GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain

Not Applicable

Completed

• Conditions: Musculoskeletal Pain; Headache; Chronic Pain; Neuralgia
• Interventions: Behavioral: GET Living

• Registration Number: NCT01974791
• Lead Sponsor: Boston Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-10-28
• Study First Posted: 2013-11-03
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-27
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GET Living Treatment	GET Living	-

Primary Outcome Measures

Name	Time	Method
Decrease in Fear of Pain	Decrease in Fear of Pain from Baseline to end of treatment at 6-weeks, on average

Secondary Outcome Measures

Name	Time	Method
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
Decrease in Functional Disability	Decrease in Functional Disability 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

Trial Locations

Locations (1)

Boston Children's Hospital Waltham; 🇺🇸 Waltham, Massachusetts, United States