This study is a randomized controlled, assessor-blinded, multi-center trial, the participants of which are patients with recurring or persistent low back pain (with or without leg pain) after back surgery. The aim of this study is to evaluate the effectiveness and safety of electro-acupuncture in combination with usual care for patients with non-acute pain and dysfunction after back surgery.

Treatment

Participants will be randomly assigned to a treatment group or control group. Participants assigned to the treatment group will have electro-acupuncture twice a week during the four-week treatment period. Both groups will receive usual care management, including physical therapy and patient education, twice a week during the four-week treatment period.

Arm Label

Target Number of Participant

Arm Type

Arm Description

Participants in the usual care group will not receive electro-acupuncture treatment and will continue usual care management, including physical therapy and patient education, twice a week during the four-week treatment period.

Arm Label

Target Number of Participant

Arm Type

Arm Description

Participants assigned to the electro-acupuncture plus usual care group will receive electro-acupuncture and usual care management, including physical therapy and patient education, twice a week during the four-week treatment period.
Acupuncture points will include Jia-ji (Ex-B2, L3-L5; bilateral) as the required points, and other reasonable points can be chosen by the practitioner as accessory points. Electric stimulation will be applied with a frequency of 50 Hz (ES-160 electronic stimulator, ITO co. LTD, Japan). Each electro-acupuncture session will last 15 min.

Gender

Age

Description

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

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

Pain intensity scale: Visual Analogue Scale(VAS)

Every visit 

Functional scale: Oswestry Disability Index (ODI)

2, 4, 8 and 12 weeks after randomization  

Quality of life: EeroQol 5-Dimension (EQ-5D)

4, 8, 12 and 24 weeks after randomization  

Drug Consumption

Every visit 

Adverse events 

Every visit