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Chronic Musculoskeletal PainInControlNCT07774416

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

A study of Chronic Musculoskeletal Pain, run by Aveiro University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 to 85 years
Conditions the study is for
Chronic Musculoskeletal Pain
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
No sites listed yet
Study dates
Sep 2026to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

About this study

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

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.

Being tested
InControl intervention, Usual Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InControl interventionOther

    Also called Exercise, Pain science education, Functional objective, Digital intervention

    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.

  • Usual CareOther

    Also called Medications, Physiotherapy, Physical Therapy, Psychology

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

Study groups in NCT07774416
Study groupRoleWhat they receive
Usual careOtherNot described
Receives: Other: Usual Care
InControl interventionExperimentalNot described
Receives: Other: InControl intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rates

    inclusion, refusal, exclusion, dropout and retetion

    Measured: From enrollment to the end of treatment at 8 weeks

  2. System Usability Scale

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

    Measured: At the end of 8 weeks of intervention

  3. Estructured questionnaire to assess aceptability

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

    Measured: At the end of 8 weeks of intervention

  4. Semi-structured interview

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

    Measured: At the end of 8 weeks of intervention

Secondary outcomes (25)

  1. Sex

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

    Measured: Baseline

  2. Age

    number of years

    Measured: Baseline

  3. Marital status

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

    Measured: Baseline

  4. Level of education

    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)

    Measured: Baseline

  5. Employment status

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

    Measured: Baseline

  6. Weight

    weight in kilograms

    Measured: Baseline

  7. Height

    height, in metres

    Measured: Baseline

  8. Falls

    number of falls in the last year

    Measured: Baseline

  9. Number of medicines

    number of regular medicines

    Measured: Baseline

  10. Comorbidities

    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)

    Measured: Baseline

  11. EQ-5D-5L

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

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

  12. EQ-VAS

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

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

  13. Montreal Cognitive Assessment

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

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

  14. Brief Pain Inventory

    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

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

  15. Location and number of painful sites

    Bodychart

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

  16. PainDETECT Questionnaire

    The score ranges from -1 to 38 points

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

  17. Hand grip strength

    Kg

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

  18. Gait speed test

    metres per second

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

  19. 5-sit-to-stand test

    time in seconds

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

  20. Rapid Assessment of Physical Activity

    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

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

  21. Pain Catastrophizing Scale

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

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

  22. Tampa Scale of Kinesiophobia

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

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

  23. Geriatric Depression Scale

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

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

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

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

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

  25. Patient Global Impression of Change

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

    Measured: At the end of 8-week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07774416
Sponsor's protocol ID
Currently in submission
Acronym
InControl
Status last verified
Aug 2026
First submitted
28 Jul 2026
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Oliveira D, Rocha NP, Silva AG. Feasibility, acceptability and usability of InControl web-platform intervention for older adults with chronic musculoskeletal pain: A mixed-methods pilot study protocol. PLoS One. 2026 Oct 14;21(10):e0360321. doi: 10.1371/journal.pone.0360321. eCollection 2026.

    PubMed 42873771

Questions about this trial

What is this clinical trial studying?

A study of Chronic Musculoskeletal Pain, run by Aveiro University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rates (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07774416, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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