication, the frequency of prescription intake for medicine will be recorded. | Baseline, 3, 7, 10, 14, 30, 90 days post-baseline |
| Drug Consumption (drug intake period) | Regarding recent use of medication, the period of prescription intake for medicine will be recorded. | Baseline, 3, 7, 10, 14, 30, 90 days post-baseline |
| Use of additional medical treatment (treatment type) | Regarding current use of medical services, the type of additional medical treatment received will be recorded. | Baseline, 3, 7, 10, 14, 30, 90 days post-baseline |
| Use of additional medical treatment (treatment frequency) | Regarding current use of medical services, the frequency of additional medical treatment received will be recorded. | Baseline, 3, 7, 10, 14, 30, 90 days post-baseline |
| Use of additional medical treatment (treatment period) | Regarding current use of medical services, the period of additional medical treatment received will be recorded. | Baseline, 3, 7, 10, 14, 30, 90 days post-baseline |
| Details of Doin conduction exercise sessions (type (region)) | Administration details of Doin conduction exercise session type (region) will be recorded. | Baseline, 3, 7, 10, 14, 30, 90 days post-baseline |
| Details of Doin conduction exercise sessions (period) | Administration details of Doin conduction exercise sessions (period) will be recorded. | Baseline, 3, 7, 10, 14, 30, 90 days post-baseline |
| Lumbar range of movement (ROM) | Physical examination | Baseline, 3, 7, 10, 14 days post-baseline |
| Straight leg raise (SLR) test | Physical examination | Baseline, 3, 7, 10, 14 days post-baseline |
| Adverse events | Safety outcome | Baseline, 3, 7, 10, 14, 30, 90 days post-baseline |
| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| D012585 | Sciatica |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020426 | Sciatic Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009437 | Neuralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D008517 | Phytotherapy |
| D015670 | Acupuncture Therapy |
| D015671 | Electroacupuncture |
| D000079742 | Cupping Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D003131 | Combined Modality Therapy |
| D004599 | Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |
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