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

MRI, Functional Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03489681
• Other study ID #: 2016-01-014A
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: January 2019
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Fang-Pey, Chen, MD
• Phone: 886-2-28757452
• Email: fpchen[@]vghtpe.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• MRI, Functional
• Sciatica
• Therapy, Acupuncture

Intervention

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).

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan	Lotung Poh-Ai Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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)