Chronic Musculoskeletal Pain
Conditions
Brief 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.
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.
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.
Sponsors
Aveiro University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Semi-structured interview | At the end of 8 weeks of intervention | Semi-structured interview to explore participants' perceptions about programme acceptability |
| Rates | From enrollment to the end of treatment at 8 weeks | inclusion, refusal, exclusion, dropout and retetion |
| System Usability Scale | 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. |
| Estructured questionnaire to assess aceptability | At the end of 8 weeks of intervention | Estructured questionnaire Ten items, with scores ranging from 1 - totally disagree to 5 - totally agree |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait speed test | At baseline and at the end of 8-week intervention | metres per second |
| 5-sit-to-stand test | At baseline and at the end of 8-week intervention | time in seconds |
| Rapid Assessment of Physical Activity | 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 |
| Pain Catastrophizing Scale | 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 |
| Tampa Scale of Kinesiophobia | 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 |
| Geriatric Depression Scale | At baseline and at the end of 8-week intervention | Scores range from 0 to 15. Higher scores indicate more depressive symptoms |
| Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls | 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 |
| Patient Global Impression of Change | At the end of 8-week intervention | Scores range from 1 to 7. Higher scores indicate a greater overall perception of improvement |
| Falls | Baseline | number of falls in the last year |
| Number of medicines | Baseline | number of regular medicines |
| Comorbidities | 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) |
| EQ-5D-5L | At baseline and at the end of the 8-week intervention | The EQ-5D-5L score ranges from 1 to 5 for each domain |
| EQ-VAS | 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 |
| Montreal Cognitive Assessment | At baseline and at the end of the 8-week intervention | MoCA scores range from 0 to 30. Higher scores indicate better cognitive performance |
| Employment status | Baseline | Please select: Full-time employee, Part-time employee, Domestic worker, Unemployed, Retired, Temporarily unfit for work |
| Weight | Baseline | weight in kilograms |
| Height | Baseline | height, in metres |
| Level of education | 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) |
| Sex | Baseline | Please indicate the appropriate option: male, female, prefer not to say, other (please specify) |
| Age | Baseline | number of years |
| Brief Pain Inventory | 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 |
| Marital status | Baseline | Select your marital status: Single, Married, In a civil partnership, Divorced Widowed |
| Location and number of painful sites | At baseline and at the end of the 8-week intervention | Bodychart |
| PainDETECT Questionnaire | At baseline and at the end of 8-week intervention | The score ranges from -1 to 38 points |
| Hand grip strength | At baseline and at the end of 8-week intervention | Kg |
Contacts
PRINCIPAL_INVESTIGATORAnabela G. Silva, PhD
University of Aveiro
Outcome results
None listed