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Electroacupuncture for Sciatica Due to Intervertebral Disc Displacement

Primary Purpose

Sciatica Due to Intervertebral Disc Disorder

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Electroacupuncture (EA)
Traction
Voltaren
Vitamin B1
Sponsored by
Chengdu University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sciatica Due to Intervertebral Disc Disorder focused on measuring Sciatica, Electroacupuncture, Intervertebral disc displacement

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who meet the clinical diagnosis of sciatica caused by intervertebral disc displacement;
  • Male or female, aged 18-65;
  • Have completed informed consent form.

Exclusion Criteria:

  • Patients with sciatica caused by diseases such as piriformis syndrome, thickening of ligamentum flavus, acute lumbar strain, contusion, congenital spina bifid, lumbar and sacrum deformity, lumbar sacral vertebra joint disorder or proliferative osteoarthrosis;
  • Patients with urinary and fecal incontinence caused by acute lumbar disc herniation, huge or central type lumbar disc herniation sufferer in need of surgery;
  • Patients who fail to finish the basic treatment course, or have poor adherence;
  • Patients having a poor state, particularly unconsciousness, psychopath, severe osteoporosis, concurrent infection or bleeding susceptibly, or accompany with primary diseases in cardiovascular, digestion or hemopoietic systems and viscera as kidney, liver;
  • Pregnant or lactating women;
  • Patients in other clinical research.

Sites / Locations

  • Chengdu university of Traditonal Chinese MedcineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Other

Arm Label

Electroacupuncture (EA)

EA + Traction

EA + Traction + Oral Medication

Arm Description

Use Electroacupuncture only

Use electroacupuncture and traction together

Combine electroacupuncture, traction and oral medication (Voltaren and Vitamin B1) together for treatment

Outcomes

Primary Outcome Measures

Visual Analog Scale(VAS) of Leg Pain

Secondary Outcome Measures

Visual Analog Scale(VAS) of Low Back Pain
Simplified McGill Pain Questionnaire (ST-MPQ)
Improved Roland Functional questionaire(RDQ)
Likert Overall Recovery Self Rating Scale (7 points)
The Medical Outcomes Study 36-Item Short -Form Health Survey Questionnaire (SF-36)
Sciatica Frequency and Bothersome Index (SFBI)

