Clinical trial NCT01974791: GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain
Official title: GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Neuralgia
Musculoskeletal Pain
Headache
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2013-11-03
Enrollment: 34
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Decrease in Fear of Pain
timeFrame: Decrease in Fear of Pain from Baseline to end of treatment at 6-weeks, on average
Secondary outcomes:
measure: Decrease in Functional Disability
timeFrame: Decrease in Functional Disability from Baseline to end of treatment at 6-weeks, on average
measure: Improvement in School Functioning
timeFrame: Improvement in School Functioning from baseline to end of treatment at 6-weeks, on average
measure: Decrease in Pain Catastrophizing
timeFrame: Decrease in Pain Catastrophizing from baseline to end of treatment at 6-weeks, on average
measure: Decrease in Pain Intensity
timeFrame: Decrease in Pain Intensity from baseline to end of treatment at 6-weeks, on average
measure: Increase in Physical Activity
timeFrame: Increase in Physical Activity from baseline to end of treatment at 6-weeks, on average
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Boston Children's Hospital Waltham
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Laura E Simons, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beebe JA, Kronman C, Mahmud F, Basch M, Hogan M, Li E, Ploski C, Simons LE. Gait Variability and Relationships With Fear, Avoidance, and Pain in Adolescents With Chronic Pain. Phys Ther. 2021 Apr 4;101(4):pzab012. doi: 10.1093/ptj/pzab012.