Efficacy and Mechanism of Acupuncture for Chronic Sciatica Using fMRI

Kyung Hee University

Status: Unknown

Conditions: Chronic Sciatica

Treatments: Device: Real acupuncture; Device: Sham acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03350789

KHNMC OH 2017-08-004-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups

Real acupuncture

Experimental group

Description:

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

Treatment:

Device: Real acupuncture

Sham acupuncture

Sham Comparator group

Description:

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

Treatment:

Device: Sham acupuncture