- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01966250
Electroacupuncture as a Complement to Usual Care for Patients With Non-acute Pain After Back Surgery
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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gyeongsangnamdo
-
Yangsan, Gyeongsangnamdo, Korea, Republic of, 626-770
- Pusan National University Korean Medicine Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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. |
Active Comparator: usual care
15 minutes ICT, 10 minutes hot pack or ice pack and education of patients
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual Analogue Scale
Time Frame: up to 4 months
|
up to 4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Oswestry Disability Index
Time Frame: up to 4 months
|
up to 4 months
|
EuroQoL 5-Dimension Questionnaire
Time Frame: up to 4 months
|
up to 4 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Byung-cheul Shin, Pusan National University Korean Medicine Hospital
Publications and helpful links
General Publications
- Heo I, Hwang MS, Hwang EH, Cho JH, Ha IH, Shin KM, Lee JH, Kim NK, Son DW, Shin BC. Electroacupuncture as a complement to usual care for patients with non-acute low back pain after back surgery: a pilot randomised controlled trial. BMJ Open. 2018 May 17;8(5):e018464. doi: 10.1136/bmjopen-2017-018464.
- Hwang MS, Heo KH, Cho HW, Shin BC, Lee HY, Heo I, Kim NK, Choi BK, Son DW, Hwang EH. Electroacupuncture as a complement to usual care for patients with non-acute pain after back surgery: a study protocol for a pilot randomised controlled trial. BMJ Open. 2015 Feb 4;5(2):e007031. doi: 10.1136/bmjopen-2014-007031.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013012
- K13273 (Other Grant/Funding Number: Korea Institute of Oriental Medicine)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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