Electroacupuncture for Sciatica Due to Intervertebral Disc Displacement

Chengdu University of Traditional Chinese Medicine

Status: Unknown

Conditions: Sciatica Due to Intervertebral Disc Disorder

Treatments: Drug: Voltaren; Other: Electroacupuncture (EA); Drug: Vitamin B1; Other: Traction

Study type: Interventional

Funder types: Other

Identifiers

NCT02087462

2011SZ0080

Details and patient eligibility

About

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.

Full 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.

Enrollment: 324 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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324 participants in 3 patient groups

Electroacupuncture (EA)

Experimental group

Description:

Use Electroacupuncture only

Treatment:

Other: Electroacupuncture (EA)

EA + Traction

Other group

Description:

Use electroacupuncture and traction together

Treatment:

Other: Electroacupuncture (EA)

Other: Traction

EA + Traction + Oral Medication

Other group

Description:

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

Treatment:

Other: Electroacupuncture (EA)

Drug: Vitamin B1

Other: Traction

Drug: Voltaren