Electroacupuncture for Sciatica Due to Intervertebral Disc Displacement

Sciatica Due to Intervertebral Disc Disorder Clinical Trial

Official title:

Electroacupuncture for Sciatica Due to Intervertebral Disc Displacement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02087462
• Other study ID #: 2011SZ0080
• Status: Recruiting
• Phase: N/A
• First received: February 28, 2014
• Last updated: March 13, 2014
• Start date: January 2012
• Est. completion date: June 2014

Study information

• Verified date: March 2014
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: Xi Wu, A.P.
• Phone: 86-15928830710
• Email: wuxi403[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 324
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement
• Sciatica
• Sciatica Due to Intervertebral Disc Disorder

Intervention

Other:
• Electroacupuncture (EA)
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.
• Traction
An electric pelvis traction in supine position will be applied. The treatment frequency and duration are the same as EA.

Drug:
• Voltaren
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.
• Vitamin 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.

Locations

Country	Name	City	State
China	Chengdu university of Traditonal Chinese Medcine	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale(VAS) of Leg Pain		Change from baseline in VAS of Leg Pain at 6 weeks	No
Secondary	Visual Analog Scale(VAS) of Low Back Pain		Change from baseline in VAS of Low Back Pain at 6 weeks	No
Secondary	Simplified McGill Pain Questionnaire (ST-MPQ)		Change from baseline in ST-MPQ at 6 weeks	No
Secondary	Improved Roland Functional questionaire(RDQ)		Change from baseline in RDQ at 6 weeks	No
Secondary	Likert Overall Recovery Self Rating Scale (7 points)		Change from baseline in Likert Overall Recovery Self Rating Scale at 6 weeks	No
Secondary	The Medical Outcomes Study 36-Item Short -Form Health Survey Questionnaire (SF-36)		Change from baseline in SF-36 at 6 weeks	No
Secondary	Sciatica Frequency and Bothersome Index (SFBI)		Change from baseline in SFBI at 6 weeks	No