A Prospective Observational Study Assessing Efficacy of 10-kHz Spinal Cord Stimulation for the Treatment of Chemotherapy-Induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 cord tumor, central deafferentation syndrome, complex regional pain syndrome, acute herniating disc, severe spinal stenosis)
- •Certain comorbidities: coagulation/bleeding disorders, diminished capacity from cardiac/pulmonary disease
- •Obtaining another interventional procedure unrelated to SCS to treat limb pain
- •Have ongoing metastatic malignant neoplasm or untreated local malignant neoplasm. Included patients must be deemed as in remission per discretion of treating oncologist
- •Have a life expectancy of less than one year
- •Have untreated addiction or dependency to medications, alcohol, or illicit drugs
- •Have active, disruptive, and/or unstable psychological or psychiatric disorder
研究组 & 干预措施
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Spinal Cord Stimulation (Procedure)
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.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Pain intensity
时间窗: 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.
次要结局
- Sleep issues(At baseline and 3, 6, and 12 months)
- Adverse events(At baseline and 3, 6, and 12 months)
- Pain intensity(At 3 months and 12 months)
- Neuropathic pain severity(At baseline and 6 months)
- Perceived change/satisfaction(At baseline and 3, 6, and 12 months)
- Neuropathy assessment(At baseline and 6 months)
- Health-related quality of life(At baseline and 3, 6, and 12 months)