Efficacy and Mechanism of Acupuncture for Chronic Sciatica Using fMRI

Chronic Sciatica Clinical Trial

Official title:

Efficacy and Mechanism of Acupuncture on Patients With Chronic Sciatica Using fMRI: A Randomized, Patient-Assessor Blind, Sham-Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03350789
• Other study ID #: KHNMC OH 2017-08-004-002
• Status: Recruiting
• Phase: N/A
• First received: November 15, 2017
• Last updated: April 17, 2018
• Start date: April 9, 2018
• Est. completion date: February 2021

Study information

• Verified date: April 2018
• Source: Kyung Hee University Hospital at Gangdong
• Contact: Koh-Woon Kim, Ph.D.
• Phone: 82-2-440-7577
• Email: garson83[@]hanmail.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: February 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Sciatica
• Sciatica

Intervention

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 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

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Kyung Hee University Hospital at Gangdong	National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Oswestry Disability Index	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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	baseline, 1-1, 1-2, 2-1, 2-2, 3-1, 3-2, 4-1, 4-2, 5, and 8 weeks