The Effectiveness of Graded Motor Imagery in Phantom Limb Pain in Amputee Patients (GraMI Protocol)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change from baseline phantom limb pain at 9 weeks post-intervention and 12 weeks follow-up
研究概览
简要总结
The International Association for the Study of Pain defines phantom limb pain (PLP) as that pain referred to a part of the body that has been previously removed as if it were still present. It affects between 55-80% of the population who has suffered an amputation, but not in the same frequency and intensity. Graded motor imagery (GMI) is a progressive, physiotherapeutic treatment modality developed to train and reorganize the brain based on three consecutive techniques: laterality recognition, motor imagery, and mirror therapy. The scientific evidence on the implementation of GMI in PLP is scarce, noting that there is no standardized way to use it in this patient profile. Therefore, the need is generated to develop and validate a GMI protocol to address the PLP and test its effectiveness.
The study hypothesis is that graded motor imagery is a conservative treatment method based on motor learning, neuroplasticity, and mirror neuron stimulation that may have positive effects in decreasing phantom limb pain in the amputated patient, and as a consequence, decrease the associated psychological factors and improve the quality of life and functionality of the person.
A randomized clinical trial will be performed with simple blinding, following the CONSORT guide for this type of study.
It will be carried out at the community level with supervision and follow-up by the principal investigator.
详细描述
The International Association for the Study of Pain defines phantom limb pain (PLP) as that pain referred to a part of the body that has been previously removed as if it were still present. It affects between 55-80% of the population who has suffered an amputation, but not in the same frequency and intensity. The persistence of this pain over time may decrease the person's quality of life. The main hypothesis is that after an amputation, maladaptive plasticity occurs at the level of the primary motor and sensory cortex, causing an incongruity of visual, motor and sensory information.
Graded motor imagery (GMI) is a progressive, physiotherapeutic treatment modality developed to train and reorganize the brain based on three consecutive techniques: laterality recognition, motor imagery, and mirror therapy. The scientific evidence on the implementation of GMI in PLP is scarce, noting that there is no standardized way to use it in this patient profile. Therefore, the need is generated to develop and validate a GMI protocol to address the PLP and test its effectiveness.
Therefore, at the beginning of this project, a systematic review was performed to know the effectiveness of the GMI, and the techniques that make it up, on the PLP of the amputated patient, and thus be able to design an GMI protocol based on scientific evidence. Subsequently, this protocol was validated through a group of international experts through a study with Delphi methodology, resulting in the GMI protocol called GraMI.
The GraMI protocol is easy to implement, allowing the patient to perform it autonomously at home with the follow-up of a professional. It is necessary to have a mirror box and a mobile application to be able to carry out the intervention. During the COVID-19 pandemic, many patients remained in their homes confined without being able to access their rehabilitation, which caused alterations in the quality of life, in the prescribed treatment and in the evolution of the symptoms. The promotion of the patient's self-care at home, enhances their active participation and the intensity of the intervention, so that greater benefits can be obtained and consequently improvement in the quality of life.
Objectives:
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
- Single (Outcomes Assessor)
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
- •People over the age
- •Amputation of a limb.
- •Minimum score of 3 on the VAS.
- •Under pharmacological treatment for pain
- •Pharmacologically stable.
- •Be discharged from hospital.
排除标准
- •Visual disturbances (hemianopia).
- •Significant neurological or cognitive disturbances (attention deficit, sensory aphasia).
- •Receive two of the three techniques that make up the GMI as treatment.
结局指标
主要结局
Change from baseline phantom limb pain at 9 weeks post-intervention and 12 weeks follow-up
时间窗: Post intervention (9 weeks) and 12 weeks follow-up
Assessed by Short Form McGill Pain Questionnaire. Assesses pain qualitatively and quantitatively, it is a self-testifying scale. It consists of 15 pain descriptors, of which 11 are sensitive categories and 4 affective. In addition, it contains an analog visual scale of pain. It is self-contesting and each descriptor has three columns (medium, moderate, severe), where the patient must mark the degree to which that descriptor persists in their pain, in case of not being present they can leave it blank. . Columns are categorized to be 0; no pain, 1; mig, 2; moderate, 3; severe. The higher the score the more pain it indicates
次要结局
- Change from baseline physcological aspects at 9 weeks post-intervention and 12 weeks follow-up(Post intervention (9 weeks) and 12 weeks follow-up)
- Change from quality of life at 9 weeks post-intervention and 12 weeks follow-up(Post intervention (9 weeks) and 12 weeks follow-up)
- Change from baseline functionality at 9 weeks post-intervention and 12 weeks follow-up(Post intervention (9 weeks) and 12 weeks follow-up)
研究者
Sandra Rierola Fochs
Physiotherapist
University of Vic - Central University of Catalonia