Clinical trial NCT02087462: Electroacupuncture for Sciatica Due to Intervertebral Disc Displacement
Official title: Electroacupuncture for Sciatica Due to Intervertebral Disc Displacement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sciatica Due to Intervertebral Disc Disorder
Keywords: Sciatica
Electroacupuncture
Intervertebral disc displacement
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual Analog Scale(VAS) of Leg Pain
timeFrame: Change from baseline in VAS of Leg Pain at 6 weeks
Secondary outcomes:
measure: Visual Analog Scale(VAS) of Low Back Pain
timeFrame: Change from baseline in VAS of Low Back Pain at 6 weeks
measure: Simplified McGill Pain Questionnaire (ST-MPQ)
timeFrame: Change from baseline in ST-MPQ at 6 weeks
measure: Improved Roland Functional questionaire(RDQ)
timeFrame: Change from baseline in RDQ at 6 weeks
measure: Likert Overall Recovery Self Rating Scale (7 points)
timeFrame: Change from baseline in Likert Overall Recovery Self Rating Scale at 6 weeks
measure: The Medical Outcomes Study 36-Item Short -Form Health Survey Questionnaire (SF-36)
timeFrame: Change from baseline in SF-36 at 6 weeks
measure: Sciatica Frequency and Bothersome Index (SFBI)
timeFrame: Change from baseline in SFBI at 6 weeks
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu university of Traditonal Chinese Medcine
state: Sichuan
Study officials:
affiliation: School of Acupunture& Tuina, Chengdu University of Traditional Chinese Medicine
name: Xi Wu, A.P.
role: STUDY_DIRECTOR
References: