Electroacupuncture for Sciatica Due to Intervertebral Disc Displacement

March 13, 2014 updated by: Wu Xi, Chengdu University of Traditional Chinese Medicine
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

324

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610075
        • Recruiting
        • Chengdu university of Traditonal Chinese Medcine
        • Contact:
        • Principal Investigator:
          • Song Jin, M.D.
        • Sub-Investigator:
          • Ling Qiu, physician
        • Sub-Investigator:
          • Min Chen, physician
        • Sub-Investigator:
          • Yongmao Chen, physician
        • Sub-Investigator:
          • Xiaohong Fan, physician
        • Sub-Investigator:
          • Tingting Liao, physician
        • Sub-Investigator:
          • Jie Zhang, Physician
        • Sub-Investigator:
          • Lei Lan, Doctor
        • Sub-Investigator:
          • Jun Lin, Postgraduate
        • Sub-Investigator:
          • Chen Du, Postgraduate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electroacupuncture (EA)
Use Electroacupuncture only
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.
Other: EA + Traction
Use electroacupuncture and traction together
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.

Other: Traction
An electric pelvis traction in supine position will be applied. The treatment frequency and duration are the same as EA.
Other: EA + Traction + Oral Medication
Combine electroacupuncture, traction and oral medication (Voltaren and Vitamin B1) together for treatment
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.

Other: 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.

Other Names:
  • Voltaren or Votalin.
Drug: 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.

Other Names:
  • Vitamin B1 or Thiamin or Thiamine or Aneurin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Analog Scale(VAS) of Leg Pain
Time Frame: Change from baseline in VAS of Leg Pain at 6 weeks
Change from baseline in VAS of Leg Pain at 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual Analog Scale(VAS) of Low Back Pain
Time Frame: Change from baseline in VAS of Low Back Pain at 6 weeks
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
Change from baseline in ST-MPQ at 6 weeks
Improved Roland Functional questionaire(RDQ)
Time Frame: Change from baseline in RDQ at 6 weeks
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
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
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
Change from baseline in SFBI at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu University of Traditional Chinese Medicine

Investigators

  • Study Director: Xi Wu, A.P., School of Acupunture& Tuina, Chengdu University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

February 28, 2014

First Submitted That Met QC Criteria

March 13, 2014

First Posted (Estimate)

March 14, 2014

Study Record Updates

Last Update Posted (Estimate)

March 14, 2014

Last Update Submitted That Met QC Criteria

March 13, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011SZ0080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sciatica Due to Intervertebral Disc Disorder

Clinical Trials on Electroacupuncture (EA)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe