Effect of Graded Motor Imagery on Quality of Life, Pain, Kinesiophobia and Pain Catastrophization in Painful Diabetic Neuropathy: Study Protocol for 3-Arm Randomized Controlled Trial.

Background: Painful Diabetic Neuropathy (PDN) occurs as a complication in 88% of all patients with diabetic peripheral neuropathy. The intensity of pain has a direct impact on the function, levels of anxiety, kinesiophobia, fear of pain and fear of hypoglycemia, leading to reduction in the levels of physical activity.
Objective: The objective of this study will be to study the effects of Graded Motor Imagery (GMI), Graded exposure and Conventional Therapy on Quality of Life (QoL), pain, kinesiophobia, pain catastrophization and anxiety in participants with PDN.
Methods: This RCT will have three parallel groups with 30 participants in each group, calculated assuming partial eta squared value of 0.14, effect size of 0.403 at 85% power of the study and α error of 0.05 using G-power software.
Setting: The study will be conducted at OPD & IPD of a Tertiary Care Hospital in Goa-India.
Participants: Participants with Type 1 or Type II diabetes in the age group of 18-75 years having a score of 3 or more on DN-4 will be included in the study.
Intervention: Group A will receive GMI, Group B will be given graded exposure & group C will be undergoing conventional physical therapy treatment. The intervention will last for 8 weeks and follow-up will be done after one month. Primary Outcome Measure: assessment using RAND SF-36, Visual Analogue Scale, Tampa Scale for Kinesiophobia and Pain catastrophization will be done at 3 time points.
Conclusion: This high quality RCT will provide important information about the efficacy of GMI on QoL, pain levels, pain catastrophization, kinesiophobia and anxiety. It will provide evidence for the use of cognitive intervention for pain and its associated factors, consistent with the biopsychosocial model of pain.