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

Primary Purpose

Phantom Limb Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GraMI
Sponsored by
University of Vic - Central University of Catalonia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Phantom Limb Pain focused on measuring Phantom limb pain, Graded motor imagery, Treatment, Amputee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control group

    Experimental group

    Arm Description

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

    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.

    Outcomes

    Primary Outcome Measures

    Change from baseline phantom limb pain at 9 weeks post-intervention 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

    Secondary Outcome Measures

    Change from quality of life at 9 weeks post-intervention 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.
    Change from baseline functionality at 9 weeks post-intervention 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.
    Change from baseline physcological aspects at 9 weeks post-intervention 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.

    Full Information

    First Posted
    October 1, 2021
    Last Updated
    June 15, 2022
    Sponsor
    University of Vic - Central University of Catalonia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05083611
    Brief Title
    Graded Motor Imagery in Phantom Limb Pain (GraMI Protocol)
    Acronym
    GraMI
    Official Title
    The Effectiveness of Graded Motor Imagery in Phantom Limb Pain in Amputee Patients (GraMI Protocol)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 15, 2022 (Anticipated)
    Primary Completion Date
    March 31, 2023 (Anticipated)
    Study Completion Date
    November 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Vic - Central University of Catalonia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Phantom Limb Pain
    Keywords
    Phantom limb pain, Graded motor imagery, Treatment, Amputee

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    The control group will receive an information session on phantom limb pain (1 hour) and will continue with the usual treatment received.
    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    GraMI
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change from baseline phantom limb pain at 9 weeks post-intervention and 12 weeks follow-up
    Description
    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
    Time Frame
    Post intervention (9 weeks) and 12 weeks follow-up
    Secondary Outcome Measure Information:
    Title
    Change from quality of life at 9 weeks post-intervention and 12 weeks follow-up
    Description
    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.
    Time Frame
    Post intervention (9 weeks) and 12 weeks follow-up
    Title
    Change from baseline functionality at 9 weeks post-intervention and 12 weeks follow-up
    Description
    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.
    Time Frame
    Post intervention (9 weeks) and 12 weeks follow-up
    Title
    Change from baseline physcological aspects at 9 weeks post-intervention and 12 weeks follow-up
    Description
    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.
    Time Frame
    Post intervention (9 weeks) and 12 weeks follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sandra Rierola Fochs
    Phone
    630841957
    Email
    sandra.rierola@uvic.cat
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sandra Rierola Fochs
    Organizational Affiliation
    Universitat de Vic- Universitat Central de Catalunya (UVic-UCC)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    30762318
    Citation
    Anaforoglu Kulunkoglu B, Erbahceci F, Alkan A. A comparison of the effects of mirror therapy and phantom exercises on phantom limb pain. Turk J Med Sci. 2019 Feb 11;49(1):101-109. doi: 10.3906/sag-1712-166.
    Results Reference
    background
    PubMed Identifier
    27582042
    Citation
    Limakatso K, Corten L, Parker R. The effects of graded motor imagery and its components on phantom limb pain and disability in upper and lower limb amputees: a systematic review protocol. Syst Rev. 2016 Sep 1;5(1):145. doi: 10.1186/s13643-016-0322-5.
    Results Reference
    background
    PubMed Identifier
    17082465
    Citation
    Moseley GL. Graded motor imagery for pathologic pain: a randomized controlled trial. Neurology. 2006 Dec 26;67(12):2129-34. doi: 10.1212/01.wnl.0000249112.56935.32. Epub 2006 Nov 2.
    Results Reference
    background
    PubMed Identifier
    31992445
    Citation
    Limakatso K, Madden VJ, Manie S, Parker R. The effectiveness of graded motor imagery for reducing phantom limb pain in amputees: a randomised controlled trial. Physiotherapy. 2020 Dec;109:65-74. doi: 10.1016/j.physio.2019.06.009. Epub 2019 Jun 28.
    Results Reference
    background
    PubMed Identifier
    36006951
    Citation
    Rierola-Fochs S, Merchan-Baeza JA, Minobes-Molina E. Effectiveness of graded motor imagery protocol in phantom limb pain in amputed patient: Protocol of a randomized clinical trial. PLoS One. 2022 Aug 25;17(8):e0273356. doi: 10.1371/journal.pone.0273356. eCollection 2022.
    Results Reference
    derived

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    Graded Motor Imagery in Phantom Limb Pain (GraMI Protocol)

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