Assessing Effect of Spinal Cord Stimulation on Pain and Quality of Life With Chemotherapy-Induced Peripheral Neuropathy

PRIMARY OBJECTIVES:

I. To measure percentage of responders who had at least 50% reduction in lower extremity pain at 6 months.

II. To measure overall improvement in neurological assessment at 6 months. III. To measure secondary metrics including change in perceived global change/satisfaction, health-related quality of life, and sleep disturbance.

IV. To determine if there are any significant adverse events encountered with spinal cord stimulation (SCS) therapy for cancer-related pain.

OUTLINE:

Patients receiving spinal cord stimulation therapy complete questionnaires over 30 minutes at baseline and at 3, 6, and 12 months.

Inclusion criteria

• Adult patients greater than or equal to 18 years of age who have been clinically diagnosed with CIPN for greater than six months after stopping chemotherapy
• Average pain intensity >= 5 on 11-point numeric rating scale (NRS) in the lower extremities at enrollment
• Failed conventional medication management with at least two neuropathic pain medications
• Have electrophysiological evidence of length-dependent peripheral neuropathy
• Underwent a 10-kHz spinal cord stimulator trial for a primary indication of CIPN and reported a successful trial of at least 75% reduction in pain intensity
• Have stable neurological status
• Be on a stable analgesic regimen
• Be an appropriate candidate for surgical procedures required in this study
• Be able to read and understand English-written questionnaires and sign an informed consent form in English
• Be willing and capable of giving informed consent
• Be willing and able to complete study-related requirements, procedures, and visits

Exclusion criteria

• Patient refusal to be included in study
• Presence of lower limb mononeuropathy
• History of lower limb amputation or ulceration
• Presence of another painful condition that is unrelated to CIPN and that is not intended to be treated in this study
• Body mass index (BMI) >= 40
• Omeprazole (OME) > 120 mg
• Progressive neurological disease (multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, complex regional pain syndrome, acute herniating disc, severe spinal stenosis)
• Certain comorbidities: coagulation/bleeding disorders, diminished capacity from cardiac/pulmonary disease
• Obtaining another interventional procedure unrelated to SCS to treat limb pain
• Have ongoing metastatic malignant neoplasm or untreated local malignant neoplasm. Included patients must be deemed as in remission per discretion of treating oncologist
• Have a life expectancy of less than one year
• Have untreated addiction or dependency to medications, alcohol, or illicit drugs
• Have active, disruptive, and/or unstable psychological or psychiatric disorder