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

Primary Purpose

Therapy, Acupuncture, MRI, Functional

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
acupuncture
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Therapy, Acupuncture focused on measuring acupuncture, sciatica, default mode network

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Acupuncture, low dosage

Acupuncture, high dosage

Control group

Arm Description

treat as six acupoints

treat as 18 acupoints

no acupuncture treatment, healthy control

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Sciatica Bothersome Index (SBI)
score 0: not bothersome; score 24: extremely bothersome, the higher values represent, the worse outcome
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
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
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).

Full Information

First Posted
December 21, 2017
Last Updated
January 25, 2019
Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
Lotung Poh-Ai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03489681
Brief Title
Acupuncture Treatment for Chronic Sciatica: the Neuroimaging Pain-network Study
Official Title
Acupuncture Treatment on Chronic Sciatica: the Efficacy, Mechanism, and Functional Neuroimaging Pain-network Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
January 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
Lotung Poh-Ai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Therapy, Acupuncture, MRI, Functional
Keywords
acupuncture, sciatica, default mode network

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture, low dosage
Arm Type
Experimental
Arm Description
treat as six acupoints
Arm Title
Acupuncture, high dosage
Arm Type
Experimental
Arm Description
treat as 18 acupoints
Arm Title
Control group
Arm Type
No Intervention
Arm Description
no acupuncture treatment, healthy control
Intervention Type
Device
Intervention Name(s)
acupuncture
Other Intervention Name(s)
Ching Ming Mdical Device Co, Taipei, Taiwan, R.O.C
Intervention Description
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).
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
pain scale; from 0 to 10; score 0: no pain, score 10: unbearable pain, the higher values represent, the worse outcome
Time Frame
Change from Baseline VAS at 4 weeks
Secondary Outcome Measure Information:
Title
Sciatica Bothersome Index (SBI)
Description
score 0: not bothersome; score 24: extremely bothersome, the higher values represent, the worse outcome
Time Frame
Change from Baseline SBI at 4 weeks
Title
Roland Disability Questionnaire for Sciatica (RDQS)
Description
Evaluation of Disability of sciatica; score 0: not the disability, score 24: most disability; the higher values represent, the worse outcome
Time Frame
Change from Baseline RDQS at 4 weeks
Title
The World Health Organization Quality of Life -brief edition (WHOQOL-Brief)
Description
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
Time Frame
Change from Baseline WHOQOL-Brief at 4 weeks
Title
Body Constitution Questionnaire (BCQ)
Description
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).
Time Frame
baseline (1st time rsMRI examination)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fang-Pey, Chen, MD
Phone
886-2-28757452
Ext
333
Email
fpchen@vghtpe.gov.tw
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang-Pey, Chen, MD
Phone
886-2-28757453
Ext
333
Email
fpchen@vghtpe.gov.tw
First Name & Middle Initial & Last Name & Degree
Ching-Hsiung Liu, MD
Phone
886-3-954331
Ext
2253
Email
chl@mail.pohai.org.tw

12. IPD Sharing Statement

Citations:
PubMed Identifier
32021387
Citation
Liu CH, Kung YY, Lin CL, Yang JL, Wu TP, Lin HC, Chang YK, Chang CM, Chen FP. Therapeutic Efficacy and the Impact of the "Dose" Effect of Acupuncture to Treat Sciatica: A Randomized Controlled Pilot Study. J Pain Res. 2019 Dec 31;12:3511-3520. doi: 10.2147/JPR.S210672. eCollection 2019.
Results Reference
derived

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

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