Assessing Effect of Spinal Cord Stimulation on Pain and Quality of Life With Chemotherapy-Induced… (NCT05411523) | Clinical Trial Compass
RecruitingNot Applicable
Assessing Effect of Spinal Cord Stimulation on Pain and Quality of Life With Chemotherapy-Induced Peripheral Neuropathy
United States20 participantsStarted 2022-04-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.