Feasibility and Effectiveness of Repetitive Transcranial Magnetic Stimulation in Patients With Cancer Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Brief Pain Inventory, BPI
研究概览
简要总结
Over half of cancer patients experience cancer-related pain. Despite advances in pain management with opioids, many patients continue to suffer from chronic cancer pain. The underlying mechanisms of cancer-related pain remain poorly understood, but they may be linked to brain neuroplasticity. As a result, some researchers suggest that targeting the motor cortex in cancer patients could improve pain management. However, few studies have investigated the effectiveness of remodeling neuroplasticity with repetitive transcranial magnetic stimulation (rTMS) to reduce cancer-related pain. To validate the use of rTMS in cancer-related pain, we plan to conduct a randomized controlled trial involving 30 cancer pain patients. Participants will be randomly assigned to receive either rTMS or sham rTMS treatment. Functional magnetic resonance imaging (fMRI) and pain index assessments will be conducted before and after the treatment to evaluate the outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have cancer pain symptoms, confirmed by a physician as cancer pain or neuropathic cancer pain
- •Experienced the worst pain NRS score ≥ 4
- •The patient demonstrate good cognition and is able to cooperate with the assessment of pain severity.
- •The estimated survival time exceeds 3 months.
- •Pre-existing bisphosphonate, chemotherapy, and hormonal therapy regimens remained unchanged throughout the study.
排除标准
- •Individuals who have undergone head surgery or have metal implants in the head.
- •Individuals with implanted cardiac pacemakers or cochlear prostheses.
- •Have a history of epilepsy.
- •Patients diagnosed with primary brain tumors or metastatic brain lesions.
- •Present with additional neurological, psychiatric, or severe medical disorders.
- •Individuals with metallic implants located in the cranial or cervical regions.
- •Women who are pregnant.
- •Presence of acute pain in any body region attributable to other medical conditions. -
结局指标
主要结局
Brief Pain Inventory, BPI
时间窗: Assess the BPI outcome before the intervention, after 1 week and 2 weeks of intervention, as well as 1 week and 4 weeks after the intervention is completed.
BPI is to assess the severity of pain and the impact of pain on daily functions, including Severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours.
McGill Pain Questionnaire
时间窗: Assess MPQ scores before the intervention, after 1 week and 2 weeks of intervention, as well as 1 week and 4 weeks after the intervention is completed.
The McGill Pain Questionnaire (MPQ) is a self-report measure used by patients with various diagnoses to assess pain. It consists of 78 words, from which respondents select those that best describe their pain experience. The words are categorized as follows: Dimensions 1 to 10 (pain descriptors): 3 words Dimensions 11 to 15 (affective components of pain): 3 words Dimension 16 (evaluation of pain): 1 word Dimensions 17 to 20 (miscellaneous): 1 word. Scores are calculated by summing the values associated with each selected word, with scores ranging from 0 (no pain) to 78 (severe pain). Qualitative differences in pain are reflected in the respondent's word choices.
次要结局
- Numerical Rating Scale, NRS(Assess the NRS scale before the intervention, after 1 week and 2 weeks of intervention, as well as 1 week and 4 weeks after the intervention is completed.)
- Visual Analogue Scale , VAS(Assess the VAS scale before the intervention, after 1 week and 2 weeks of intervention, as well as 1 week and 4 weeks after the intervention is completed.)
- Resting-state functional imaging, rsfMRI(Assess the fMRI results before the intervention and after 2 weeks of interventions.)
- Beck Depression Inventory, BDI(Assess the BDI scale before the intervention, after 1 week and 2 weeks of intervention, as well as 1 week and 4 weeks after the intervention is completed.)
- The 36-Item Short Form Survey quality of life(Assess the The SF-36 outcome before the intervention, after 1 week and 2 weeks of intervention, as well as 1 week and 4 weeks after the intervention is completed.)