Chronic Pain, Emotional Distress
Conditions
Brief summary
Recurrent or persistent musculoskeletal pain is an alarmingly common problem among adolescents, in Sweden as well as globally. Pain often co-occur with and psychological distress and have both been shown to be predictors of sustained problems in adulthood. Adequate treatment early on in the development of problems has been shown important in order to decrease the risk of sustained problems in adulthood but available treatments have only modest effects. There is thus a need for treatment development, not in the least for (secondary) preventative purposes. The aim of this project is therefore to develop an evidence based and cost-effective secondary preventative intervention. Specifically, this project aims to develop and test a physiotherapist led treatment for adolescents with recurrent or persistent musculoskeletal pain and based upon graded exposure to physical activity and reactivation.
Detailed description
See description of arms and intervention.
Interventions
BEHAVIORALReactivate
The study period is 84 days (12 weeks). Depending on the length of the baseline period (randomly assigned to be 7, 14 or 21 days), the treatment period varies between 63-77 days and contains 6-11 sessions. The intervention consists of 2-4 educational sessions in pain mechanisms and fear avoidance and 4-9 sessions of individually tailored intervention with graded exposure and reactivation to avoided physical activities. Intervention will take place from one time per week to one time every two weeks, 30-60 minutes per session. Number of treatment sessions will depend on when the individual participants' goals are considered reached. If necessary, given the participants consent, their legal guardians will be invited to attend the sessions.
Sponsors
Örebro University, Sweden
Region Örebro County
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Data is collected using a secure digital platform. Outcome assessors will be blinded to baseline length allocations.
Intervention model description
This study employs a sequential single-case experimental AB design with randomized waiting period lengths (7, 14 or 21 days). Included in the design is also standardized pre-post and 6-month follow up measurement allowing for single group analysis of change. In addition, we collect qualitative data from participating adolescents.
Eligibility
Sex/Gender
ALL
Age
12 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* Age 12-25 * Persistent (consistently or weekly recurrent) musculoskeletal pain problems for ≥3 months, with pain intensity ≥2 on a numeric rating scale 0-6 (0=not at all, 6=to a great extent) * Presence of avoidance behaviour and/or or worry about symptoms/problems, ≥1 on a numeric rating scale 0-6 (0=not at all, 6=to a great extent); \> 50 on at least one activity of the PHODA. * Swedish speaking and able to fill out questionnaires
Exclusion criteria
* Serious/malignant disease * Participation in other rehabilitation program * Severe mental health problems * Substance abuse * Severe learning disabilities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Activity engagement change | repeated daily through phase A (randomly assigned to be 7, 14 or 21 days) and treatment phase B (9-11 weeks). Total time frame of assessment is 12 weeks (84 days). 7 days assessment 6 months after terminated intervention | Change in self-rated activity engagement. Numerical Rating Scale, range 0-6 (1 question: lower values, worse outcome, 1 question: Lower values, better outcome ) |
| Symptom distress change | repeated daily through phase A (randomly assigned to be 7, 14 or 21 days) and treatment phase B (9-11 weeks). Total time frame of assessment is 12 weeks (84 days). 7 days assessment 6 months after terminated intervention. | Change in self-rated distress about symptoms. Numerical Rating Scale, range 0-6 (3 questions, higher values, worse outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Disability Inventory (FDI) change | baseline, after treatment phase B (12 weeks), 6 months after terminated intervention | Change in functional disability. Descriptive Rating Scale, range 0-64 (higher values, worse outcome) |
| Center of Epidemiological Studies Depression Scales for Children (CES-DC) change | baseline, after treatment phase B (12 weeks), 6 months after terminated intervention | Change in depressive symptoms. Descriptive Rating Scale, range 0-60 (higher values, worse outcome) |
| The Pediatric Quality of Life Acute version (PedsQL) PedsQL™ | baseline, after treatment phase B (12 weeks), 6 months after terminated intervention | Change in quality of life. Descriptive Rating Scale, range 0-92 (higher values, worse outcome) |
| Change in psychological distress | repeated daily through phase A (randomly assigned to be 7, 14 or 21 days) and treatment phase B (9-11 weeks). Total time frame of assessment is 12 weeks (84days). 7 days assessment 6 months after terminated assessment. | Change in self-related symptoms of psychological distress. Numerical Rating Scale, range 0-6 (3 questions, higher values, worse outcome) |
| Pain change | repeated daily through phase A (randomly assigned to be 7, 14 or 21 days) and treatment phase B (9-11 weeks). Total time frame of assessment is 12 weeks (84days). 7 days assessment 6 months after terminated assessment. | Change in self-related pain symptoms. Numerical Rating Scale range 0-6 (higher values, worse outcome) |
| Fear of Pain Questionnaire Children Short-form (FOPQ-C SF) change | baseline, after treatment phase B (12 weeks), 6 months after terminated intervention | Change in fear of pain. Descriptiv Rating Scale, range 0-40 (higher values worse outcome) |
| The Photograph Series of Daily Activities for youth (PHODA) change - short | First session after baseline (randomly assigned to be 7, 14 or 21 days), after treatment phase B (12 weeks) | Change in percieved harmfulness. Photographs with 50 activities, rated on a Subjective Self-rating Scale, range 0-100mm/item (higher values, worse outcome) |
Countries
Sweden
Contacts
PRINCIPAL_INVESTIGATORKatja Boersma, PhD
Örebro University, Sweden
Outcome results
None listed