Phantom Limb PainGraMINCT05083611
Graded Motor Imagery in Phantom Limb Pain (GraMI Protocol)
A study testing GraMI in people with Phantom Limb Pain, run by University of Vic - Central University of Catalonia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phantom Limb Pain
- What is being tested?
- GraMI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Phantom Limb Pain
- Being tested
- GraMI
- Keywords
- Phantom limb pain, Graded motor imagery, Treatment, Amputee
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GraMIOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group will receive an information session on phantom limb pain (1 hour) and will continue with the usual treatment received. |
| Experimental group | Experimental | 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. Receives: Other: GraMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Post intervention (9 weeks) and 12 weeks follow-up
Secondary outcomes (3)
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.
Measured: Post intervention (9 weeks) and 12 weeks follow-up
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.
Measured: Post intervention (9 weeks) and 12 weeks follow-up
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.
Measured: Post intervention (9 weeks) and 12 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start15 Jan 2023
- Primary completion31 Jul 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Phantom Limb PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vic - Central University of Catalonia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Rierola Fochs, University of Vic - Central University of Catalonia
- Investigators
- Sandra Rierola Fochs, Principal investigator, Universitat de Vic- Universitat Central de Catalunya (UVic-UCC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083611
- Sponsor's protocol ID
- PTGraMI01
- Acronym
- GraMI
- Status last verified
- Jan 2024
- First submitted
- 1 Oct 2021
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30762318Limakatso 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.
PubMed 27582042Moseley 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.
PubMed 17082465Limakatso 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.
PubMed 31992445Rierola-Fochs S, Terradas-Monllor M, Grau-Carrion S, Ochandorena-Acha M, Minobes-Molina E, Merchan-Baeza JA. Graded Motor Imagery (GRAMI Protocol) for Phantom Limb Pain: A Randomised Clinical Trial of Home-Based Intervention. Eur J Pain. 2026 Jan;30(1):e70167. doi: 10.1002/ejp.70167.
PubMed 41255083Rierola-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.
PubMed 36006951
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Graded Motor Imagery in Phantom Limb Pain in Amputee Patients (GraMI Protocol)
- ClinicalTrials.gov ID
- NCT05083611
- Acronym / sponsor ID
- GraMI / PTGraMI01
- Conditions
- Phantom Limb Pain
- Keywords
- Phantom limb pain, Graded motor imagery, Treatment, Amputee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Vic - Central University of CataloniaUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group will receive an information session on phantom limb pain (1 hour) and will continue with the usual treatment received. |
| Experimental group | Experimental | Other: GraMIThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- People over the age 18.
- Amputation of a limb.
- Minimum score of 3 on the VAS.
- Under pharmacological treatment for pain
- Pharmacologically stable.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GraMIThe 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. | Other | Experimental group |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Background: PubMed 30762318Anaforoglu 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.
- Background: PubMed 27582042Limakatso 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.
- Background: PubMed 17082465Moseley 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.
- Background: PubMed 31992445Limakatso 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.
- Derived from this study: PubMed 41255083Rierola-Fochs S, Terradas-Monllor M, Grau-Carrion S, Ochandorena-Acha M, Minobes-Molina E, Merchan-Baeza JA. Graded Motor Imagery (GRAMI Protocol) for Phantom Limb Pain: A Randomised Clinical Trial of Home-Based Intervention. Eur J Pain. 2026 Jan;30(1):e70167. doi: 10.1002/ejp.70167.
- Derived from this study: PubMed 36006951Rierola-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Rierola Fochs principal investigator
Universitat de Vic- Universitat Central de Catalunya (UVic-UCC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GraMI in people with Phantom Limb Pain, run by University of Vic - Central University of Catalonia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05083611, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.