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

NCT01974791 | Completed DMC

• 2 other identifiers: IRB-P0000727682267
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Neuralgia; Musculoskeletal Pain; Headache

Outcome Measures

Primary Outcomes (1)

• Decrease in Fear of Pain

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

Secondary Outcomes (5)

• 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

Study Arms (1)

GET Living Treatment

EXPERIMENTAL

Behavioral: GET Living

Interventions

GET Living BEHAVIORAL

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.

GET Living Treatment

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)).

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital Waltham

Waltham, Massachusetts, 02453, United States

Location

Related Publications (2)

• Schemer L, Hess CW, Van Orden AR, Birnie KA, Harrison LE, Glombiewski JA, Simons LE. Enhancing Exposure Treatment for Youths With Chronic Pain: Co-design and Qualitative Approach. J Particip Med. 2023 Mar 9;15:e41292. doi: 10.2196/41292.

  PMID: 36892929 DERIVED

• 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.

  PMID: 33482005 DERIVED

MeSH Terms

Conditions

Chronic Pain; Neuralgia; Musculoskeletal Pain; Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Laura E Simons, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Psychologist

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: November 4, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

US (1)