NCT05411523

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

A Prospective Observational Study Assessing Efficacy of 10-kHz Spinal Cord Stimulation for the Treatment of Chemotherapy-Induced Peripheral Neuropathy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chemotherapy-Induced Peripheral Neuropathy
• Hematopoietic and Lymphoid System Neoplasm
• Malignant Solid Neoplasm

Interventions

Type	Name	Description
OTHER	Quality-of-Life Assessment	Complete quality of life assessment
OTHER	Questionnaire Administration	Complete questionnaires
PROCEDURE	Spinal Cord Stimulation	Receive spinal cord stimulation therapy

Timeline

• Start date: 2022-04-14
• Primary completion: 2027-04-15
• Completion: 2027-04-15
• First posted: 2022-06-09
• Last updated: 2026-02-02

Locations

1 site across 1 country: United States