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

Study Overview
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Brief Summary
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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.

Official Title
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Acupuncture Treatment on Chronic Sciatica: the Efficacy, Mechanism, and Functional Neuroimaging Pain-network Study

Conditions
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Therapy, Acupuncture, MRI, Functional

Intervention / Treatment
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* Device: acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 35 - 70 y/o. Low back or gluteal pain radiating into one leg. Pain duration of at least two weeks. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The investigators performed a prospective, randomized controlled study with three arms, the high-dose acupuncture, low-dose acupuncture, and healthy controlled groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture, low dosage<br>treat as six acupoints | Device: acupuncture<br>* 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).<br>* Other names: Ching Ming Mdical Device Co, Taipei, Taiwan, R.O.C;|
| Experimental: Acupuncture, high dosage<br>treat as 18 acupoints | Device: acupuncture<br>* 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).<br>* Other names: Ching Ming Mdical Device Co, Taipei, Taiwan, R.O.C;|
| No Intervention: Control group<br>no acupuncture treatment, healthy control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, sciatica, default mode network