A Prospective Observational Study Assessing Efficacy of 10-kHz Spinal Cord Stimulation for the Treatment of Chemotherapy-Induced Peripheral Neuropathy
This study examines how spinal cord stimulation (SCS) affects pain level and quality of life in patients experiencing chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a nerve problem and one of the potential side effects of chemotherapy that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. CIPN usually begins in the hands or feet and gets worse over time. SCS is a type of therapy that has proven to be effective in treating numerous non-malignant pain disorders including failed back surgery syndrome, refractory angina, limb ischemia, complex regional pain syndrome, and diabetic peripheral neuropathy. SCS may also be useful in patients with CIPN. This study evaluates how SCS affects pain and quality of life in patients undergoing spinal cord stimulation for CIPN.
• 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