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

Not Applicable

• Conditions: Therapy, Acupuncture; MRI, Functional
• Interventions: Device: acupuncture

• Registration Number: NCT03489681
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-21
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-05
• Study Start: 2018-08-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-25
• Last Update Posted: 2019-01-28
• Primary Completion: 2019-12-31
• Study Completion: 2020-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture, low dosage	acupuncture	treat as six acupoints
Acupuncture, high dosage	acupuncture	treat as 18 acupoints

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	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

Name	Time	Method
Sciatica Bothersome Index (SBI)	Change from Baseline SBI at 4 weeks	score 0: not bothersome; score 24: extremely bothersome, the higher values represent, the worse outcome
The World Health Organization Quality of Life -brief edition (WHOQOL-Brief)	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
Body Constitution Questionnaire (BCQ)	baseline (1st time rsMRI examination)	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).
Roland Disability Questionnaire for Sciatica (RDQS)	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

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan