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Status unknownNCT02087462Updated Mar 14, 2014

Electroacupuncture for Sciatica Due to Intervertebral Disc Displacement

An interventional study of Electroacupuncture (EA) and Traction in Sciatica Due to Intervertebral Disc Disorder, sponsored by Chengdu University of Traditional Chinese Medicine. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-03-14.

Sponsored by Chengdu University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
324
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sciatica Due to Intervertebral Disc Disorder

Keywords

  • Sciatica
  • Electroacupuncture
  • Intervertebral disc displacement
03

In context

Intervertebral Disc Displacement

478 studies on the registry are indexed under Intervertebral Disc Displacement; 104 are open to participants now.

This study's planned enrollment of 324 is above the median of 63 across 344 interventional studies indexed under Intervertebral Disc Displacement.

Browse Intervertebral Disc Displacement studies →

Lead sponsor

Chengdu University of Traditional Chinese Medicine is the lead sponsor of 57 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
324 participants (estimated)

Study arms

  • Experimental
    Electroacupuncture (EA)

    Use Electroacupuncture only

    Other: Electroacupuncture (EA)

  • Other
    EA + Traction

    Use electroacupuncture and traction together

    Other: Electroacupuncture (EA) · Other: Traction

  • Other
    EA + Traction + Oral Medication

    Combine electroacupuncture, traction and oral medication (Voltaren and Vitamin B1) together for treatment

    Other: Electroacupuncture (EA) · Other: Traction · Drug: Voltaren · Drug: Vitamin B1

Interventions

  • OtherElectroacupuncture (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.

  • 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.

    Also known as: Voltaren or Votalin.

  • 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.

    Also known as: Vitamin B1 or Thiamin or Thiamine or Aneurin

06

What researchers measure

Primary outcomes

  1. Visual Analog Scale(VAS) of Leg Pain

    Time frame: Change from baseline in VAS of Leg Pain at 6 weeks

Secondary outcomes

  1. Visual Analog Scale(VAS) of Low Back Pain

    Time frame: Change from baseline in VAS of Low Back Pain at 6 weeks

  2. Simplified McGill Pain Questionnaire (ST-MPQ)

    Time frame: Change from baseline in ST-MPQ at 6 weeks

  3. Improved Roland Functional questionaire(RDQ)

    Time frame: Change from baseline in RDQ at 6 weeks

  4. Likert Overall Recovery Self Rating Scale (7 points)

    Time frame: Change from baseline in Likert Overall Recovery Self Rating Scale at 6 weeks

  5. The Medical Outcomes Study 36-Item Short -Form Health Survey Questionnaire (SF-36)

    Time frame: Change from baseline in SF-36 at 6 weeks

  6. Sciatica Frequency and Bothersome Index (SFBI)

    Time frame: Change from baseline in SFBI at 6 weeks

07

Study locations

1 of 1 sites recruiting
  • Chengdu university of Traditonal Chinese Medcine
    Chengdu, Sichuan 610075, China
    • Xi Wu, A.P. · Contact · wuxi403@hotmail.com · 86-15928830710
    • Song Jin, M.D. · Principal 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 · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02087462
Lead sponsor
Chengdu University of Traditional Chinese Medicine
Responsible party
Wu Xi (Principal Investigator, Chengdu University of Traditional Chinese Medicine) — Principal investigator
First posted
Mar 14, 2014
Start date
Jan 2012
Primary completion
Apr 2014 (estimated)
Completion
Jun 2014 (estimated)
Last update
Mar 14, 2014

Study contacts

Xi Wu, A.P.
Contact
wuxi403@hotmail.com
86-15928830710
Xi Wu, A.P.
study director · School of Acupunture& Tuina, Chengdu University of Traditional Chinese Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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