An interventional study of Real acupuncture and Sham acupuncture in Chronic Sciatica, sponsored by Kyung Hee University Hospital at Gangdong. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-19.
Sponsored by Kyung Hee University Hospital at Gangdong · Not applicable, Interventional, and Treatment
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.
149 studies on the registry are indexed under Sciatica; 31 are open to participants now.
This study's planned enrollment of 68 is close to the median of 68 across 122 interventional studies indexed under Sciatica.
Browse Sciatica studies →Kyung Hee University Hospital at Gangdong is the lead sponsor of 23 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
manual acupuncture + electroacupuncuture on acupoints, twice a week, for 4 weeks
Device: Real acupuncture
sham acupuncture (no skin penetration) + placebo electroacupuncture without electrical stimulation on acupoints, twice a week, for 4 weeks
Device: Sham acupuncture
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
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
Visual analogue scale for bothersomeness
change in visual analoge scale for bothersomeness \[range: 0(better)-100(worse) mm\]
Time frame: baseline, 1-1, 1-2, 2-1, 2-2, 3-1, 3-2, 4-1, 4-2, 5, and 8 weeks
Visual analogue scale for pain intensity
change in visual analogue scale for pain intensity \[range: 0(better)-100(worse) mm\]
Time frame: baseline, 1-1, 1-2, 2-1, 2-2, 3-1, 3-2, 4-1, 4-2, 5, and 8 weeks
Oswestry Disability Index
change in functional scale: Oswestry Disability Index \[10 items, 0-5 points each, total 0(better) -50(worse) points\]
Time frame: 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 \[5 items, 1-3 points each, total 5(better) -15(worse) points\]
Time frame: week 1(before treatment) and week 5(1 week after treatment, primary endpoint)
Coping Strategy Questionnaire
change in coping scale: Coping Strategy Questionnaire \[8 subscales, total 48 items, 0-6 points each, divided into adaptive coping or disadaptive coping, not better or worse\]
Time frame: week 1(before treatment) and week 5(1 week after treatment, primary endpoint)
Beck Depression Inventory
change in emotion scale: Beck Depression Inventory \[21 items, 1-4 points each, total 21(better) -84(worse) points\]
Time frame: 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 \[40 items, 1-4 points each, divided into state anxiety or trait anxiety, not better or worse\]
Time frame: 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.
Time frame: week 1(before treatment) and week 5(1 week after treatment, primary endpoint)
Adverse events
number of participants with adverse events * assessment of severity: mild, moderate, severe * assessment of relation: definitely related, probably related, possibly related, probably not related, definitely not related, unknown
Time frame: baseline, 1-1, 1-2, 2-1, 2-2, 3-1, 3-2, 4-1, 4-2, 5, and 8 weeks
Plan to share: No
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Kyung Hee University Hospital at Gangdong