Sciatica Due to Intervertebral Disc Disorder
Conditions
Keywords
Sciatica, Electroacupuncture, Intervertebral disc displacement
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.
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.
OTHERTraction
An electric pelvis traction in supine position will be applied. The treatment frequency and duration are the same as EA.
DRUGVoltaren
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.
DRUGVitamin B1
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.
Sponsors
Chengdu University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analog Scale(VAS) of Leg Pain | Change from baseline in VAS of Leg Pain at 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Visual Analog Scale(VAS) of Low Back Pain | Change from baseline in VAS of Low Back Pain 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 |
| Sciatica Frequency and Bothersome Index (SFBI) | Change from baseline in SFBI at 6 weeks |
| Likert Overall Recovery Self Rating Scale (7 points) | Change from baseline in Likert Overall Recovery Self Rating Scale at 6 weeks |
Countries
China
Contacts
Primary ContactXi Wu, A.P.
Outcome results
None listed