Clinical trial NCT03350789: Efficacy and Mechanism of Acupuncture for Chronic Sciatica Using fMRI
Official title: Efficacy and Mechanism of Acupuncture on Patients With Chronic Sciatica Using fMRI: A Randomized, Patient-Assessor Blind, Sham-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Sciatica
Keywords: acupuncture
sciatica
MRI, functional
Lead sponsor: Kyung Hee University Hospital at Gangdong
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2017-11-22
Enrollment: 68
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Visual analogue scale for bothersomeness
timeFrame: baseline, 1-1, 1-2, 2-1, 2-2, 3-1, 3-2, 4-1, 4-2, 5, and 8 weeks
Secondary outcomes:
measure: Visual analogue scale for pain intensity
timeFrame: baseline, 1-1, 1-2, 2-1, 2-2, 3-1, 3-2, 4-1, 4-2, 5, and 8 weeks
measure: Oswestry Disability Index
timeFrame: week 1(before treatment) and week 5(1 week after treatment, primary endpoint)
measure: EuroQol 5-Dimension
timeFrame: week 1(before treatment) and week 5(1 week after treatment, primary endpoint)
measure: Coping Strategy Questionnaire
timeFrame: week 1(before treatment) and week 5(1 week after treatment, primary endpoint)
measure: Beck Depression Inventory
timeFrame: week 1(before treatment) and week 5(1 week after treatment, primary endpoint)
measure: State-Trait Anxiety Inventory
timeFrame: week 1(before treatment) and week 5(1 week after treatment, primary endpoint)
measure: blood oxygenation level dependent in Magnetic Resonance Image, functional
timeFrame: week 1(before treatment) and week 5(1 week after treatment, primary endpoint)
measure: Adverse events
timeFrame: baseline, 1-1, 1-2, 2-1, 2-2, 3-1, 3-2, 4-1, 4-2, 5, and 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
Study officials:
affiliation: Department of Rehabilitation Medicine of Korean Medicine, Kyung Hee University Hospital at Gangdong
name: Mi-Yeon Song, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim KW, Park K, Park HJ, Jahng GH, Jo DJ, Cho JH, Song EM, Shin WC, Yoon YJ, Kim SJ, Eun S, Song MY. Effect and neurophysiological mechanism of acupuncture in patients with chronic sciatica: protocol for a randomized, patient-assessor blind, sham-controlled clinical trial. Trials. 2019 Jan 16;20(1):56. doi: 10.1186/s13063-018-3164-8.