Chronic Pain, Headache, Musculoskeletal Pain, Neuralgia
Conditions
Brief summary
The broad aim of the study is to implement and evaluate the efficacy of Graded Exposure Treatment (GET Living) to target elevated pain-related fears in children with chronic pain. Pain-related fear is an important psychological factor associated with poor outcomes in children suffering with chronic pain. To examine the efficacy of GET Living in addressing pain-related fears the investigators propose to use a sequential replicated randomized single-case experimental phase design with multiple measures. The specific aims are to 1) evaluate the effectiveness and acceptability of individually tailored GET Living for children with high pain-related fear and functional disability and 2) define anatomical and resting state connectivity patterns in the brains of children and adolescents with complex chronic pain prior to and after participation in GET Living.
Interventions
BEHAVIORALGET Living
GET Living is an exposure based treatment jointly delivered by a cognitive-behavioral therapist and physical therapy to help children and adolescents suffering with chronic pain and headache progressively return to valued life activities.
Sponsors
Boston Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Pain-related fear (score \>40 on the Fear of Pain Questionnaire (FOPQ (Simons et al., 2011a)) * Musculoskeletal, neuropathic limb or back pain, or headache * Functional limitations (score \> 12 on the Functional Disability Inventory (FDI (Kashikar-Zuck et al., 2001; Walker and Greene, 1991)).
Exclusion criteria
* Significant cognitive impairment (e.g., intellectual disability) * Serious psychopathology (e.g., active suicidality). * Acute trauma (e.g., spondylolithesis, disk herniation, fracture, acute tendonitis) * Systemic disease in active inflammatory state * Biomechanical deficit that would limit ability to engage in exposure activities (e.g. severe muscle atrophy) * Making gains in current physical therapy or have not had physical therapy, but it is clearly indicated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in Fear of Pain | Decrease in Fear of Pain from Baseline to end of treatment at 6-weeks, on average |
Secondary
| Measure | Time frame |
|---|---|
| Decrease in Functional Disability | Decrease in Functional Disability from Baseline to end of treatment at 6-weeks, on average |
| Improvement in School Functioning | Improvement in School Functioning from baseline to end of treatment at 6-weeks, on average |
| Decrease in Pain Catastrophizing | Decrease in Pain Catastrophizing from baseline to end of treatment at 6-weeks, on average |
| Decrease in Pain Intensity | Decrease in Pain Intensity from baseline to end of treatment at 6-weeks, on average |
| Increase in Physical Activity | Increase in Physical Activity from baseline to end of treatment at 6-weeks, on average |
Countries
United States
Outcome results
None listed