Electroacupuncture for Sciatica Due to Intervertebral Disc Displacement

NCT ID: NCT02087462

Last Updated: 2014-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Sciatica Due to Intervertebral Disc Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Electroacupuncture (EA)

Use Electroacupuncture only

Group Type EXPERIMENTAL

Electroacupuncture (EA)

Intervention Type OTHER

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.

EA + Traction

Use electroacupuncture and traction together

Group Type OTHER

Electroacupuncture (EA)

Intervention Type OTHER

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

Intervention Type OTHER

An electric pelvis traction in supine position will be applied. The treatment frequency and duration are the same as EA.

EA + Traction + Oral Medication

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

Group Type OTHER

Electroacupuncture (EA)

Intervention Type OTHER

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

Intervention Type OTHER

An electric pelvis traction in supine position will be applied. The treatment frequency and duration are the same as EA.

Voltaren

Intervention Type DRUG

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

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type OTHER

Traction

An electric pelvis traction in supine position will be applied. The treatment frequency and duration are the same as EA.

Intervention Type OTHER

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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Voltaren or Votalin. Vitamin B1 or Thiamin or Thiamine or Aneurin

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Wu Xi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xi Wu, A.P.

Role: STUDY_DIRECTOR

School of Acupunture& Tuina, Chengdu University of Traditional Chinese Medicine

Locations

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Chengdu university of Traditonal Chinese Medcine

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xi Wu, A.P.

Role: CONTACT

86-15928830710

Facility Contacts

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Xi Wu, A.P.

Role: primary

86-15928830710

Other Identifiers

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2011SZ0080

Identifier Type: -

Identifier Source: org_study_id

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