Electroacupuncture as a Complement to Usual Care for Patients With Non-acute Pain After Back Surgery

Not Applicable

Completed

• Conditions: Failed Back Surgery Syndrome; Low Back Pain; Pain, Postoperative
• Interventions: Device: electroacupuncture and usual care; Device: Usual care

• Registration Number: NCT01966250
• Lead Sponsor: Korean Medicine Hospital of Pusan National University

Brief Summary

The purpose of this study is to find out the effectiveness of integrative medicine model for pain relief and improvement of function and quality of life on the patients with pain after back surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-11
• Study First Submitted QC: 2013-10-16
• Study First Posted: 2013-10-21
• Primary Completion: 2015-01
• Status Verified: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients whose low back pain persisted or recurred after back surgery with or without leg pain.
• Patients whose pain has been persisted at least 3 weeks recently and who are necessary to care intermittent medical treatments (eg. medication, injection, physio therapy).
• Patients with pain, defined as an Visual Analogue Scale (VAS) value ≥ 50mm.
• Patients who are 19 - 70 years of age.
• Patients who agreed to voluntarily participate in this study and signed informed consent.

Exclusion Criteria

• Patients who have been diagnosed with a serious disease that can cause low back pain (e.g., cancer, vertebral fracture, spinal infection, inflammatory spondylitis, cauda equine compression, or other disqualifying conditions).
• Patients with progressive neurological deficit or severe neurological symptoms.
• Patients whose pain causes are not resulted from spine or resulted from soft tissue diseases(e.g., cancer, fibromyalgia, rheumatoid arthritis, gout).
• Patients with a chronic disease that could influences the effects of the treatment or the analysis of treatment results (e.g., cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, dementia, epilepsy, or other disqualifying conditions).
• Patients for whom acupuncture would be inappropriate or unsafe (e.g., hemorrhagic disease, clotting disorders, a history of receiving anticoagulant therapy, severe diabetes with a risk of infection, severe cardiovascular disease, or other disqualifying conditions)
• Patients who are currently pregnant or planning the pregnancy.
• Patients with psychiatric diseases.
• Patients who are participating in other clinical trial.
• Patients who are unable to sign informed consent.
• Patients who are judged to be inappropriate for the clinical study by the researchers, such as inability to read and write Korean.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electroacupuncture and Usual care	electroacupuncture and usual care	15 minutes of electroacupuncture and usual care. Usual care contains 15 minutes ICT(Interferential Current Therapy), 10 minutes hot pack or ice pack and education of patients.
usual care	Usual care	15 minutes ICT, 10 minutes hot pack or ice pack and education of patients

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	up to 4 months

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Index	up to 4 months
EuroQoL 5-Dimension Questionnaire	up to 4 months

Trial Locations

Locations (1)

Pusan National University Korean Medicine Hospital; 🇰🇷 Yangsan, Gyeongsangnamdo, Korea, Republic of