Clinical trial NCT03489681: Acupuncture Treatment for Chronic Sciatica: the Neuroimaging Pain-network Study
Official title: Acupuncture Treatment on Chronic Sciatica: the Efficacy, Mechanism, and Functional Neuroimaging Pain-network Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Therapy, Acupuncture
MRI, Functional
Keywords: acupuncture, sciatica, default mode network
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: Lotung Poh-Ai Hospital
First posted: 2018-04-05
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators performed a prospective, randomized controlled study with three arms, the high-dose acupuncture, low-dose acupuncture, and healthy controlled groups.
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Change from Baseline VAS at 4 weeks
Secondary outcomes:
measure: Sciatica Bothersome Index (SBI)
timeFrame: Change from Baseline SBI at 4 weeks
measure: Roland Disability Questionnaire for Sciatica (RDQS)
timeFrame: Change from Baseline RDQS at 4 weeks
measure: The World Health Organization Quality of Life -brief edition (WHOQOL-Brief)
timeFrame: Change from Baseline WHOQOL-Brief at 4 weeks
measure: Body Constitution Questionnaire (BCQ)
timeFrame: baseline (1st time rsMRI examination)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References:
citation: 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.