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Therapy, AcupunctureNCT03489681

Acupuncture Treatment for Chronic Sciatica: the Neuroimaging Pain-network Study

A study testing acupuncture in people with Therapy, Acupuncture and MRI, Functional, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Sciatica is a common pain disorder in the neurological clinic that typically present as low back or gluteal pain and may radiate to one leg with motor or sensory complaint. Sciatica has drawn more attention worldwide as a public health issue for its pain disability, high prevalence and significant medical and economic… Read more about this study

Who is it for?
Ages 35 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Therapy, Acupuncture, MRI, Functional
What is being tested?
acupuncture
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTaiwan
Study dates
1 Aug 2018to 31 Jan 2020
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 35 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 35 - 70 y/o.
  • Low back or gluteal pain radiating into one leg.
  • Pain duration of at least two weeks.

Who cannot join

  • Known or suspected severe spinal pathology (for example, cauda equina syndrome, or spinal fracture).
  • Pregnant or breastfeeding women.
  • Scheduled or being considered for spinal surgery or interventional procedures for sciatica during the 8-week treatment period.
  • Administration of sedative or analgesics within 24 h before the fMRI scan.
  • Comorbidities include systemic malignancy, bleeding tendency, rheumatic arthritis and other known autoimmune diseases.
  • Focal neurologic deficits with progressive or disabling symptoms
Show all 10Show fewer
  • History of received acupuncture treatment in the past one month.
  • Any contraindication related to acupuncture and MRI.
  • Visual analog scale < 3.
  • Low back pain without sciatica.

Trial locations and contacts

1 site in 1 country.

Fang-Pey, Chen, MD contact

886-2-28757452 ext. 333

fpchen@vghtpe.gov.tw

Taiwan1 site, 1 recruiting

  • Taipei Veterans General Hospital

    Taipei

    Fang-Pey, Chen, MD, 886-2-28757453 ext. 333, fpchen@vghtpe.gov.tw

    Ching-Hsiung Liu, MD, 886-3-954331 ext. 2253, chl@mail.pohai.org.tw

    Recruiting

Other trials in Taiwan

About this study

Official title: Acupuncture Treatment on Chronic Sciatica: the Efficacy, Mechanism, and Functional Neuroimaging Pain-network Study

Sciatica is a common pain disorder in the neurological clinic that typically present as low back or gluteal pain and may radiate to one leg with motor or sensory complaint. Sciatica has drawn more attention worldwide as a public health issue for its pain disability, high prevalence and significant medical and economic burden. A meta-analysis of sciatica treatment revealed discectomy, epidural injections, non-opioid analgesics, and acupuncture might relieve pain. However, the central effect of acupuncture-induced analgesia and its functional connectivities in various brain region remain unclear. Besides, the number of acupoints selection and its correlation in functional connectivity also need to be discussed. This clinical trial would collect the sciatica subjects assign by intent to treat, divided to acupuncture and non-acupuncture herbal control group. The treatment of acupuncture assigns randomized as high dose and low dose acupuncture group. The acupuncture will perform two times a week for four weeks. The primary outcomes are visual analog scale for pain and sciatica bothersomeness index; the secondary outcomes are Roland's disability questionnaire for sciatica, WHOQOL, and traditional Chinese medical constitutional scale. The functional magnetic resonance imaging scan would apply at the baseline and after four weeks' treatment. This study aims to explore the model of DMN in sciatica patients; it's central effect in different stimulation modality and to investigate the mechanism of the long-lasting, sustained impact in different acupuncture dosage.

Being tested
acupuncture
Keywords
acupuncture, sciatica, default mode network
Medical subject headings
Sciatica

What participants receive

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

  • acupunctureDevice

    Also called Ching Ming Mdical Device Co, Taipei, Taiwan, R.O.C

    Low dose group:

    Twenty patients will assign for low dose group treatment; as six acupoints as Shensu (BL 54), Huantiao (GB 30), Weizhong (BL 40), Yanglingquan (GB 34), Kunlun (BL 60), Juegu (GB 39).

