The investigators designed a randomized, two-arm, parallel-group pilot to test the feasibility, acceptability and usability of InControl for older adults with chronic musculoskeletal pain. The study uses mixed methods—quantitative indicators alongside qualitative interviews—to evaluate both the technological solution and the trial procedures themselves. Thirty-four participants will be allocated across two groups (17 per arm), with the aim of informing a future full-scale randomized controlled trial and refinement of trial methods.
The protocol follows the Standard Protocol Items Recommendations for International Trials and has research ethics approval. The trial is registered on clinicaltrials.gov (NCT07774416). The team stated explicitly that no datasets have yet been generated; the manuscript describes planned procedures and outcome measures rather than trial results.
Recruitment will be conducted through the Local Health Unit of Aveiro Region and community outreach, including posters, digital and print media, and contact with primary care professionals. Participants must be 60 years or older, have musculoskeletal pain persisting more than three months and occurring at least weekly, be able to use a computer or tablet, report an average pain intensity ≥3 on the Numerical Pain Scale, and show no cognitive impairment on the Montreal Cognitive Assessment using age- and education-adjusted cutoffs. The protocol provides the MoCA cutoffs by age and educational level; investigators reported these thresholds rather than deriving new ones.
Exclusions are detailed and include inability to read, pain from serious conditions such as tumors or fractures, and acute, unstable, or decompensated medical problems that preclude safe exercise. Screening will use the American College of Sports Medicine preparticipation algorithm. The trial team plans cluster randomization at the level of the physical therapist to reduce contamination between treatment arms; an independent researcher will generate the random sequence and conceal allocation until after baseline assessment. Outcome assessors will remain blinded to allocation unless unblinding is required for safety review.
The intervention runs eight weeks and combines four in-person group sessions (Weeks 1, 3, 5 and 7) with approximately 20 remote sessions delivered through the InControl web platform. After a Week 0 baseline assessment, participants receive an assisted introduction to the platform and technical support from the research team. Remote sessions occur two or three times weekly on non-consecutive days, with each session comprising a warm-up, main exercise component, and cool-down, lasting 30–40 minutes in total.
Remote content is organized around three components: a functional goal-related task (self-management of an activity limited by pain), pain science education, and individualized physical exercise. Pain education is intended to reconceptualize chronic pain as a biopsychosocial phenomenon and to reduce fear and increase adherence to activity. Educational materials include standardized videos, audio, and text co-developed with clinicians and older adults; participants will view two videos per week for the first four weeks with optional review thereafter, and quizzes follow each video to reinforce knowledge.
Physical exercise programs are tailored and may be progressed or regressed during in-person sessions or upon participant request. Exercise intensity is prescribed at light to moderate levels using the Modified Borg Scale. Exercise modalities include mobility, balance, strengthening and stretching; each program repeats for two-week blocks and can be adjusted for safety or tolerance. Functional goals are pursued outside the platform using pacing or graded exposure techniques, for example incrementally increasing standing time while preparing a meal.
Primary feasibility indicators are explicit: inclusion, refusal, exclusion, dropout and retention rates. The validated Portuguese version of the System Usability Scale will assess usability at the end of the 8-week intervention. Acceptability and perceived appropriateness will be measured via a structured questionnaire (10 statements on a 5-point Likert scale) and explored qualitatively through semi-structured interviews conducted individually according to a predefined guide.
Secondary outcomes named in the protocol include measures of pain, physical function, psychological factors, quality of life and cognitive function. The study plans descriptive statistical analysis for quantitative data and thematic analysis for interview content. The protocol states that adverse events will be recorded systematically and that insurance coverage is provided for intervention-related accidents.
Adverse events—minor exercise-related symptoms or events such as falls—will be recorded and managed by the delivering physical therapists. The in-person group sessions serve multiple roles: technical support, adjustment of exercise prescription, assessment of functional goals, and monitoring for adverse events. Sessions are scheduled to last about 60 minutes and will take place either at the University of Aveiro School of Health Sciences or at facilities within the local health unit, depending on the therapist assigned.
Because the intervention requires active exercise, the protocol specifies screening exclusions related to cardiovascular, respiratory, metabolic and neurological instability and references the ACSM preparticipation health screening. The research team anticipates six clusters, with each physical therapist overseeing six to seven participants.
This document is a pilot protocol; as such, it does not report outcome data. The authors noted that the sample size was not determined by statistical power calculations, and the planned 34 participants account for an expected attrition estimate. The protocol did not provide details about specific secondary outcome instruments beyond domains, nor did it report any results on usability, adherence rates or effectiveness because the trial remains to be completed. Key open questions that will require trial data include actual recruitment and retention performance in this population, real-world adherence to the platform’s remote sessions, the magnitude of usability scores on the System Usability Scale, and any signal for clinical benefit across the listed secondary outcomes. These unresolved items are the stated rationale for conducting the pilot before a larger randomized trial.