Graded Motor Imagery in Phantom Limb Pain (GraMI Protocol)

NCT05083611 | Completed

• 1 other identifier: PTGraMI01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Phantom Limb Pain

Keywords

Phantom limb pain; Graded motor imagery; Treatment; Amputee

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

• Change from baseline physcological aspects at 9 weeks post-intervention and 12 weeks follow-up

  Post intervention (9 weeks) and 12 weeks follow-up

Study Arms (2)

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.

Other: GraMI

Interventions

GraMI 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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Vic - Central University of Catalonia: lead

Study Sites (1)

Sandra Rierola Fochs

Vic, Catalonia, 08500, Spain

Location

Related Publications (6)

• 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.

  PMID: 30762318 BACKGROUND

• 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.

  PMID: 27582042 BACKGROUND

• 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.

  PMID: 17082465 BACKGROUND

• 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.

  PMID: 31992445 BACKGROUND

• Rierola-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.

  PMID: 41255083 DERIVED

• 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.

  PMID: 36006951 DERIVED

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Sandra Rierola Fochs

  Universitat de Vic- Universitat Central de Catalunya (UVic-UCC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 19, 2021
• Study Start: January 15, 2023
• Primary Completion: July 31, 2023
• Study Completion: November 30, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

ES (1)