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

Taipei Veterans General Hospital

Status: Unknown

Conditions: MRI, Functional; Therapy, Acupuncture

Treatments: Device: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03489681

2016-01-014A

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 35 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 3 patient groups

Acupuncture, low dosage

Experimental group

Description:

treat as six acupoints

Treatment:

Device: acupuncture

Acupuncture, high dosage

Experimental group

Description:

treat as 18 acupoints

Treatment:

Device: acupuncture

Control group

No Intervention group

Description:

no acupuncture treatment, healthy control