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NCT Number: NCT07774416

Feasibility, Acceptability And Usability Of The InControl Web Platform - A Rando Mized Parallel-Group Pilot Study of Mixed-methods

This is a randomized, parallel-group pilot study that employs mixed methods (qualitative and quantitative approaches). The purpose of this study is to assess the feasibility, usability, and acceptability of an intervention with a digital component on the InControl web platform. The intervention is based on education in pain science and exercise, with the goal of managing chronic musculoskeletal pain in older adults. The intervention will be delivered through a combination of digital and in-person components and it will be compared to the usual intervention.

It will also inform the design of a randomized controlled trial to evaluate the cost-effectiveness of InControl.

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Key information

Conditions

Chronic Musculoskeletal Pain

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • be 60 years or older;
  • have chronic musculoskeletal pain, defined as pain that persists for more than three months and is felt in the muscles, bones, joints, or tendons at least once a week;
  • know how to use a computer and/or a tablet; iv) have a score of 3 or higher on the Numerical Pain Scale for average pain intensity over the past week;
  • show no cognitive impairment, as determined by the Montreal Cognitive Assessment (MoCA) (validated and with normative data for the Portuguese population) and be available to participate in the study. The MoCA cutoff scores for the absence of cognitive impairment to be considered are adjusted for the participants' age and educational level [primary school (1-4 years), middle school (5-9 years), high school (10-12 years), and college (>12 years)], with 1.5 standard deviations: i) Ages 60-69: elementary school - 17 points, middle school - 21 points, high school and college - 22 points; ii) Ages 70-79: elementary school - 15 points, middle school - 18 points, high school - 20 points, and college - 22 points; iii) Over 80 years old: elementary school - 12 points, middle school - 22 points, high school - 17 points, and college - 19 points.

Exclusion criteria

  • inability to read;
  • pain associated with serious conditions (e.g., tumors, fractures);
  • any acute, unstable, or decompensated medical conditions that prevent safe physical exercise. Examples include cardiovascular diseases (recent acute myocardial infarction, unstable angina, uncontrolled cardiac arrhythmias, severe symptomatic aortic stenosis, symptomatic or unstable heart failure, acute myocarditis or pericarditis, acute aortic dissection, active endocarditis, uncontrolled hypertension), respiratory conditions (acute pulmonary embolism, pulmonary infarction, chronic obstructive pulmonary disease, uncontrolled asthma, or recent respiratory exacerbations), metabolic conditions (uncontrolled diabetes mellitus), neurological conditions (stroke, traumatic brain injury, Parkinson's disease), or acute systemic infection.
  • In addition, participants will be screened according to the American College of Sports Medicine's Preparticipation Health Screening algorithm

Treatment and study plan

InControl intervention

Other

The InControl intervention lasts 8 weeks and combines educational content on pain science and exercise on a digital platform. InControl is the result of a co-creation process between healthcare professionals and older adults with lived experience of chronic musculoskeletal pain.

Other names: Exercise, Pain science education, Functional objective, Digital intervention, In-person

Usual Care

Other

Usual care is defined as the treatment that the participant would normally receive such as medication, physical therapy, or any other form of treatment.

Other names: Medications, Physiotherapy, Physical Therapy, Psychology, other intervention

Primary outcomes

  1. Rates

    Time frame: From enrollment to the end of treatment at 8 weeks

    inclusion, refusal, exclusion, dropout and retetion

  2. System Usability Scale

    Time frame: At the end of 8 weeks of intervention

    Usability evatuated wiht the portuguese version of SUS The score ranges from 0 to 100. Higher scores are interpreted as indicating better usability.

