Effectiveness of an E-Health System Integrated in a Physical Recovery Program for the Treatment of Pain in the Oncological Population. PaiNEd Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change from baseline in Pain on the Visual Analogue scale and Brief Pain Inventory at 2 and 6 months.
研究概览
简要总结
The objectives of this study are: 1) To design and implement the PaiNEd system for the evaluation and treatment based on Pain Neuroscience Education (PNE) in cancer survivors with sequelae derived from medical treatments; 2) Study the effectiveness of the PaiNEd system integrated in a multimodal physical recovery program compared to traditional biomedical information.
This project aims to first carry out the design and implementation of an e-health system for the evaluation and treatment of pain. A randomized controlled experimental study will be carried out in which 72 breast cancer survivors will be recruited and randomly assigned to three study groups.
详细描述
People who have suffered cancer often do not find an adequate therapeutic response for the sequelae derived from its treatments. The objectives of this study are: 1) To design and implement the PaiNEd system for the evaluation and treatment based on Pain Neuroscience Education (PNE) in cancer survivors with sequelae derived from medical treatments; 2) Study the effectiveness of the PaiNEd system integrated in a multimodal physical recovery program compared to traditional biomedical information. In this regard, there is a shortage of proposals for certain subgroups of patients who demand special attention. This project aims to first carry out the design and implementation of an e-health system for the evaluation and treatment of pain. A randomized controlled experimental study will be carried out in which 72 breast cancer survivors will be recruited and randomly assigned to the three study groups: a) physical recovery program + access to the PaiNEd system; b) physical recovery program + traditional biomedical recommendations; c) control group. The evaluation will be carried out at baseline (at the beginning of the study), at 8 weeks (time of completion of the intervention) and at 6 months of follow-up of the patients.
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, Care Provider)
盲法说明
Participants who meet the inclusion criteria will be randomized into each of the groups using a random number generation program (EPIDAT 4.2, junta de Galicia). The sequence will be placed in an opaque envelope closed by a member outside the investigation and will be opened once the baseline assessment is completed, so the assessment staff will be masked for the randomization of the participants, thus reducing the risk of bias during the evaluation. The blinding of evaluators will be guaranteed by the fact that some members of the group are specialized in the treatment of cancer patients and others in their evaluation.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects over 18 years of age.
- •Having undergone surgery and finished adjuvant treatment (radiotherapy and / or chemotherapy) six months or two years ago.
- •Not having active cancer.
- •Having pain in the regions related to the tumor area (cervical and / or brachial and / or shoulder), pain ≥ 4 (VAS 0 to 10) for> 4 weeks
- •Present musculoskeletal or functional alterations in the previous regions.
排除标准
- •Identification by the research team of physical or mental impossibility to carry out the tests of the study.
- •Suffering from chronic pain or having suffered a previous trauma to the spine, head, temporomandibular joint or upper extremities.
结局指标
主要结局
Change from baseline in Pain on the Visual Analogue scale and Brief Pain Inventory at 2 and 6 months.
时间窗: Baseline, 2 and 6 months.
The Visual Analogue Scale is used to assess the intensity of spontaneous neck, temporomandibular and shoulder pain. The VAS is a 100 mm line anchored with a '0' at one end representing no pain and '100' at the other end representing the worst pain imaginable.
次要结局
- Changes from baseline in Pain Catastrophizing Scale at 2 and 6 months.(Baseline, 2 and 6 months.)
- Changes from baseline in Kinesiophobia on the Tampa Scale for Kinesiophobia (TSK-11) at 2 and 6 months.(Baseline, 2 and 6 months.)
- Changes from baseline in Isometric handgrip strength on Hand-held Dynamometry at 2 and 6 months.(Baseline, 2 and 6 months.)
- Changes from baseline in Body composition by using electrical bioimpedance analysis at 2 and 6 months.(Baseline, 2 and 6 months.)
- Changes from baseline in Central Sensitization Inventory (CSI) at 2 and 6 months.(Baseline, 2 and 6 months.)
- Changes from baseline in Active shoulder and cervical spine on goniometry at 2 and 6 months.(Baseline, 2 and 6 months.)
- Changes from baseline in Functional capacity on the The Six-Minute Walk Test at 2 and 6 months.(Baseline, 2 and 6 months.)
- Changes from baseline in stress and inflammatory responses at 2 and 6 months.(Baseline, 2 and 6 months.)
- Changes from baseline in Quality of life on The European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire at 2 and 6 months.(Baseline, 2 and 6 months.)
- Changes from baseline in Strength endurance deep cervical musculature on cranio-cervical flexion test at 2 and 6 months.(Baseline, 2 and 6 months.)
研究者
Carolina Fernández Lao
Principal Investigator
Universidad de Granada