Electroacupuncture for Sciatica Due to Intervertebral Disc Displacement

Not Applicable

• Conditions: Sciatica Due to Intervertebral Disc Disorder
• Interventions: Other: Electroacupuncture (EA); Other: Traction; Drug: Voltaren; Drug: Vitamin B1

• Registration Number: NCT02087462
• Lead Sponsor: Chengdu University of Traditional Chinese Medicine

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2014-02-28
• Status Verified: 2014-03
• Study First Submitted QC: 2014-03-13
• Last Update Submitted: 2014-03-13
• Study First Posted: 2014-03-14
• Last Update Posted: 2014-03-14
• Primary Completion: 2014-04
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 324

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electroacupuncture (EA)	Electroacupuncture (EA)	Use Electroacupuncture only
EA + Traction	Electroacupuncture (EA)	Use electroacupuncture and traction together
EA + Traction	Traction	Use electroacupuncture and traction together
EA + Traction + Oral Medication	Electroacupuncture (EA)	Combine electroacupuncture, traction and oral medication (Voltaren and Vitamin B1) together for treatment
EA + Traction + Oral Medication	Traction	Combine electroacupuncture, traction and oral medication (Voltaren and Vitamin B1) together for treatment
EA + Traction + Oral Medication	Voltaren	Combine electroacupuncture, traction and oral medication (Voltaren and Vitamin B1) together for treatment
EA + Traction + Oral Medication	Vitamin B1	Combine electroacupuncture, traction and oral medication (Voltaren and Vitamin B1) together for treatment

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale(VAS) of Leg Pain	Change from baseline in VAS of Leg Pain at 6 weeks

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Chengdu university of Traditonal Chinese Medcine; 🇨🇳 Chengdu, Sichuan, China