Electroacupuncture for Sciatica Due to Intervertebral Disc Displacement

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Chengdu University of Traditional Chinese Medicine
Sponsor:
Information provided by (Responsible Party):
Wu Xi, Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT02087462
First received: February 28, 2014
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Sciatica Due to Intervertebral Disc Disorder
Other: Electroacupuncture (EA)
Other: Traction
Drug: Voltaren
Drug: Vitamin B1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Electroacupuncture for Sciatica Due to Intervertebral Disc Displacement

Resource links provided by NLM:


Further study details as provided by Chengdu University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Visual Analog Scale(VAS) of Leg Pain [ Time Frame: Change from baseline in VAS of Leg Pain at 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual Analog Scale(VAS) of Low Back Pain [ Time Frame: Change from baseline in VAS of Low Back Pain at 6 weeks ] [ Designated as safety issue: No ]
  • Simplified McGill Pain Questionnaire (ST-MPQ) [ Time Frame: Change from baseline in ST-MPQ at 6 weeks ] [ Designated as safety issue: No ]
  • Improved Roland Functional questionaire(RDQ) [ Time Frame: Change from baseline in RDQ at 6 weeks ] [ Designated as safety issue: No ]
  • Likert Overall Recovery Self Rating Scale (7 points) [ Time Frame: Change from baseline in Likert Overall Recovery Self Rating Scale at 6 weeks ] [ Designated as safety issue: No ]
  • The Medical Outcomes Study 36-Item Short -Form Health Survey Questionnaire (SF-36) [ Time Frame: Change from baseline in SF-36 at 6 weeks ] [ Designated as safety issue: No ]
  • Sciatica Frequency and Bothersome Index (SFBI) [ Time Frame: Change from baseline in SFBI at 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 324
Study Start Date: January 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
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 Name: 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 Name: Vitamin B1 or Thiamin or Thiamine or Aneurin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02087462

Contacts
Contact: Xi Wu, A.P. 86-15928830710 wuxi403@hotmail.com

Locations
China, Sichuan
Chengdu university of Traditonal Chinese Medcine Recruiting
Chengdu, Sichuan, China, 610075
Contact: Xi Wu, A.P.    86-15928830710    wuxi403@hotmail.com   
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         
Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Investigators
Study Director: Xi Wu, A.P. School of Acupunture& Tuina, Chengdu University of Traditional Chinese Medicine
  More Information

No publications provided

Responsible Party: Wu Xi, Principal Investigator, Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02087462     History of Changes
Other Study ID Numbers: 2011SZ0080
Study First Received: February 28, 2014
Last Updated: March 13, 2014
Health Authority: China: Ministry of Science and Technology

Keywords provided by Chengdu University of Traditional Chinese Medicine:
Sciatica
Electroacupuncture
Intervertebral disc displacement

Additional relevant MeSH terms:
Sciatica
Intervertebral Disk Displacement
Intervertebral Disk Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Diclofenac
Thiamine
Vitamin B Complex
Vitamins
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014