    High dose group:

    Twenty patients will assign for high dose group treatment. These acupoints contains of eighteen acupoints, as Shenshu (BL 54), Dachangshu (BL 25) , Xiaochangshu (BL 27), Huantiao (GB 30), Yinmen (BL 37) , Zhibien (BL 54), Chengfu (BL 36), Fengshi (GB 31), Weizhong (BL 40), Zusanli (ST 36) Yanglingquan (GB 34), Yinlingquan (SP 9), Feiyang (BL 58), Sanyinjiao (SP 6), Juegu (GB 39), KunLun (BL 60), , Taixi (KI 3), Shenmai (BL 62).

Study groups in NCT03489681
Study groupRoleWhat they receive
Acupuncture, low dosageExperimentaltreat as six acupoints
Receives: Device: acupuncture
Acupuncture, high dosageExperimentaltreat as 18 acupoints
Receives: Device: acupuncture
Control groupNo interventionno acupuncture treatment, healthy control

What is being measured

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

  1. Visual Analog Scale (VAS)

    pain scale; from 0 to 10; score 0: no pain, score 10: unbearable pain, the higher values represent, the worse outcome

    Measured: Change from Baseline VAS at 4 weeks

Secondary outcomes (4)

  1. Sciatica Bothersome Index (SBI)

    score 0: not bothersome; score 24: extremely bothersome, the higher values represent, the worse outcome

    Measured: Change from Baseline SBI at 4 weeks

  2. Roland Disability Questionnaire for Sciatica (RDQS)

    Evaluation of Disability of sciatica; score 0: not the disability, score 24: most disability; the higher values represent, the worse outcome

    Measured: Change from Baseline RDQS at 4 weeks

  3. The World Health Organization Quality of Life -brief edition (WHOQOL-Brief)

    evaluation of daily life quality; the more the scores, the better the quality of life subscale: 1 Physical health (score 4-20); 2 Psychological (score 4-20); 3 Social relationships(score 4-20); 4 Environment (score 4- 20), total score: minimum 8, maximum 80); the higher values represent, the better outcome

    Measured: Change from Baseline WHOQOL-Brief at 4 weeks

  4. Body Constitution Questionnaire (BCQ)

    Traditional Chinese medicine (TCM), is an ancient system of personalized medicine based on body constitution (BC) theory. BC is the fundamental physiological component of a person, and different BC types are variously susceptible to disease and affect the development and prognosis of diseases. Patient classification is important in TCM, Body Constitution Questionnaire (BCQ) is developed by Prof. Su (Taiwan,2009); which classified people with their personalized trait 'body constitution' and scoring as 'Yin- deficiency', Yang-deficiency' and 'Phlegm \& dampness'. The more the scores, the more tendency of the BCQ sub-type( cut off point, 30 points, 31 points, and 27 points respectively).

    Measured: baseline (1st time rsMRI examination)

Timeline

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

  1. First posted5 Apr 2018
  2. Study start1 Aug 2018
  3. Primary completion31 Dec 2019 (estimated)
  4. Study completion31 Jan 2020 (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
Model description
The investigators performed a prospective, randomized controlled study with three arms, the high-dose acupuncture, low-dose acupuncture, and healthy controlled groups.
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03489681
Sponsor's protocol ID
2016-01-014A
Status last verified
Jan 2019
First submitted
21 Dec 2017
Last updated
28 Jan 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Liu CH, Kung YY, Lin CL, Yang JL, Wu TP, Lin HC, Chang YK, Chang CM, Chen FP. Therapeutic Efficacy and the Impact of the "Dose" Effect of Acupuncture to Treat Sciatica: A Randomized Controlled Pilot Study. J Pain Res. 2019 Dec 31;12:3511-3520. doi: 10.2147/JPR.S210672. eCollection 2019.

    PubMed 32021387

Questions about this trial

What is this clinical trial studying?

A study testing acupuncture in people with Therapy, Acupuncture and MRI, Functional, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

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 3 inclusion and 10 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 28 Jan 2019. 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 Taiwan. 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. 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 Fang-Pey, Chen, MD (886-2-28757452 ext. 333, fpchen@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (VAS) (time frame: Change from Baseline VAS at 4 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 NCT03489681, 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 28 Jan 2019.

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