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Chronic SciaticaNCT03350789

Efficacy and Mechanism of Acupuncture for Chronic Sciatica Using fMRI

A study testing Real acupuncture in people with Chronic Sciatica, run by Kyung Hee University Hospital at Gangdong at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Sciatica
What is being tested?
Real acupuncture
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
68 participants
Where
1 siteSouth Korea
Study dates
9 Apr 2018to Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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 locations and contacts

1 site in 1 country.

Koh-Woon Kim, Ph.D. contact

82-2-440-7577

garson83@hanmail.net

South Korea1 site, 1 recruiting

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278

    Koh-Woon Kim, 82-2-440-7581, omdkimkw@khu.ac.kr

    Recruiting

Other trials in South Korea

About this study

Official title: Efficacy and Mechanism of Acupuncture on Patients With Chronic Sciatica Using fMRI: A Randomized, Patient-Assessor Blind, Sham-Controlled Clinical Trial

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.

Read the 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.

Being tested
Real acupuncture, Sham acupuncture
Keywords
acupuncture, sciatica, MRI, functional
Medical subject headings
Sciatica

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Real acupunctureDevice

    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 acupunctureDevice

    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

Study groups in NCT03350789
Study groupRoleWhat they receive
Real acupunctureExperimentalmanual acupuncture + electroacupuncuture on acupoints, twice a week, for 4 weeks
Receives: Device: Real acupuncture
Sham acupunctureSham comparatorsham acupuncture (no skin penetration) + placebo electroacupuncture without electrical stimulation on acupoints, twice a week, for 4 weeks
Receives: Device: Sham acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual analogue scale for bothersomeness

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

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

Secondary outcomes (8)

  1. Visual analogue scale for pain intensity

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

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

  2. Oswestry Disability Index

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

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

  3. EuroQol 5-Dimension

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

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

  4. 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]

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

  5. Beck Depression Inventory

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

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

  6. 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]

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

  7. 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.

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

  8. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2017
  2. Study start9 Apr 2018
  3. Primary completionJan 2021 (estimated)
  4. Study completionFeb 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03350789
Sponsor's protocol ID
KHNMC OH 2017-08-004-002
Status last verified
Apr 2018
First submitted
15 Nov 2017
Last updated
19 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30651139

Questions about this trial

What is this clinical trial studying?

A study testing Real acupuncture in people with Chronic Sciatica, run by Kyung Hee University Hospital at Gangdong at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Koh-Woon Kim, Ph.D. (82-2-440-7577, garson83@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual analogue scale for bothersomeness (time frame: baseline, 1-1, 1-2, 2-1, 2-2, 3-1, 3-2, 4-1, 4-2, 5, and 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03350789, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.

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