Graded Motor Imagery in Phantom Limb Pain (GraMI Protocol)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-15

Study Completion Date

2023-11-30

Brief Summary

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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.

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Detailed Description

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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:

Main objective:

\- Study the effects of the GraMI protocol on DMF in the amputee patient.

Secondary objectives:

* Design a mobile application to be able to carry out the intervention and determine its usability.
* Analyse the effects of the GraMI protocol on the quality of life, functionality and psychological aspects of amputee patients.
* Understand the perception and satisfaction obtained through the intervention.

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.

During recruitment, a person outside the intervention will randomize the participants through sealed envelopes where they will be assigned to the control group or intervention group. A non-probabilistic sampling type for quotas will be used.

The intervention of the two groups will last 9 weeks plus 12 weeks of follow-up. During the study, three assessments will be performed, one at the beginning, one after the intervention (9 weeks) and one follow-up (12 weeks post-intervention).

These assessments will collect quantitative variables and also conduct semi-structured individual interviews with participants who are part of the intervention group in order to know and understand the influence of phantom limb pain in their lives and the degree of satisfaction obtained through the intervention.

Conditions

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Phantom Limb Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

The control group will receive an information session on phantom limb pain (1 hour) and will continue with the usual treatment received.

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental group

The experimental group will receive an educational session on phantom limb pain and the previously designed GraMI protocol through a systematic review and validation through a study with Delphi methodology. This protocol contains the three techniques with their defined intensity, frequency, duration and progression.

Group Type EXPERIMENTAL

GraMI

Intervention Type OTHER

The intervention will last 6 weeks. Each technique lasts for 2 weeks. The first two techniques will be performed through the previously designed mobile application and the last technique will be performed through a mirror box. The patient can do it autonomously with the supervision of the principal investigator.

Interventions

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GraMI

The intervention will last 6 weeks. Each technique lasts for 2 weeks. The first two techniques will be performed through the previously designed mobile application and the last technique will be performed through a mirror box. The patient can do it autonomously with the supervision of the principal investigator.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* People over the age 18.
* Amputation of a limb.
* Minimum score of 3 on the VAS.
* Under pharmacological treatment for pain
* Pharmacologically stable.
* Be discharged from hospital.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No