Graded Motor Imagery (GRAMI Protocol) for Phantom Limb Pain: A Randomised Clinical Trial of Home-Based Intervention

Abstract

Background: Phantom limb pain (PLP) affects 64% of individuals who have undergone amputation. Various theories explain its development, leading to different treatments, including graded motor imagery. This study analyses the effectiveness of a home-based intervention protocol based on graded motor imagery (GraMI protocol) as a treatment for phantom limb pain. Methods: A randomised, controlled, home-based, assessor-blinded clinical trial was conducted on individuals over 18 years old, with limb amputation, pharmacologically stable and discharged home. Participants followed the GraMI protocol or continued their current treatment for 9 weeks. Assessments were conducted at baseline, postintervention and at 3 months follow-up, evaluating PLP, quality of life, functionality and depressive symptoms. Results: The study enrolled 36 participants (mean age of 58.5 years), including 27 individuals with lower limb amputation and nine with upper limb amputation. Vascular issues were the primary cause, and 17 participants experienced preamputation pain. None of the participants in the control group received any PLP treatment during the study. Compliance with treatment among participants in the experimental group during the laterality recognition and explicit motor imagery phases was satisfactory, averaging 91.4%. Significant differences were found between groups in PLP (p = 0.02), persisting 12 weeks postintervention (p = 0.05). Within-group analysis revealed clinically significant PLP improvements postintervention (p = 0.003), and these improvements remained statistically significant 12 weeks later (p = 0.006). There were no statistically significant differences observed in the rest of the variables. Conclusion: The GraMI protocol shows effectiveness in reducing PLP in individuals who have undergone amputation, with this effect persisting 12 weeks after the intervention. Significance Statement: Phantom limb pain significantly impacts individuals with amputations, yet effective treatments remain limited. This study is crucial as it evaluates a home-based graded motor imagery (GraMI) protocol, offering a noninvasive, accessible intervention. The randomised clinical trial demonstrates GraMI's effectiveness in reducing PLP, with lasting effects up to 12 weeks. By addressing PLP, this research contributes to improving patients' quality of life, functionality and psychological well-being. Its findings support integrating GraMI into rehabilitation programs, providing evidence for a cost-effective, home-based therapeutic option. Trial Registration: ClinicalTrials.gov identifier: NCT05083611.