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| Name | Class |
|---|---|
| National Research Foundation of Korea | OTHER |
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This research is planned to build a basis about the efficacy and mechanism of acupuncture on pain and emotional disorder in patients with chronic sciatica using fMRI.
Clinical research to assess the effect of acupuncture for chronic sciatica on pain and emotional disorder will be processed with randomized, patient-assessor blinding, and sham-acupuncture controlled study design. Sixty eight subjects would be collected and divided into two groups(experimental and placebo, 34 subjects each). Experimental group will undergo with real acupuncture treatment(manual acupuncture + electroacupuncture) and placebo group will undergo with sham acupuncture treatment (acupuncture without skin penetration + electroacupuncture without electrical stimulation) twice a week, for 4 weeks. The effect on parameters related with pain and emotional disorder will be assessed at 1(baseline: just before the beginning of treatment) and 5(primary end point: 1 week after the end of treatment) weeks. Functional magnetic resonance imaging will be also conducted for 52 subjects(experimental and placebo, 20 among 34 subjects each + normal control 12 subjects) at 1 and 5 weeks to seek machanism of acupuncture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real acupuncture | Experimental | manual acupuncture + electroacupuncuture on acupoints, twice a week, for 4 weeks |
|
| Sham acupuncture | Sham Comparator | sham acupuncture (no skin penetration) + placebo electroacupuncture without electrical stimulation on acupoints, twice a week, for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real acupuncture | Device | manual acupuncture(0.25mm diameter x 40mm length, stainless steel, Dongbangacupuncture Inc., Korea) (unilateral GB30) + electroacupuncture(0.25mm diameter x 40mm length, stainless steel, Dongbangacupuncture Inc., Korea) (unilateral EX-B2 (L4 & L5), BL25, BL23, BL40, GB34), twice a week, for 4 weeks, common approaches for the treatment of chronic sciatica used by doctors of Korean medicine in Korea today |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogue scale for bothersomeness | change in visual analoge scale for bothersomeness [range: 0(better)-100(worse) mm] | baseline, 1-1, 1-2, 2-1, 2-2, 3-1, 3-2, 4-1, 4-2, 5, and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogue scale for pain intensity | change in visual analogue scale for pain intensity [range: 0(better)-100(worse) mm] | baseline, 1-1, 1-2, 2-1, 2-2, 3-1, 3-2, 4-1, 4-2, 5, and 8 weeks |
| Oswestry Disability Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Koh-Woon Kim, Ph.D. | Contact | 82-2-440-7577 | garson83@hanmail.net |
| Name | Affiliation | Role |
|---|---|---|
| Mi-Yeon Song, Ph.D. | Department of Rehabilitation Medicine of Korean Medicine, Kyung Hee University Hospital at Gangdong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Hospital at Gangdong | Recruiting | Seoul | 05278 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30651139 | Derived | Kim KW, Park K, Park HJ, Jahng GH, Jo DJ, Cho JH, Song EM, Shin WC, Yoon YJ, Kim SJ, Eun S, Song MY. Effect and neurophysiological mechanism of acupuncture in patients with chronic sciatica: protocol for a randomized, patient-assessor blind, sham-controlled clinical trial. Trials. 2019 Jan 16;20(1):56. doi: 10.1186/s13063-018-3164-8. |
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| ID | Term |
|---|---|
| D012585 | Sciatica |
| ID | Term |
|---|---|
| D020426 | Sciatic Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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|
| Sham acupuncture | Device | sham acupuncture without skin penetration(0.25mm diameter x 40mm length, stainless steel, Acuprime, UK) (unilateral GB30) + placebo electroacupuncture (0.25mm diameter x 40mm length, stainless steel, Dongbangacupuncture Inc., Korea) without electrical stimulation (unilateral EX-B2, BL25, BL23, BL40, GB34), twice a week, for 4 weeks |
|
change in functional scale: Oswestry Disability Index [10 items, 0-5 points each, total 0(better) -50(worse) points]
| week 1(before treatment) and week 5(1 week after treatment, primary endpoint) |
| EuroQol 5-Dimension | change in quality of life scale: EuroQol 5-Dimension [5 items, 1-3 points each, total 5(better) -15(worse) points] | week 1(before treatment) and week 5(1 week after treatment, primary endpoint) |
| Coping Strategy Questionnaire | change in coping scale: Coping Strategy Questionnaire [8 subscales, total 48 items, 0-6 points each, divided into adaptive coping or disadaptive coping, not better or worse] | week 1(before treatment) and week 5(1 week after treatment, primary endpoint) |
| Beck Depression Inventory | change in emotion scale: Beck Depression Inventory [21 items, 1-4 points each, total 21(better) -84(worse) points] | week 1(before treatment) and week 5(1 week after treatment, primary endpoint) |
| State-Trait Anxiety Inventory | change in emotion scale: State-Trait Anxiety Inventory [40 items, 1-4 points each, divided into state anxiety or trait anxiety, not better or worse] | week 1(before treatment) and week 5(1 week after treatment, primary endpoint) |
| blood oxygenation level dependent in Magnetic Resonance Image, functional | change in blood oxygenation level dependent of steady state and event-related block design scan run in functional magnetic resonance image. cf. functional magnetic resonance image scan run design: REST(6 min)-TASK1(5 min)-3D T1(5 min)-TASK2(5 min)-DTI(6 min)-TASK3(6 min). REST: steady-state resting scan run. TASK1/2: event-related block design, emotion and pain stimulation model scan run. 2 distinct 5-min experiment blocks (each block-20(5*4) stimuli (6 sec, inter-stimulus interval: 9 sec); comprised of visual picture(International Affective Picture System: neutral, negative), pain(low back, hand), picture plus pain). 3D T1: structural image acquisition. DTI: diffusion tensor imaging. TASK3: steady state pain model scan run. Low back extension pain model. | week 1(before treatment) and week 5(1 week after treatment, primary endpoint) |
| Adverse events | number of participants with adverse events
| baseline, 1-1, 1-2, 2-1, 2-2, 3-1, 3-2, 4-1, 4-2, 5, and 8 weeks |
| D009422 | Nervous System Diseases |
| D009437 | Neuralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |