- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03489681
Acupuncture Treatment for Chronic Sciatica: the Neuroimaging Pain-network Study
Acupuncture Treatment on Chronic Sciatica: the Efficacy, Mechanism, and Functional Neuroimaging Pain-network Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fang-Pey, Chen, MD
- Phone Number: 333 886-2-28757452
- Email: fpchen@vghtpe.gov.tw
Study Locations
-
-
-
Taipei, Taiwan
- Recruiting
- Taipei Veterans General Hospital
-
Contact:
- Fang-Pey, Chen, MD
- Phone Number: 333 886-2-28757453
- Email: fpchen@vghtpe.gov.tw
-
Contact:
- Ching-Hsiung Liu, MD
- Phone Number: 2253 886-3-954331
- Email: chl@mail.pohai.org.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acupuncture, low dosage
treat as six acupoints
|
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).
Other Names:
|
Experimental: Acupuncture, high dosage
treat as 18 acupoints
|
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).
Other Names:
|
No Intervention: Control group
no acupuncture treatment, healthy control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change from Baseline VAS at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change from Baseline SBI at 4 weeks
|
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
|
Change from Baseline RDQS at 4 weeks
|
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
|
Change from Baseline WHOQOL-Brief at 4 weeks
|
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).
|
baseline (1st time rsMRI examination)
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-01-014A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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