Full Information

First Posted
February 28, 2014
Last Updated
March 13, 2014
Sponsor
Chengdu University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02087462
Brief Title
Electroacupuncture for Sciatica Due to Intervertebral Disc Displacement
Official Title
Electroacupuncture for Sciatica Due to Intervertebral Disc Displacement
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chengdu University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This multicenter randomized controlled trial (RCT) will evaluate the therapeutic effectiveness and health-economics of electroacupuncture for sciatica due to intervertebral disc displacement in 3 compared groups: electroacupuncture, electroacupuncture plus traction, electroacupuncture plus traction and medication.
Detailed Description
This is a multicenter RCT with 3 groups to determine the effectiveness and health economic evaluation of the electroacupuncture for sciatica due to intervertebral disc displacement in a population of adults aged 18-65. 324 participants who meet the inclusion criteria will be randomly allocated into 3 different groups, namely electroacupuncture group, electroacupuncture & traction group, electroacupuncture & traction & oral medication group. All participants will receive six-week treatment, the participants in electroacupuncture group will receive electroacupuncture only, electroacupuncture & traction group will receive both electroacupuncture and traction, and in electroacupuncture & traction & oral medication group all of the three therapies are adopted. The statistical analysis will be conducted by a third party who is masked to the allocation of participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sciatica Due to Intervertebral Disc Disorder
Keywords
Sciatica, Electroacupuncture, Intervertebral disc displacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
324 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electroacupuncture (EA)
Arm Type
Experimental
Arm Description
Use Electroacupuncture only
Arm Title
EA + Traction
Arm Type
Other
Arm Description
Use electroacupuncture and traction together
Arm Title
EA + Traction + Oral Medication
Arm Type
Other
Arm Description
Combine electroacupuncture, traction and oral medication (Voltaren and Vitamin B1) together for treatment
Intervention Type
Other
Intervention Name(s)
Electroacupuncture (EA)
Intervention Description
Main acupoints: Da chang shu (BL25), Huan tiao (GB30), bilateral Jiaji point of attacked lumbar vertebra, Ashi points, modifying points according to different patterns. Electroacupuncture: choose the dilatational wave, frequency is 2Hz/100Hz, electric current ranges from 0.1mA to 1.0mA, 30 mins per time. Treatment frequency: 5 times per week in the first 2 weeks, 3 times per week in the 3rd and 4th week, 2 times per week in the 5th and 6th week. Duration: 6 weeks.
Intervention Type
Other
Intervention Name(s)
Traction
Intervention Description
An electric pelvis traction in supine position will be applied. The treatment frequency and duration are the same as EA.
Intervention Type
Drug
Intervention Name(s)
Voltaren
Other Intervention Name(s)
Voltaren or Votalin.
Intervention Description
Medication: 50 mg, twice per day Treatment frequency: In the first 2 weeks, take medicine for continuous 5 days with a 2-day interval each week; in the 3rd and 4th week, take medicine every 2 days, totally 3 times each week; in the 5th and 6th week, take medicine every 3 days, totally 2 times each week. Duration: 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Vitamin B1
Other Intervention Name(s)
Vitamin B1 or Thiamin or Thiamine or Aneurin
Intervention Description
Medication: 10mg, twice per day. Treatment frequency: In the first 2 weeks, take medicine for continuous 5 days with a 2-day interval each week; in the 3rd and 4th week, take medicine every 2 days, totally 3 times each week; in the 5th and 6th week, take medicine every 3 days, totally 2 times each week. Duration: 6 weeks.
Primary Outcome Measure Information:
Title
Visual Analog Scale(VAS) of Leg Pain
Time Frame
Change from baseline in VAS of Leg Pain at 6 weeks
Secondary Outcome Measure Information:
Title
Visual Analog Scale(VAS) of Low Back Pain
Time Frame
Change from baseline in VAS of Low Back Pain at 6 weeks
Title
Simplified McGill Pain Questionnaire (ST-MPQ)
Time Frame
Change from baseline in ST-MPQ at 6 weeks
Title
Improved Roland Functional questionaire(RDQ)
Time Frame
Change from baseline in RDQ at 6 weeks
Title
Likert Overall Recovery Self Rating Scale (7 points)
Time Frame
Change from baseline in Likert Overall Recovery Self Rating Scale at 6 weeks
Title
The Medical Outcomes Study 36-Item Short -Form Health Survey Questionnaire (SF-36)
Time Frame
Change from baseline in SF-36 at 6 weeks
Title
Sciatica Frequency and Bothersome Index (SFBI)
Time Frame
Change from baseline in SFBI at 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who meet the clinical diagnosis of sciatica caused by intervertebral disc displacement; Male or female, aged 18-65; Have completed informed consent form. Exclusion Criteria: Patients with sciatica caused by diseases such as piriformis syndrome, thickening of ligamentum flavus, acute lumbar strain, contusion, congenital spina bifid, lumbar and sacrum deformity, lumbar sacral vertebra joint disorder or proliferative osteoarthrosis; Patients with urinary and fecal incontinence caused by acute lumbar disc herniation, huge or central type lumbar disc herniation sufferer in need of surgery; Patients who fail to finish the basic treatment course, or have poor adherence; Patients having a poor state, particularly unconsciousness, psychopath, severe osteoporosis, concurrent infection or bleeding susceptibly, or accompany with primary diseases in cardiovascular, digestion or hemopoietic systems and viscera as kidney, liver; Pregnant or lactating women; Patients in other clinical research.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xi Wu, A.P.
Phone
86-15928830710
Email
wuxi403@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xi Wu, A.P.
Organizational Affiliation
School of Acupunture& Tuina, Chengdu University of Traditional Chinese Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Chengdu university of Traditonal Chinese Medcine
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610075
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xi Wu, A.P.
Phone
86-15928830710
Email
wuxi403@hotmail.com
First Name & Middle Initial & Last Name & Degree
Song Jin, M.D.
First Name & Middle Initial & Last Name & Degree
Ling Qiu, physician
First Name & Middle Initial & Last Name & Degree
Min Chen, physician
First Name & Middle Initial & Last Name & Degree
Yongmao Chen, physician
First Name & Middle Initial & Last Name & Degree
Xiaohong Fan, physician
First Name & Middle Initial & Last Name & Degree
Tingting Liao, physician
First Name & Middle Initial & Last Name & Degree
Jie Zhang, Physician
First Name & Middle Initial & Last Name & Degree
Lei Lan, Doctor
First Name & Middle Initial & Last Name & Degree
Jun Lin, Postgraduate
First Name & Middle Initial & Last Name & Degree
Chen Du, Postgraduate

12. IPD Sharing Statement

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Electroacupuncture for Sciatica Due to Intervertebral Disc Displacement

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