Efficacy of Pain Neuroscience Education Combined with Exercise in Older Adults with Chronic Pain: Study Protocol for...

Background/Objectives: Chronic pain in older adults is a highly disabling epidemic, often overtreated with passive pharmacological approaches. Although clinical guidelines recommend active strategies combining multicomponent exercise and Pain Neuroscience Education (PNE), robust geriatric evidence remains scarce. Therefore, the central objective of this randomized controlled trial (RCT) is to evaluate the efficacy of combined PNE and exercise versus exercise alone. Crucially, this RCT addresses a major literature gap by investigating the long-term dose-response effect of PNE (an 8-week intensive vs. a 32-week maintenance program) to determine the optimal strategy for sustaining behavioral change and pain relief. Methods: A prospective, single-blind RCT (1:1:1 allocation) will recruit 90 older adults (≥65 years) with primary chronic musculoskeletal pain. The 32-week intervention comprises three arms: a control group (multicomponent exercise), Intervention Group 1 (exercise + 8 weeks of PNE), and Intervention Group 2 (exercise + 32 weeks of PNE). The primary outcome is pain intensity (assessed via the Numeric Rating Scale [NRS]). Secondary outcomes include kinesiophobia, pain catastrophizing, chronic pain grade and related disability, quality of life, physical performance, body composition and analgesic consumption. Data collected at baseline, 8, and 32 weeks will be analyzed using mixed-effects models for repeated measures. Results: As this is a study protocol, there are no results to report yet. Upon completion of the trial, data will be analyzed using mixed-effects models for repeated measures to evaluate intra- and intergroup changes over time, and the findings will be disseminated in future publications. Conclusions: By evaluating the long-term dose-response effect, this study will determine the optimal PNE dosage required for sustained pain relief and behavioral change in older adults. If our hypotheses are confirmed, the findings will generate high-quality evidence to support the integration of combined active interventions into community settings, promoting active aging and reducing the burden of chronic pain. Trial Registration: ClinicalTrials.gov Identifier: NCT07287501.