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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Low Back Pain, Pain, Postoperative, Failed Back Surgery Syndrome

Intervention / Treatment
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* Device: electroacupuncture and usual care
* Device: Usual care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture and Usual care<br>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. | Device: electroacupuncture and usual care<br>* Electroacupuncture: Using 0.25 mm (diameter) X 0.40 mm (length) sized disposable stainless steel needles, electric stimulation will be applied with an electronic stimulator (ES-160, ITO co. LTD, Japan) 2 times/week × 4 weeks. Stimulation will be applied with the current in biphasic wave form. Acupuncture points are Jia-ji (Ex-B2, L3-L5; bilateral) as necessary points and reasonable points (according to decision of practitioner) as accessory points. Each session lasts 15 minutes. Usual care: Physical therapy and patient education will be performed 2 times per week for 4 weeks. ICT lasts 15 minutes and Hot or Ice pack lasts 10minutes. Doctors will educate patient physiology, pathology, and epidemiology of low back pain. And also suitable postures and exercises for low back pain will be educated.<br>|
| Active Comparator: usual care<br>15 minutes ICT, 10 minutes hot pack or ice pack and education of patients | Device: Usual care<br>* Usual care: Physical therapy and patient education will be performed 2 times per week for 4 weeks. ICT lasts 15 minutes and Hot or Ice pack lasts 10minutes. Doctors will educate patient physiology, pathology, and epidemiology of low back pain. And also suitable postures and exercises for low back pain will be educated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale |  | up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index |  | up to 4 months | 
| EuroQoL 5-Dimension Questionnaire |  | up to 4 months |