Clinical trial NCT01966250: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Pain, Postoperative
Failed Back Surgery Syndrome
Lead sponsor: Korean Medicine Hospital of Pusan National University
Sponsor class: OTHER
First posted: 2013-10-21
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: up to 4 months
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: up to 4 months
measure: EuroQoL 5-Dimension Questionnaire
timeFrame: up to 4 months
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Korean Medicine Hospital
state: Gyeongsangnamdo
Study officials:
affiliation: Pusan National University Korean Medicine Hospital
name: Byung-cheul Shin
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.