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

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

electroacupuncture and usual care

Usual care

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Pusan National University Korean Medicine Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electroacupuncture and Usual care

usual care

Arm Description

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.

15 minutes ICT, 10 minutes hot pack or ice pack and education of patients

Outcomes

Primary Outcome Measures

Visual Analogue Scale

Secondary Outcome Measures

Oswestry Disability Index

EuroQoL 5-Dimension Questionnaire

Full Information

NCT ID

NCT01966250

First Posted

October 11, 2013

Last Updated

March 30, 2015

Sponsor

Korean Medicine Hospital of Pusan National University

1. Study Identification

Unique Protocol Identification Number

NCT01966250

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Korean Medicine Hospital of Pusan National University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Electroacupuncture and Usual care

Arm Type

Experimental

Arm Description

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.

Arm Title

usual care

Arm Type

Active Comparator

Arm Description

15 minutes ICT, 10 minutes hot pack or ice pack and education of patients

Intervention Type

Device

Intervention Name(s)

electroacupuncture and usual care

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Usual care

Intervention Description

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.

Primary Outcome Measure Information:

Title

Visual Analogue Scale

Time Frame

up to 4 months

Secondary Outcome Measure Information:

Title

Oswestry Disability Index

Time Frame

up to 4 months

Title

EuroQoL 5-Dimension Questionnaire

Time Frame

up to 4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Byung-cheul Shin

Organizational Affiliation

Pusan National University Korean Medicine Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pusan National University Korean Medicine Hospital

City

Yangsan

State/Province

Gyeongsangnamdo

ZIP/Postal Code

626-770

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

29773696

Citation

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.

Results Reference

derived

PubMed Identifier

25652804

Citation

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.

Results Reference

derived

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

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