Effectiveness of graded motor imagery protocol in phantom limb pain in amputed patient: Protocol of a randomized clinical trial

Abstract

Objective: The aim of this study is to analyse the effectiveness of the Graded Motor Imagery (GraMI) protocol in phantom limb pain in amputee patients.

Materials and methods: A randomised clinical trial will be conducted, with two parallel groups and simple blinding, and a phenomenological study with semi-structured interviews. People over the age of 18, with amputation of one limb, with a minimum score of 3 on the visual analogue scale of pain, who are pharmacologically stable and have been discharged from hospital, will be recruited. An initial assessment, a post-intervention assessment (9 weeks) and a follow-up assessment (12 weeks post-intervention) will be performed, in which pain, quality of life, functionality and psychological aspects will be assessed. The aim of the qualitative study is to find out about the experience of living with phantom limb pain and to identify the satisfaction with the intervention. A descriptive, univariate and bivariate quantitative statistical analysis will be performed using the SPSS program, with a 95% confidence level and a statistical significance level of p < 0.05. The qualitative analysis will be carried out using the Atlas.ti 8.0 program, where the different interviews will be analysed, coded and categorised.

Discussion: The GraMI protocol allows the patient to work on motor learning through brain reorganisation, analytical movements, sensory stimulation, and functional activities. In addition, it can help to standardise the use of graded motor imagery in future studies and in clinical practice with this patient profile.

Trial registration: NCT05083611.

Fig 1. Outlines when each study component occurs in accordance with the SPIRIT guidelines.

SF-MPQ: Short form McGill Pain Questionnaire, EQ-5D-5L: EuroQool-5D-5l, FIM: Functional Independence Measure, Beck: Inventario de depresión de Beck, t: Timepoint, GraMI: Graded motor imagery.

Fig 2. Progression of the images during the three weeks in the phase of laterality recognition and motor imagery.

First week: Images in neutral positions in the different planes (left), second week: Images in different positions in the different planes (centre), third week: Images of functional activities or with object interaction (right).

Fig 3. Progression of the images during the three weeks in the phase of mirror therapy.

First week: Analytical movements of the joints involved in the amputation (left), second week: Sensory stimulation with different temperatures, textures, densities and/or vibration (centre), third week: Interaction between objects or functional activities (right).