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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01966250
• Other study ID #: 2013012
• Secondary ID: K13273
• Status: Completed
• Phase: N/A
• First received: October 11, 2013
• Last updated: March 30, 2015
• Start date: October 2013
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Korean Medicine Hospital of Pusan National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug SafetyKorea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• electroacupuncture and usual care
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.
• Usual care
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.

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Korean Medicine Hospital	Yangsan	Gyeongsangnamdo

Sponsors (1)

Lead Sponsor	Collaborator
Korean Medicine Hospital of Pusan National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale		up to 4 months	No
Secondary	Oswestry Disability Index		up to 4 months	No
Secondary	EuroQoL 5-Dimension Questionnaire		up to 4 months	No