Sciatica Due to Intervertebral Disc DisorderNCT02087462
Electroacupuncture for Sciatica Due to Intervertebral Disc Displacement
A study testing Electroacupuncture (EA), Traction and Voltaren in people with Sciatica Due to Intervertebral Disc Disorder, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sciatica Due to Intervertebral Disc Disorder
- What is being tested?
- Electroacupuncture (EA), Traction and Voltaren
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet the clinical diagnosis of sciatica caused by intervertebral disc displacement;
- Male or female, aged 18-65;
- Have completed informed consent form.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chengdu university of Traditonal Chinese Medcine
Chengdu, Sichuan, 610075
Xi Wu, A.P., 86-15928830710, wuxi403@hotmail.com
Song Jin, M.D.
About this study
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.
- Being tested
- Electroacupuncture (EA), Traction, Voltaren, Vitamin B1
- Keywords
- Sciatica, Electroacupuncture, Intervertebral disc displacement
- Medical subject headings
- Sciatica, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroacupuncture (EA)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.
TractionOther
An electric pelvis traction in supine position will be applied. The treatment frequency and duration are the same as EA.
VoltarenDrug
Also called Voltaren or Votalin.
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 B1Drug
Also called Vitamin B1 or Thiamin or Thiamine or Aneurin
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.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture (EA) | Experimental | Use Electroacupuncture only Receives: Other: Electroacupuncture (EA) |
| EA + Traction | Other | Use electroacupuncture and traction together Receives: Other: Electroacupuncture (EA); Other: Traction |
| EA + Traction + Oral Medication | Other | Combine electroacupuncture, traction and oral medication (Voltaren and Vitamin B1) together for treatment Receives: Other: Electroacupuncture (EA); Other: Traction; Drug: Voltaren; Drug: Vitamin B1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale(VAS) of Leg Pain
Measured: Change from baseline in VAS of Leg Pain at 6 weeks
Secondary outcomes (6)
Visual Analog Scale(VAS) of Low Back Pain
Measured: Change from baseline in VAS of Low Back Pain at 6 weeks
Simplified McGill Pain Questionnaire (ST-MPQ)
Measured: Change from baseline in ST-MPQ at 6 weeks
Improved Roland Functional questionaire(RDQ)
Measured: Change from baseline in RDQ at 6 weeks
Likert Overall Recovery Self Rating Scale (7 points)
Measured: 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)
Measured: Change from baseline in SF-36 at 6 weeks
Sciatica Frequency and Bothersome Index (SFBI)
Measured: Change from baseline in SFBI at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startJan 2012
- Primary completionApr 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sciatica Due to Intervertebral Disc DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Xi, Chengdu University of Traditional Chinese Medicine
- Investigators
- Xi Wu, A.P., Study director, School of Acupunture& Tuina, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087462
- Sponsor's protocol ID
- 2011SZ0080
- Status last verified
- Mar 2014
- First submitted
- 28 Feb 2014
- Last updated
- 14 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture for Sciatica Due to Intervertebral Disc Displacement
- ClinicalTrials.gov ID
- NCT02087462
- Acronym / sponsor ID
- 2011SZ0080
- Keywords
- Sciatica, Electroacupuncture, Intervertebral disc displacement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture (EA) | Experimental | Other: Electroacupuncture (EA)Use Electroacupuncture only |
| EA + Traction | Other | Other: Electroacupuncture (EA), Other: TractionUse electroacupuncture and traction together |
| EA + Traction + Oral Medication | Other | Other: Electroacupuncture (EA), Other: Traction, Drug: Voltaren, Drug: Vitamin B1Combine electroacupuncture, traction and oral medication (Voltaren and Vitamin B1) together for treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who meet the clinical diagnosis of sciatica caused by intervertebral disc displacement;
- Male or female, aged 18-65;
- Have completed informed consent form.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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, EA + Traction + Oral Medication, Electroacupuncture (EA) |
| TractionAn electric pelvis traction in supine position will be applied. The treatment frequency and duration are the same as EA. | Other | EA + Traction, EA + Traction + Oral Medication |
| VoltarenAlso: Voltaren or Votalin.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. | Drug | EA + Traction + Oral Medication |
| Vitamin B1Also: Vitamin B1 or Thiamin or Thiamine or AneurinMedication: 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. | Drug | EA + Traction + Oral Medication |
Primary outcome
Visual Analog Scale(VAS) of Leg Pain
Time frame: Change from baseline in VAS of Leg Pain at 6 weeks
6 secondary outcomes
Visual Analog Scale(VAS) of Low Back Pain
Time frame: 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
Improved Roland Functional questionaire(RDQ)
Time frame: 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
The Medical Outcomes Study 36-Item Short -Form Health Survey Questionnaire (SF-36)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2014.
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Not yet recruiting
Electroacupuncture for Insomnia in Patients With Chronic Sciatica Due to Lumbar Disc Herniation: a Randomized Controlled Trial
Sciatica, Lumbar Disc Herniation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xi Wu, A.P. study director
School of Acupunture& Tuina, Chengdu University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture (EA), Traction and Voltaren in people with Sciatica Due to Intervertebral Disc Disorder, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xi Wu, A.P. (86-15928830710, wuxi403@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale(VAS) of Leg Pain (time frame: Change from baseline in VAS of Leg Pain at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2014.