Pain neuroscience education, blended exercises and booster sessions as an effective therapy for pain, functional and psychological factors in patients with knee osteoarthritis: a study protocol for a single-blind randomised controlled trial with 22 factorial design during 6-month follow-up
Abstract
Introduction: This study aims to investigate whether a pain neuroscience education (PNE) combined with a blended exercises programme including aerobic, resistance, neuromuscular, breathing, stretching and balance exercises and diet education provides greater pain relief and improvement in functional and psychological factors than PNE and blended exercises alone and whether 'exercise booster sessions (EBS)' approach may improve outcomes and increase adherence in patients with knee osteoarthritis (KOA) (by telerehabilitation (TR)).
Methods and analysis: In this single-blind randomised controlled trial, 129 patients (both genders; age >40) diagnosed with KOA will be randomly assigned to one of the 22 treatment combinations as: (1) blended exercises alone (36 sessions over 12 weeks), (2) PNE alone (three sessions over 2 weeks), (3) combination of PNE with blended exercises (exercise three times a week for 12 weeks combined with three sessions of PNE) and (4) a control group. Outcome assessors will be blinded towards group allocation. The primary outcome variables are the visual analogue scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis index in knee osteoarthritis (WOMAC) score. Secondary outcomes include Pain Self-Efficacy Questionnaire (PSEQ), Depression, Anxiety and Stress Scale (DASS), Tampa Scale for Kinesiophobia (TSK), Short Falls Efficacy Scale International (FES-I), Pain Catastrophising Scale (PCS), Short Form Health Survey (SF-12) and Exercise…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 129 participants or records.
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