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Efficacy and Mechanism of Acupuncture for Chronic Sciatica Using fMRI

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ClinicalTrials.gov Identifier: NCT03350789
Recruitment Status : Recruiting
First Posted : November 22, 2017
Last Update Posted : April 19, 2018
Sponsor:
Collaborator:
National Research Foundation of Korea
Information provided by (Responsible Party):
Mi-Yeon Song, Kyung Hee University Hospital at Gangdong

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Sciatica Device: Real acupuncture Device: Sham acupuncture Not Applicable

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Mechanism of Acupuncture on Patients With Chronic Sciatica Using fMRI: A Randomized, Patient-Assessor Blind, Sham-Controlled Clinical Trial
Actual Study Start Date : April 9, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Sciatica

Arm Intervention/treatment
Experimental: Real acupuncture
manual acupuncture + electroacupuncuture on acupoints, twice a week, for 4 weeks
Device: Real 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 Comparator: Sham acupuncture
sham acupuncture (no skin penetration) + placebo electroacupuncture without electrical stimulation on acupoints, twice a week, for 4 weeks
Device: Sham acupuncture
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




Primary Outcome Measures :
  1. Visual analogue scale for bothersomeness [ Time Frame: baseline, 1-1, 1-2, 2-1, 2-2, 3-1, 3-2, 4-1, 4-2, 5, and 8 weeks ]
    change in visual analoge scale for bothersomeness [range: 0(better)-100(worse) mm]


Secondary Outcome Measures :
  1. Visual analogue scale for pain intensity [ Time Frame: baseline, 1-1, 1-2, 2-1, 2-2, 3-1, 3-2, 4-1, 4-2, 5, and 8 weeks ]
    change in visual analogue scale for pain intensity [range: 0(better)-100(worse) mm]

  2. Oswestry Disability Index [ Time Frame: week 1(before treatment) and week 5(1 week after treatment, primary endpoint) ]
    change in functional scale: Oswestry Disability Index [10 items, 0-5 points each, total 0(better) -50(worse) points]

  3. EuroQol 5-Dimension [ Time Frame: week 1(before treatment) and week 5(1 week after treatment, primary endpoint) ]
    change in quality of life scale: EuroQol 5-Dimension [5 items, 1-3 points each, total 5(better) -15(worse) points]

  4. Coping Strategy Questionnaire [ Time Frame: week 1(before treatment) and week 5(1 week after treatment, primary endpoint) ]
    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]

  5. Beck Depression Inventory [ Time Frame: week 1(before treatment) and week 5(1 week after treatment, primary endpoint) ]
    change in emotion scale: Beck Depression Inventory [21 items, 1-4 points each, total 21(better) -84(worse) points]

  6. State-Trait Anxiety Inventory [ Time Frame: week 1(before treatment) and week 5(1 week after treatment, primary endpoint) ]
    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]

  7. blood oxygenation level dependent in Magnetic Resonance Image, functional [ Time Frame: week 1(before treatment) and week 5(1 week after treatment, primary endpoint) ]

    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.


  8. Adverse events [ Time Frame: baseline, 1-1, 1-2, 2-1, 2-2, 3-1, 3-2, 4-1, 4-2, 5, and 8 weeks ]

    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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adults 19 years of age or more and 70 years of age or less
  • clinical diagnosis of chronic sciatica (pain lasting 3 months or more)
  • 40mm or more of 100mm VAS for bothersomeness due to sciatica
  • volunteers through announcements and advertisements with written informed consent

Exclusion Criteria:

  • spinal surgery within the past 6 months
  • diagnosis of specific severe diseases resulting in sciatica: malignant tumor, spinal infection, inflammatory sponlylitis
  • progressive neurological deficit or severe neurological signs
  • other chronic diseases which could disturb the effect of treatments and the results of the study: cardiovascular diseases, autoimmune diseases, renal diseases, diabetic neuropathy, dementia, epilepsy
  • inadequate or insafe for the treatment of acupuncture/ electroacupuncture: hemorrhagic diseases, medication of anticoagulant, serious diabetes mellitus vulnerable to infections, serious cardiovascular diseases/ pacemaker, metal materials interior of the body
  • currently or might be pregnant
  • severe mental illness
  • currently participating other clinical trials
  • experience of acupuncture or electroacupuncture treatment, or taking medicines which might affect the symptom of pain such as corticosteroids, narcotics, NSAIDs or considered to be inadequate by the investigators within the past week (But they could be included only after going through 2 weeks of wash out period.)
  • difficulty of writing informed consent
  • inadeguate or insafe for MRI scanning: claustrophobia, metal materials interor of the body
  • other inadequate subjects assessed by the study investigators

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03350789


Contacts
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Contact: Koh-Woon Kim, Ph.D. 82-2-440-7577 garson83@hanmail.net

Locations
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Korea, Republic of
Kyung Hee University Hospital at Gangdong Recruiting
Seoul, Korea, Republic of, 05278
Contact: Koh-Woon Kim    82-2-440-7581    omdkimkw@khu.ac.kr   
Sponsors and Collaborators
Kyung Hee University Hospital at Gangdong
National Research Foundation of Korea
Investigators
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Principal Investigator: Mi-Yeon Song, Ph.D. Department of Rehabilitation Medicine of Korean Medicine, Kyung Hee University Hospital at Gangdong

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mi-Yeon Song, Professor, K.M.D., Ph.D., Kyung Hee University Hospital at Gangdong
ClinicalTrials.gov Identifier: NCT03350789     History of Changes
Other Study ID Numbers: KHNMC OH 2017-08-004-002
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mi-Yeon Song, Kyung Hee University Hospital at Gangdong:
acupuncture
sciatica
MRI, functional

Additional relevant MeSH terms:
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Sciatica
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neuralgia
Pain
Neurologic Manifestations
Signs and Symptoms