A Prospective Observational Study Assessing Efficacy of 10-kHz Spinal Cord Stimulation for the Treatment of Chemotherapy-Induced Peripheral Neuropathy
Summary
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.
Detailed description
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.
Arms & interventions
- OtherQuality-of-Life Assessment
Complete quality of life assessment
- OtherQuestionnaire Administration
Complete questionnaires
- ProcedureSpinal Cord Stimulation
Receive spinal cord stimulation therapy
Outcome measures
Primary
Pain intensity
Percentage of patients who experience \>= 50% improvement of pain intensity on numeric rating scale score at 6 months compared to baseline. Paired t-test test will be carried out to compare questionnaire scores between each follow-up time point and baseline. All p-values will be reported as two-sided. Statistical Packages for Social Sciences (SPSS) software will be used for statistical analysis.
Time frame: At 6 months
Secondary
Pain intensity
Time frame: At 3 months and 12 months
Neuropathy assessment
Time frame: At baseline and 6 months
Neuropathic pain severity
Time frame: At baseline and 6 months
Perceived change/satisfaction
Time frame: At baseline and 3, 6, and 12 months
Health-related quality of life
Time frame: At baseline and 3, 6, and 12 months
Sleep issues
Time frame: At baseline and 3, 6, and 12 months
Adverse events
Time frame: At baseline and 3, 6, and 12 months
Eligibility criteria
Study locations (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905