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Efficacy and Mechanism of Acupuncture for Chronic Sciatica Using fMRI

Primary Purpose

Chronic Sciatica

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Real acupuncture

Sham acupuncture

About this trial

This is an interventional treatment trial for Chronic Sciatica focused on measuring acupuncture, sciatica, MRI, functional

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Kyung Hee University Hospital at GangdongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real acupuncture

Sham acupuncture

Arm Description

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

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

Outcomes

Primary Outcome Measures

Visual analogue scale for bothersomeness

change in visual analoge scale for bothersomeness [range: 0(better)-100(worse) mm]

Secondary Outcome Measures

Visual analogue scale for pain intensity

change in visual analogue scale for pain intensity [range: 0(better)-100(worse) mm]

Oswestry Disability Index

change in functional scale: Oswestry Disability Index [10 items, 0-5 points each, total 0(better) -50(worse) points]

EuroQol 5-Dimension

change in quality of life scale: EuroQol 5-Dimension [5 items, 1-3 points each, total 5(better) -15(worse) points]

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]

Beck Depression Inventory

change in emotion scale: Beck Depression Inventory [21 items, 1-4 points each, total 21(better) -84(worse) points]

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]

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.

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

Full Information

NCT ID

NCT03350789

First Posted

November 15, 2017

Last Updated

April 17, 2018

Sponsor

Kyung Hee University Hospital at Gangdong

Collaborators

National Research Foundation of Korea

1. Study Identification

Unique Protocol Identification Number

NCT03350789

Brief Title

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

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Unknown status

Study Start Date

April 9, 2018 (Actual)

Primary Completion Date

January 2021 (Anticipated)

Study Completion Date

February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kyung Hee University Hospital at Gangdong

Collaborators

National Research Foundation of Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Sciatica

Keywords

acupuncture, sciatica, MRI, functional

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Real acupuncture

Arm Type

Experimental

Arm Description

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

Arm Title

Sham acupuncture

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Real acupuncture

Intervention Description

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

Intervention Name(s)

Sham acupuncture

Intervention Description

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

Primary Outcome Measure Information:

Title

Visual analogue scale for bothersomeness

Description

change in visual analoge scale for bothersomeness [range: 0(better)-100(worse) mm]

Time Frame

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

Secondary Outcome Measure Information:

Title

Visual analogue scale for pain intensity

Description

change in visual analogue scale for pain intensity [range: 0(better)-100(worse) mm]

Time Frame

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

Title

Oswestry Disability Index

Description

change in functional scale: Oswestry Disability Index [10 items, 0-5 points each, total 0(better) -50(worse) points]

Time Frame