Graded Motor Imagery in Phantom Limb Pain (GraMI Protocol) (GraMI)

January 30, 2024 updated by: Sandra Rierola Fochs, University of Vic - Central University of Catalonia

The Effectiveness of Graded Motor Imagery in Phantom Limb Pain in Amputee Patients (GraMI Protocol)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Catalunya
      • Vic, Catalunya, Spain, 08500
        • Sandra Rierola Fochs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
The control group will receive an information session on phantom limb pain (1 hour) and will continue with the usual treatment received.
Experimental: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline phantom limb pain at 9 weeks post-intervention and 12 weeks follow-up
Time Frame: 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
Post intervention (9 weeks) and 12 weeks follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from quality of life at 9 weeks post-intervention and 12 weeks follow-up
Time Frame: Post intervention (9 weeks) and 12 weeks follow-up
Assessed by EuroQol scale. It is a self-challenging scale made up of 5 dimensions: mobility, self-care, regular activities, pain / discomfort and anxiety / depression. Each dimension has 5 levels: no problems, mild, moderate, severe and extreme problems. The patient is asked to indicate his / her state of health by ticking the box together with the most appropriate statement in each of the 5 dimensions. In addition, it contains a numerical scale from 0 to 100 to quantify the degree of health status on the day of assessment.
Post intervention (9 weeks) and 12 weeks follow-up
Change from baseline functionality at 9 weeks post-intervention and 12 weeks follow-up
Time Frame: Post intervention (9 weeks) and 12 weeks follow-up

Assessed by Functional Independence Scale (FIM). It is a scale built from 18 items within 6 areas of operation: personal care, sphincter control, mobility, walking, communication and social knowledge.

The maximum score for each item is 7 and the minimum is 1.
Post intervention (9 weeks) and 12 weeks follow-up
Change from baseline physcological aspects at 9 weeks post-intervention and 12 weeks follow-up
Time Frame: Post intervention (9 weeks) and 12 weeks follow-up
Assessed by Beck depression inventory. It is a self-answering scale of 21 questions. Each question is graded on a 4-point scale ranging from 0 to 3, with 0 experiencing no symptoms and 3 experiencing symptoms severely.
Post intervention (9 weeks) and 12 weeks follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vic - Central University of Catalonia

Investigators

  • Principal Investigator: Sandra Rierola Fochs, Universitat de Vic- Universitat Central de Catalunya (UVic-UCC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2023

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

October 1, 2021

First Submitted That Met QC Criteria

October 15, 2021

First Posted (Actual)

October 19, 2021

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTGraMI01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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