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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
324
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.
Chengdu university of Traditonal Chinese Medcine
Chengdu, Sichuan, China
RECRUITINGVisual Analog Scale(VAS) of Leg Pain
Time frame: Change from baseline in VAS of Leg Pain at 6 weeks
Visual Analog Scale(VAS) of Low Back Pain
Time frame: Change from baseline in VAS of Low Back Pain at 6 weeks
Simplified McGill Pain Questionnaire (ST-MPQ)
Time frame: Change from baseline in ST-MPQ at 6 weeks
Improved Roland Functional questionaire(RDQ)
Time frame: Change from baseline in RDQ at 6 weeks
Likert Overall Recovery Self Rating Scale (7 points)
Time frame: 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)
Time frame: Change from baseline in SF-36 at 6 weeks
Sciatica Frequency and Bothersome Index (SFBI)
Time frame: Change from baseline in SFBI at 6 weeks
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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.