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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-02976 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (spinal cord stimulation, questionnaires) | Patients receiving spinal cord stimulation therapy complete questionnaires over 30 minutes at baseline and at 3, 6, and 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality-of-Life Assessment | Other | Complete quality of life assessment |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Percentage of patients who experience >= 50% improvement of pain intensity at 3 months and 12 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. SPSS software will be used for statistical analysis. | At 3 months and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients diagnosed with CIPN.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ryan S. D'Souza, MD | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Questionnaire Administration | Other | Complete questionnaires |
|
| Spinal Cord Stimulation | Procedure | Receive spinal cord stimulation therapy |
|
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| Neuropathy assessment | Assessed with Modified Toronto Clinical Neuropathic Pain Assessment performed by clinicians via a standardized neurological examination and scale. 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. SPSS software will be used for statistical analysis. | At baseline and 6 months |
| Neuropathic pain severity | Assessed with Neuropathy Pain Scale, a comprehensive questionnaire with 11 items assessing components of neuropathic pain. 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. SPSS software will be used for statistical analysis. | At baseline and 6 months |
| Perceived change/satisfaction | Patient Global Impression Scale reflects patient satisfaction and patient impression regarding the efficacy of the treatment or intervention. Graded on a 7-point scale. 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. SPSS software will be used for statistical analysis. | At baseline and 3, 6, and 12 months |
| Health-related quality of life | Assessed using the European Quality of Life Five Dimension Five Level Scale Questionnaire, a validated scale that measures domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. 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. SPSS software will be used for statistical analysis. | At baseline and 3, 6, and 12 months |
| Sleep issues | Assessed using the Medical Outcomes Study sleep scale, a 9-item questionnaire. Higher scores indicate poorer sleep quality. 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. SPSS software will be used for statistical analysis. | At baseline and 3, 6, and 12 months |
| Adverse events | 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. SPSS software will be used for statistical analysis. | At baseline and 3, 6, and 12 months |
| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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