Efficacy and Mechanism of Acupuncture for Chronic Sciatica Using fMRI

NCT03350789 | Unknown

• 1 other identifier: KHNMC OH 2017-08-004-002
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Sciatica

Keywords

acupuncture; sciatica; MRI, functional

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Visual analogue scale for pain intensity

  baseline, 1-1, 1-2, 2-1, 2-2, 3-1, 3-2, 4-1, 4-2, 5, and 8 weeks

• Oswestry Disability Index

  week 1(before treatment) and week 5(1 week after treatment, primary endpoint)

• EuroQol 5-Dimension

  week 1(before treatment) and week 5(1 week after treatment, primary endpoint)

• Coping Strategy Questionnaire

  week 1(before treatment) and week 5(1 week after treatment, primary endpoint)

• Beck Depression Inventory

  week 1(before treatment) and week 5(1 week after treatment, primary endpoint)

Study Arms (2)

Real acupuncture

EXPERIMENTAL

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

Device: Real acupuncture

Sham acupuncture

SHAM COMPARATOR

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

Device: Sham acupuncture

Interventions

Real acupuncture 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

Real acupuncture

Sham acupuncture 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

Sham acupuncture

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• mm or more of 100mm VAS for bothersomeness due to sciatica
• volunteers through announcements and advertisements with written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyung Hee University Hospital at Gangdong: lead
• National Research Foundation of Korea: collaborator

Study Sites (1)

Kyung Hee University Hospital at Gangdong

Seoul, 05278, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 30651139 DERIVED

MeSH Terms

Conditions

Sciatica

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mi-Yeon Song, Ph.D.

  Department of Rehabilitation Medicine of Korean Medicine, Kyung Hee University Hospital at Gangdong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Koh-Woon Kim, Ph.D.

CONTACT

82-2-440-7577; garson83@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, K.M.D., Ph.D.

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 22, 2017
• Study Start: April 9, 2018
• Primary Completion: January 1, 2021
• Study Completion: February 1, 2021
• Last Updated: April 19, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)