Assessing Effect of Spinal Cord Stimulation on Pain and Quality of Life in Patients With Chemotherapy-Induced Peripheral Neuropathy
Study Details
Study Description
Brief Summary
This study examines how spinal cord stimulation affects pain level and quality of life in patients experiencing chemotherapy-induced peripheral neuropathy (CIPN). CIPN is pain resulting from treatment with chemotherapy. Spinal cord stimulation is a type of therapy that can be used to treat cancer-related pain and may be useful in patients with CIPN. This study evaluates how spinal cord stimulation affects pain and quality of life in patients with CIPN.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
PRIMARY OBJECTIVES:
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To measure percentage of responders who had at least 50% reduction in lower extremity pain at 6 months.
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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.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Other: Quality-of-Life Assessment
Complete quality of life assessment
Other: Questionnaire Administration
Complete questionnaires
Procedure: Spinal Cord Stimulation
Receive spinal cord stimulation therapy
|
Outcome Measures
Primary Outcome Measures
- Pain intensity [At 6 months]
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.
Secondary Outcome Measures
- Pain intensity [At 3 months and 12 months]
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.
- Neuropathy assessment [At baseline and 6 months]
Assessed with Modified Toronto Clinical Neuropathic Pain Assessment (mTCNS) 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. mTCNS measure: a total score of 19, the grades are defined as follows: 0-5 = no neuropathy; 6-8 = mild neuropathy; 9-11 = moderate neuropathy; ≥ 12 = severe neuropathy.
- Neuropathic pain severity [At baseline and 6 months]
Assessed with Neuropathy Pain Scale, a comprehensive questionnaire with 11 items assessing components of neuropathic pain. Scores are based on patient responses to questions about pain intensity. 0 indicates no pain; 10 indicates the most pain imaginable. 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.
- Perceived change/satisfaction [At baseline and 3, 6, and 12 months]
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.
- Health-related quality of life [At baseline and 3, 6, and 12 months]
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. Scale of 0 = no problem to 5 = unable to do activities, severe pain and anxiety. 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.
- Sleep issues [At baseline and 3, 6, and 12 months]
Assessed using the Medical Outcomes Study sleep scale, a 9-item questionnaire with 1 measuring All of the Time to 1 measuring None of the Time. 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.
- Adverse events [At baseline and 3, 6, and 12 months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients aged 18 to 70 who have been clinically diagnosed with CIPN for greater than six months after stopping chemotherapy
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Average pain intensity >= 5 on 11-point numeric rating scale (NRS) in the lower extremities at enrollment
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Failed conventional medication management with at least two neuropathic pain medications
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Have electrophysiological evidence of length-dependent peripheral neuropathy
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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
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Have stable neurological status
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Be on a stable analgesic regimen
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Be an appropriate candidate for surgical procedures required in this study
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Be able to read and understand English-written questionnaires and sign an informed consent form in English
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Be willing and capable of giving informed consent
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Be willing and able to complete study-related requirements, procedures, and visits
Exclusion Criteria:
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Patient refusal to be included in study
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Presence of lower limb mononeuropathy
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History of lower limb amputation or ulceration
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Presence of another painful condition that is unrelated to CIPN and that is not intended to be treated in this study
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Body mass index (BMI) >= 40
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Omeprazole (OME) > 120 mg
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Progressive neurological disease (multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, complex regional pain syndrome, acute herniating disc, severe spinal stenosis)
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Certain comorbidities: coagulation/bleeding disorders, diminished capacity from cardiac/pulmonary disease
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Obtaining another interventional procedure unrelated to SCS to treat limb pain
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Have ongoing metastatic malignant neoplasm or untreated local malignant neoplasm. Included patients must be deemed as in remission per discretion of treating oncologist
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Have a life expectancy of less than one year
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Have untreated addiction or dependency to medications, alcohol, or illicit drugs
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Have active, disruptive, and/or unstable psychological or psychiatric disorder
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Ryan S D'Souza, Mayo Clinic in Rochester
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-001218
- NCI-2022-02976
- 22-001218
- P30CA015083