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| Name | Class |
|---|---|
| Region Örebro County | OTHER |
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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.
See description of arms and intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No treatment waiting period | No Intervention | Participants are randomized to a 7, 14 or 21 day waiting period. Daily measurements are collected throughout this period. | |
| Reactivate | Experimental | Reactivate treatment. Daily measurements are collected throughout treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reactivate | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Activity engagement change | Change in self-rated activity engagement. Numerical Rating Scale, range 0-6 (1 question: lower values, worse outcome, 1 question: Lower values, better outcome ) | 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 |
| Symptom distress change | Change in self-rated distress about symptoms. Numerical Rating Scale, range 0-6 (3 questions, higher values, worse outcome) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Disability Inventory (FDI) change | Change in functional disability. Descriptive Rating Scale, range 0-64 (higher values, worse outcome) | baseline, after treatment phase B (12 weeks), 6 months after terminated intervention |
| Center of Epidemiological Studies Depression Scales for Children (CES-DC) change |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Inventory of Costs in Patients with psychiatric disorders (Tic-P), medical resources | Change in use of medical resources. Dichotomous scale completed by open ended answers if answer is yes. | baseline, 12 weeks, 6 months after terminated intervention |
| Treatment Inventory of Costs in Patients with psychiatric disorders (Tic-P), school absence |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katja Boersma, PhD | Örebro University, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Region Örebro county | Örebro | 70217 | Sweden |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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Data is collected using a secure digital platform. Outcome assessors will be blinded to baseline length allocations.
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Change in depressive symptoms. Descriptive Rating Scale, range 0-60 (higher values, worse outcome) |
| baseline, after treatment phase B (12 weeks), 6 months after terminated intervention |
| The Pediatric Quality of Life Acute version (PedsQL) PedsQLâ„¢ | Change in quality of life. Descriptive Rating Scale, range 0-92 (higher values, worse outcome) | baseline, after treatment phase B (12 weeks), 6 months after terminated intervention |
| Change in psychological distress | Change in self-related symptoms of psychological distress. Numerical Rating Scale, range 0-6 (3 questions, higher values, worse outcome) | 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. |
| Pain change | Change in self-related pain symptoms. Numerical Rating Scale range 0-6 (higher values, worse outcome) | 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. |
| Fear of Pain Questionnaire Children Short-form (FOPQ-C SF) change | Change in fear of pain. Descriptiv Rating Scale, range 0-40 (higher values worse outcome) | baseline, after treatment phase B (12 weeks), 6 months after terminated intervention |
| The Photograph Series of Daily Activities for youth (PHODA) change - short | Change in percieved harmfulness. Photographs with 50 activities, rated on a Subjective Self-rating Scale, range 0-100mm/item (higher values, worse outcome) | First session after baseline (randomly assigned to be 7, 14 or 21 days), after treatment phase B (12 weeks) |
Change in school abcense. Dichotomous scale completed by open ended answers if answer is yes. One question is completed by one question with Numerical Rating Scale 1-10 (higher values, worse outcome) if answer is yes. |
| baseline, 12 weeks, 6 months after terminated intervention |
| Accelerometer | Change in physical activity, digital device counting steps | 7 days of the first week of baseline (randomly assigned to be 7, 14 or 21 days). 7 days assessment 6 months after terminated assessment. |