Efficacy and Mechanism of Acupuncture for Chronic Sciatica Using fMRI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-09

Study Completion Date

2021-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Sciatica

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Real acupuncture

manual acupuncture + electroacupuncuture on acupoints, twice a week, for 4 weeks

Group Type EXPERIMENTAL

Real acupuncture

Intervention Type 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

Sham acupuncture

sham acupuncture (no skin penetration) + placebo electroacupuncture without electrical stimulation on acupoints, twice a week, for 4 weeks

Group Type SHAM_COMPARATOR

Sham acupuncture

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes