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

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ClinicalTrials.gov Identifier: NCT03489681
Recruitment Status : Recruiting
First Posted : April 5, 2018
Last Update Posted : August 6, 2018
Sponsor:
Collaborator:
Lotung Poh-Ai Hospital
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Brief 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 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.

Condition or disease Intervention/treatment Phase
Therapy, Acupuncture MRI, Functional Device: acupuncture Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The investigators performed prospective, randomized controlled study with three arms, the high-dose acupuncture, low-dose acupuncture and herb-medicine controlled groups.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupuncture Treatment on Chronic Sciatica: the Efficacy, Mechanism, and Functional Neuroimaging Pain-network Study
Actual Study Start Date : October 8, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Sciatica

Arm Intervention/treatment
Experimental: Acupuncture, low dosage
treat as six acupoints
Device: acupuncture

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).

Other Name: Ching Ming Mdical Device Co, Taipei, Taiwan, R.O.C

Experimental: Acupuncture, high dosage
treat as 18 acupoints
Device: acupuncture

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).

Other Name: Ching Ming Mdical Device Co, Taipei, Taiwan, R.O.C

No Intervention: Control group
no acupuncture treatment, healthy control



Primary Outcome Measures :
  1. Visual Analog Scale (VAS) [ Time Frame: Change from Baseline VAS at 4 weeks ]
    pain scale; from 0 to 10; score 0: no pain, score 10: unbearable pain, the higher values represent, the worse outcome


Secondary Outcome Measures :
  1. Sciatica Bothersome Index (SBI) [ Time Frame: Change from Baseline SBI at 4 weeks ]
    score 0: not bothersome; score 24: extremely bothersome, the higher values represent, the worse outcome

  2. Roland Disability Questionnaire for Sciatica (RDQS) [ Time Frame: Change from Baseline RDQS at 4 weeks ]
    Evaluation of Disability of sciatica; score 0: not the disability, score 24: most disability; the higher values represent, the worse outcome

  3. The World Health Organization Quality of Life -brief edition (WHOQOL-Brief) [ Time Frame: Change from Baseline WHOQOL-Brief at 4 weeks ]
    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



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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 35 - 70 y/o.
  2. Low back or gluteal pain radiating into one leg.
  3. Pain duration of at least two weeks.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489681


Contacts
Contact: Fang-Pey, Chen, MD 886-2-28757452 ext 333 fpchen@vghtpe.gov.tw

Locations
Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan
Contact: Fang-Pey, Chen, MD    886-2-28757453 ext 333    fpchen@vghtpe.gov.tw   
Contact: Ching-Hsiung Liu, MD    886-3-954331 ext 2253    chl@mail.pohai.org.tw   
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Lotung Poh-Ai Hospital

Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03489681     History of Changes
Other Study ID Numbers: 2016-01-014A
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Taipei Veterans General Hospital, Taiwan:
acupuncture, sciatica, default mode network

Additional relevant MeSH terms:
Sciatica
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms