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.
Full Title of Study: “Acupuncture Treatment on Chronic Sciatica: the Efficacy, Mechanism, and Functional Neuroimaging Pain-network Study”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 31, 2019
- 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).
Arms, Groups and Cohorts
- Experimental: Acupuncture, low dosage
- treat as six acupoints
- Experimental: Acupuncture, high dosage
- treat as 18 acupoints
- No Intervention: Control group
- no acupuncture treatment, healthy control
Clinical Trial Outcome Measures
- 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
- 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
- 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
- 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
- Body Constitution Questionnaire (BCQ)
- Time Frame: 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).
Participating in This Clinical Trial
1. 35 – 70 y/o.
2. Low back or gluteal pain radiating into one leg.
3. Pain duration of at least two weeks.
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.
Gender Eligibility: All
Minimum Age: 35 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Taipei Veterans General Hospital, Taiwan
- Lotung Poh-Ai Hospital
- Provider of Information About this Clinical Study
- Overall Contact(s)
- Fang-Pey, Chen, MD, 886-2-28757452, email@example.com
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