. 2014 Dec 31;8:13–22. doi: 10.2147/IMCRJ.S73068

Table 1.

Inclusion and exclusion criteria

Inclusion criteria	Exclusion criteria
• Age ≥18 years • History of one or two anatomically successful lumbar spine surgeries for the treatment of low back pain • Pain in the low back and/or radiating to leg(s) at 3–36 months following surgery • Stable analgesic dosing regimen for ≥30 days • Mean pain intensity of 4 or greater (NPRS) in the subject’s low back or leg(s) during the study run-in phase • Willingness and ability to give written informed consent and to comply with all parts of the study protocol • Ability to read, understand, and follow study instructions • Ability to maintain a pain and symptom diary on a daily basis • For female subjects, be postmenopausal, surgically sterile, abstinent, or agree to practice an effective method of birth control for the duration of the study if sexually active	• More than two lumbar spine surgeries • Received any investigational drug or device within 30 days prior to study screening visit or is enrolled in another clinical trial • History of any uncontrolled medical illness or ongoing painful condition that, in the investigator’s judgment, places the subject at unacceptable risk • History of an ongoing painful condition that, in the investigator’s judgment, might have a confounding influence on safety and effectiveness analyses • Anticipated need for surgery of any type during the next 3 months • Serious psychosocial comorbidities • History of drug or alcohol abuse within 1 year prior to screening • History of malignancy within the past 5 years other than successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin and/or localized carcinoma in situ of the cervix • Implanted pacemaker, defibrillator, neurostimulator, spinal cord stimulator, bone stimulator, cochlear implant, or other implanted device with an implanted metal lead(s) • Existing or planned pregnancy • Previous treatment with the study device • In current litigation regarding back pain, or receiving Workers’ Compensation

Inclusion criteria

Exclusion criteria

• Age ≥18 years
• History of one or two anatomically successful lumbar spine surgeries for the treatment of low back pain
• Pain in the low back and/or radiating to leg(s) at 3–36 months following surgery
• Stable analgesic dosing regimen for ≥30 days
• Mean pain intensity of 4 or greater (NPRS) in the subject’s low back or leg(s) during the study run-in phase
• Willingness and ability to give written informed consent and to comply with all parts of the study protocol
• Ability to read, understand, and follow study instructions
• Ability to maintain a pain and symptom diary on a daily basis
• For female subjects, be postmenopausal, surgically sterile, abstinent, or agree to practice an effective method of birth control for the duration of the study if sexually active

• More than two lumbar spine surgeries
• Received any investigational drug or device within 30 days prior to study screening visit or is enrolled in another clinical trial
• History of any uncontrolled medical illness or ongoing painful condition that, in the investigator’s judgment, places the subject at unacceptable risk
• History of an ongoing painful condition that, in the investigator’s judgment, might have a confounding influence on safety and effectiveness analyses
• Anticipated need for surgery of any type during the next 3 months
• Serious psychosocial comorbidities
• History of drug or alcohol abuse within 1 year prior to screening
• History of malignancy within the past 5 years other than successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin and/or localized carcinoma in situ of the cervix
• Implanted pacemaker, defibrillator, neurostimulator, spinal cord stimulator, bone stimulator, cochlear implant, or other implanted device with an implanted metal lead(s)
• Existing or planned pregnancy
• Previous treatment with the study device
• In current litigation regarding back pain, or receiving Workers’ Compensation

Abbreviation: NPRS, numerical pain rating scale.