  3. Estructured questionnaire to assess aceptability

    Time frame: At the end of 8 weeks of intervention

    Estructured questionnaire Ten items, with scores ranging from 1 - totally disagree to 5 - totally agree

  4. Semi-structured interview

    Time frame: At the end of 8 weeks of intervention

    Semi-structured interview to explore participants' perceptions about programme acceptability

Secondary outcomes

  1. Sex

    Time frame: Baseline

    Please indicate the appropriate option: male, female, prefer not to say, other (please specify)

  2. Age

    Time frame: Baseline

    number of years

  3. Marital status

    Time frame: Baseline

    Select your marital status: Single, Married, In a civil partnership, Divorced Widowed

  4. Level of education

    Time frame: Baseline

    Please select your level of education: Can read and write; 4th year of schooling; 6th year of schooling; 9th year of schooling; 12th year of schooling; Bachelor's degree; Other (please specify)

  5. Employment status

    Time frame: Baseline

    Please select: Full-time employee, Part-time employee, Domestic worker, Unemployed, Retired, Temporarily unfit for work

  6. Weight

    Time frame: Baseline

    weight in kilograms

  7. Height

    Time frame: Baseline

    height, in metres

  8. Falls

    Time frame: Baseline

    number of falls in the last year

  9. Number of medicines

    Time frame: Baseline

    number of regular medicines

  10. Comorbidities

    Time frame: Baseline

    Please select: No medical conditions, High blood pressure, Diabetes, Osteoarthritis (please specify the affected area), Cardiovascular conditions, Respiratory conditions, Neurological conditions, Cancer, Arthritis, Osteoporosis, Vision problems, Hearing problems, Other (please specify)

  11. EQ-5D-5L

    Time frame: At baseline and at the end of the 8-week intervention

    The EQ-5D-5L score ranges from 1 to 5 for each domain

  12. EQ-VAS

    Time frame: At baseline and at the end of the 8-week intervention

    The score of EQ-VAS ranges from 0 to 100. Higher scores are interpreted as indicating a better perception of health quality

  13. Montreal Cognitive Assessment

    Time frame: At baseline and at the end of the 8-week intervention

    MoCA scores range from 0 to 30. Higher scores indicate better cognitive performance

  14. Brief Pain Inventory

    Time frame: At baseline and at the end of the 8-week intervention

    On the pain severity subscale, scores range from 0 to 40 points. On the pain-related interference subscale, scores range from 0 to 70 points. Higher scores indicate greater severity or pain-related interference, respectively

  15. Location and number of painful sites

    Time frame: At baseline and at the end of the 8-week intervention

    Bodychart

  16. PainDETECT Questionnaire

    Time frame: At baseline and at the end of 8-week intervention

    The score ranges from -1 to 38 points

  17. Hand grip strength

    Time frame: At baseline and at the end of 8-week intervention

    Kg

  18. Gait speed test

    Time frame: At baseline and at the end of 8-week intervention

    metres per second

  19. 5-sit-to-stand test

    Time frame: At baseline and at the end of 8-week intervention

    time in seconds

  20. Rapid Assessment of Physical Activity

    Time frame: At baseline and at the end of 8-week intervention

    Depending on physical activity, there are five levels of physical activity: sedentary - item 1, ii) slightly active - item 2, iii) regularly slightly active (light activity) - item 3, iv) regularly slightly active - items 4 and 5, and v) active - items 6 and 7

  21. Pain Catastrophizing Scale

    Time frame: At baseline and at the end of 8-week intervention

    The minimum score is 0 and the maximum is 52. Higher scores are associated with higher levels of catastrophic thinking

  22. Tampa Scale of Kinesiophobia

    Time frame: At baseline and at the end of 8-week intervention

    Scores range from 13 to 52 points. Higher scores are associated with greater fear of movement

  23. Geriatric Depression Scale

    Time frame: At baseline and at the end of 8-week intervention

    Scores range from 0 to 15. Higher scores indicate more depressive symptoms

  24. Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls

    Time frame: At baseline and at the end of 8-week intervention

    SARC-F. Scores range from 0 to 10. Total scores of 4 or above are suggestive of sarcopenia

  25. Patient Global Impression of Change

    Time frame: At the end of 8-week intervention

    Scores range from 1 to 7. Higher scores indicate a greater overall perception of improvement

Sponsors and collaborators

Lead sponsor

Aveiro University

Other

Registry information

Official study title

Feasibility, Acceptability And Usability Of The InControl Web Platform - A Mixed-methods Pilot Study

Acronym: InControl

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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