Electroacupuncture for Sciatica Due to Intervertebral Disc Displacement
1 other identifier
interventional
324
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 28, 2014
CompletedFirst Posted
Study publicly available on registry
March 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMarch 14, 2014
March 1, 2014
2.2 years
February 28, 2014
March 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analog Scale(VAS) of Leg Pain
Change from baseline in VAS of Leg Pain at 6 weeks
Secondary Outcomes (6)
Visual Analog Scale(VAS) of Low Back Pain
Change from baseline in VAS of Low Back Pain at 6 weeks
Simplified McGill Pain Questionnaire (ST-MPQ)
Change from baseline in ST-MPQ at 6 weeks
Improved Roland Functional questionaire(RDQ)
Change from baseline in RDQ at 6 weeks
Likert Overall Recovery Self Rating Scale (7 points)
Change from baseline in Likert Overall Recovery Self Rating Scale at 6 weeks
The Medical Outcomes Study 36-Item Short -Form Health Survey Questionnaire (SF-36)
Change from baseline in SF-36 at 6 weeks
- +1 more secondary outcomes
Study Arms (3)
Electroacupuncture (EA)
EXPERIMENTALUse Electroacupuncture only
EA + Traction
OTHERUse electroacupuncture and traction together
EA + Traction + Oral Medication
OTHERCombine electroacupuncture, traction and oral medication (Voltaren and Vitamin B1) together for treatment
Interventions
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.
An electric pelvis traction in supine position will be applied. The treatment frequency and duration are the same as EA.
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.
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.
Eligibility Criteria
You may qualify if:
- Patients who meet the clinical diagnosis of sciatica caused by intervertebral disc displacement;
- Male or female, aged 18-65;
- Have completed informed consent form.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chengdu university of Traditonal Chinese Medcine
Chengdu, Sichuan, 610075, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Xi Wu, A.P.
School of Acupunture& Tuina, Chengdu University of Traditional Chinese Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 28, 2014
First Posted
March 14, 2014
Study Start
January 1, 2012
Primary Completion
April 1, 2014
Study Completion
June 1, 2014
Last Updated
March 14, 2014
Record last verified: 2014-03