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

NCT03489681 | Unknown

• 1 other identifier: 2016-01-014A
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Therapy, Acupuncture; MRI, Functional

Keywords

acupuncture, sciatica, default mode network

Outcome Measures

Primary Outcomes (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

  Change from Baseline VAS at 4 weeks

Secondary Outcomes (4)

• Sciatica Bothersome Index (SBI)

  Change from Baseline SBI at 4 weeks

• Roland Disability Questionnaire for Sciatica (RDQS)

  Change from Baseline RDQS at 4 weeks

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

  Change from Baseline WHOQOL-Brief at 4 weeks

• Body Constitution Questionnaire (BCQ)

  baseline (1st time rsMRI examination)

Study Arms (3)

Acupuncture, low dosage

EXPERIMENTAL

treat as six acupoints

Device: acupuncture

Acupuncture, high dosage

EXPERIMENTAL

treat as 18 acupoints

Device: acupuncture

Control group

NO INTERVENTION

no acupuncture treatment, healthy control

Interventions

acupuncture DEVICE

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).

Also known as: Ching Ming Mdical Device Co, Taipei, Taiwan, R.O.C

Acupuncture, high dosage; Acupuncture, low dosage

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• Lotung Poh-Ai Hospital: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 32021387 DERIVED

MeSH Terms

Conditions

Sciatica

Interventions

Acupuncture Therapy

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Fang-Pey, Chen, MD

CONTACT

886-2-28757452; fpchen@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The investigators performed a prospective, randomized controlled study with three arms, the high-dose acupuncture, low-dose acupuncture, and healthy controlled groups.

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: April 5, 2018
• Study Start: August 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: January 31, 2020
• Last Updated: January 28, 2019

Record last verified: 2019-01

Locations

TW (1)