Electroacupuncture as a Complement to Usual Care for Patients With Non-acute Pain After Back Surgery: a Study Protocol for a Pilot Randomized Controlled Trial

Korean Medicine Hospital of Pusan National University1 site in 1 country40 target enrollmentOctober 2013

ConditionsLow Back Pain Pain, Postoperative Failed Back Surgery Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Low Back Pain
Sponsor: Korean Medicine Hospital of Pusan National University
Enrollment: 40
Locations: 1
Primary Endpoint: Visual Analogue Scale
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

March 2015

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Korean Medicine Hospital of Pusan National University

Responsible Party

Principal Investigator

Byung-Cheul Shin

associate professor

Korean Medicine Hospital of Pusan National University

Eligibility Criteria

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.