Effect of Pain Neuroscience Education versus Conventional Patient Education on Pain, Quality of Life, Kinesiophobia and Pain Catastrophising in Individuals with Post-Stroke Chronic Shoulder Pain: A Randomised Controlled Trial Protocol

Introduction: Post-Stroke Shoulder Pain (PSSP) is a prevalent complication that affects 10-22% of stroke survivors. Research shows that chronic pain is influenced by biological, psychological and social factors and these factors can impact physical function, kinesiophobia, pain catastrophising, disability and quality of life. These elements may contribute to chronic pain in patients with PSSP. Understanding Post-Stroke Chronic Shoulder Pain (PSCSP) is crucial for developing effective interventions and improving the overall wellbeing of stroke survivors. Need of the study: This study seeks to address the gap in understanding PSCSP, particularly the overlooked psychosocial factors in physiotherapy. By integrating the biopsychosocial model with Pain Neuroscience Education (PNE) and conventional physiotherapy, it aims to improve pain management and the wellbeing of stroke survivors. Aim: To compare the effect of PNE versus Conventional Patient Education (CPE) on pain intensity, quality of life, kinesiophobia and pain catastrophising in individuals with PSCSP. Materials and Methods: This research protocol is planned to conduct a randomised controlled trial in Hubballi, Karnataka, India, with 80 participants (40 per group), calculated at 90% power and 5% significance using G-power software. The duration of the study will be approximately four years, from June 2023 to August 2027. Participants aged ≥18 years with PSCSP (≥3 months), first-ever unilateral ischaemic or haemorrhagic stroke and chronic stroke lasting more than six months, meeting cognitive criteria (Mini-Mental State Examination (MMSE) >24), Visual Analogue Scale (VAS) (>1 mm) and Brunnstrom stages (III–V), will be included. Participants will be excluded if they have pre-stroke shoulder/neck pain, have undergone surgery, experienced acute strokes, have severe deficits, uncontrolled conditions, or contraindications to Transcutaneous Electrical Nerve Stimulation (TENS) (e.g., epilepsy, pacemaker). Group A will receive PNE, while Group B will undergo CPE. Both groups will receive graded motor imagery, TENS and task-specific exercises for six weeks, with a two-week follow-up. Outcomes (VAS, quality of life, Tampa Scale for Kinesiophobia, pain catastrophising and disability) will be assessed at baseline, six weeks and eight weeks.