The Effectiveness of a Pain Neuroscience Education Program Compared to Conventional Treatment on Pain, Biopsychosocial Variables, and Functional Capacity in Adults With Cancer Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 8
- 主要终点
- Change in Visual Analog Scale-Pain (EVA)
研究概览
简要总结
IASP defines "pain" as "an unpleasant sensory and emotional experience associated with or resembling that associated with actual or potential tissue damage". In some patients, pain is one of the reasons they initially consult a doctor and will be strongly related to cancer itself, is connected to receiving the cancer diagnosis, and therefore may become an uncertain threat of disease recurrence in cancer survivors. Neuropathic pain is the most prevalent type of pain, but a mixed type of pain is also common, reflecting the complexity of the pain experience. There is increasing evidence in oncology that quality of life and survival are linked to early and effective palliative care, including pain management. Although improvements have been seen, undertreatment of pain remains a problem in a significant subset of cancer patients. Regarding the interventional options in cancer pain, multiple possibilities range from pharmacological modulation, the use of modalities or physical means, as well as the practice of physical exercise as a mechanism of pain modulation, which has been established according to the background grade of recommendation. Regarding education in neuroscience, this has gained momentum in chronic pain since previous interventions have generated recommendations to include neurocognitive interventions in pain processes. Therefore, it seeks to determine the effectiveness of a neuroscience education program compared to conventional treatment in adults with cancer pain in biopsychosocial variables.
详细描述
A parallel group randomized controlled clinical trial will be conducted during the months of November 2022 to December 2023. The proposed research will be a quantitative experimental design type controlled clinical trial following the SPIRIT guidelines for clinical trial protocols and CONSORT for the execution of clinical trials.
A total of 80 patients, where 40 will be assigned to (PNE) and 40 to conventional management. experimental group: based on education in neuroscience of pain for 9 sessions in a period of 10 weeks. Work will be done to prepare the content for an adapted and illustrated guide as a complementary material for patients. An expert judgment test will be carried out to validate the content of the material. Each patient must complete at least 8 sessions to comply with the protocol. These sessions will be personalized and will include the guide as complementary material for each session. This group remains with pharmacological treatment and the usual guidelines given by the doctor. Results will be assessed at baseline (t1) and at week 10 (t2). Written informed consent will be obtained from all participants prior to their participation.
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 (Investigator, Outcomes Assessor)
盲法说明
Simple (result evaluator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a life expectancy of more than three months (Karnofski Scales (KPS), Eastern Cooperative Oncology Group Scale (ECOG), survival prognosis PAP score, Palliative Prognosis Index PPI).
- •Acceptance of informed consent.
- •Educational level (high school diploma).
- •No pain hospitalizations in the previous month
- •Capable of establishing a team communication process
- •at least 21 points on the MOCA scale for preserved cognitive function
- •Understanding of the Spanish language.
排除标准
- •Surgery scheduled within the next three months
- •Visual and auditory sensory system deficiency (deafness or blindness).
- •The presence of a recent traumatic injury
- •Atrial or ventricular arrhythmias that are uncontrolled.
- •Aortic aneurysm dissection
- •Aortic stenosis severe
- •Endocarditis or pericarditis that is acute
- •Uncontrollable hypertension
- •Thromboembolic disease, acute.
- •Acute severe heart failure
- •Acute severe respiratory failure
- •Fracture within the last month
结局指标
主要结局
Change in Visual Analog Scale-Pain (EVA)
时间窗: At baseline and through intervention's completion, 10 weeks
The severity of the pain at rest was assessed on a 10 cm visual analog scale (Total score: 0-10)(0=no pain, 10=severe pain) Higher scores mean a worse outcome.
Change in Brief Pain Inventory (Impact of pain)
时间窗: At baseline and through intervention's completion, 10 weeks
The BPI or brief pain questionnaire is a self-administered questionnaire that contains two dimensions: one related to the intensity of pain and the impact of pain on the activities of the patient's life. Its use has increased in the evaluation of patients with cancer pain. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. the higher the score, the greater the severity of the pain.
次要结局
- Change in DN4 neuropathic pain(At baseline and through intervention's completion, 10 weeks)
- Change in Moca test Cognitive function(At baseline and through intervention's completion, 10 weeks)
- Change in Beck Depression Inventory Score(At baseline and through intervention's completion, 10 weeks)
- Change in EORTC QLQ C-30 Quality of life(At baseline and through intervention's completion, 10 weeks)
- Change in Sleep quality Pittsburgh Sleep Quality Index(At baseline and through intervention's completion, 10 weeks)
- Change in Pain Catastrophizing Scale (PCS)(At baseline and through intervention's completion, 10 weeks)
- Change in Central Sensitization Inventory Score (CSI)(At baseline and through intervention's completion, 10 weeks)
- Change in Tampa Scale for Kinesiophobia (TSK-11)(At baseline and through intervention's completion, 10 weeks)