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

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.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Pain; Chronic Pain; Neuralgia; Headache
• Intervention / Treatment: Behavioral: GET Living

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Waltham, Massachusetts, United States, 02453
      • Boston Children's Hospital Waltham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GET Living Treatment	Behavioral: GET 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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Laura E Simons, PhD, Boston Children's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: October 22, 2013
• First Submitted That Met QC Criteria: October 28, 2013
• First Posted (Estimate): November 3, 2013

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 27, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Chronic Pain; Neuralgia; Headache; Musculoskeletal Pain
• Other Study ID Numbers: IRB-P00007276; 82267 (Other Grant/Funding Number: American Pain Society)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No