ClinicalTrials.gg
Not yet recruitingNCT07774416InControlUpdated Aug 19, 2026

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

An interventional study of InControl intervention and Usual Care in Chronic Musculoskeletal Pain, sponsored by Aveiro University. Not yet recruiting. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Aveiro University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
60 Years to 85 Years
Sex
All
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Study 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. 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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Conditions studied

  • Chronic Musculoskeletal Pain

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03

In context

Musculoskeletal Pain

515 studies on the registry are indexed under Musculoskeletal Pain; 127 are open to participants now.

This study's planned enrollment of 34 is below the median of 70 across 370 interventional studies indexed under Musculoskeletal Pain.

Browse Musculoskeletal Pain studies →

Lead sponsor

Aveiro University is the lead sponsor of 59 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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

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, , 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
34 participants (estimated)

Study arms

  • Other
    Usual care

    Other: Usual Care

  • Experimental
    InControl intervention

    Other: InControl intervention

Interventions

  • OtherInControl 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.

    Also known as: Exercise, Pain science education, Functional objective, Digital intervention, In-person

  • OtherUsual Care

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

    Also known as: Medications, Physiotherapy, Physical Therapy, Psychology, other intervention

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What researchers measure

Primary outcomes

  1. Rates

    inclusion, refusal, exclusion, dropout and retetion

    Time frame: 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.

    Time frame: 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

    Time frame: At the end of 8 weeks of intervention

  4. Semi-structured interview

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

    Time frame: At the end of 8 weeks of intervention

Secondary outcomes

  1. Sex

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

    Time frame: Baseline

  2. Age

    number of years

    Time frame: Baseline

  3. Marital status

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

    Time frame: 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)

    Time frame: Baseline

  5. Employment status

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

    Time frame: Baseline

  6. Weight

    weight in kilograms

    Time frame: Baseline

  7. Height

    height, in metres

    Time frame: Baseline

  8. Falls

    number of falls in the last year

    Time frame: Baseline

  9. Number of medicines

    number of regular medicines

    Time frame: 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)

    Time frame: Baseline

  11. EQ-5D-5L

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

  15. Location and number of painful sites

    Bodychart

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

  16. PainDETECT Questionnaire

    The score ranges from -1 to 38 points

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

  17. Hand grip strength

    Kg

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

  18. Gait speed test

    metres per second

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

  19. 5-sit-to-stand test

    time in seconds

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: At the end of 8-week intervention

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Dec 2026, 3 months later.

Of 224 non-industry interventional studies with no phase under Musculoskeletal Pain, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 34. This study's planned 3 months is below that.

Counting every sponsor, half of 237 studies reached it within 13 months; a quarter within 5 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 28, 2026
First posted
Aug 19, 2026
StartEst.
Sep 2026
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Aug 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07774416
Lead sponsor
Aveiro University
Responsible party
Anabela G Silva (Principal Coordinating Professor/Principal Researcher, Aveiro University) — Principal investigator
First posted
Aug 19, 2026
Start date
Sep 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Aug 19, 2026

Study contacts

Anabela G. Silva, PhD
principal investigator · University of Aveiro

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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