An Integrative Medical Approach of Electroacupuncture with Usual care for Patients with Pain after Back surgery : A Multicenter, Randomized Controlled Clinical Trial, Qualitative and Cost-Effectiveness Research

Not Applicable

Recruiting

• Conditions: Not Applicable

• Registration Number: KCT0001939
• Lead Sponsor: Korea Institute of Oriental Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. Patients who are between 19 and 70 years of age
2. Patients whose low back pain persisted or recurred after back surgery with or without leg pain and patients whose pain has persisted for at least three weeks recently
3. Patients with pain, defined as a Visual Analogue Scale (VAS) value = 50mm
4. Patients who agreed to participate voluntarily in this study and signed a written informed consent forms

Exclusion Criteria

1. Patients who have been diagnosed with a serious disease that can cause low back pain (e.g., cancer, spinal infection, inflammatory spondylitis)
2. Patients with a progressive neurological deficit or with severe neurological symptoms
3. Patients whose pain causes are not resulted from spine or resulted from soft tissue diseases (e.g., cancer, fibromyalgia, rheumatoid arthritis, gout)
4. Patients with a chronic disease that could influence the treatment effects or the analysis of the treatment results (e.g., severe cardiovascular disease, diabetic neuropathy, dementia, epilepsy)
5. Patients for whom acupuncture would be inappropriate or unsafe (e.g., hemorrhagic disease, a history of having received anticoagulant therapy, severe diabetes with a risk of infection, severe cardiovascular disease)
6. Patients who are currently pregnant or planning to become pregnant
7. Patients with psychiatric diseases
8. Patients who are participating in another clinical trial
9. Patients who are unable to sign a written informed consent form
10. Patients who are judged by the researchers to be inappropriate for the clinical study

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain intensity scale: Visual Analogue Scale(VAS)

Secondary Outcome Measures

Name	Time	Method
Functional scale: Oswestry Disability Index (ODI);Quality of life: EeroQol 5-Dimension (EQ-5D);Drug Consumption;Adverse events