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

Primary Purpose

Chronic Pain, Neuralgia, Musculoskeletal Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

GET Living

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Boston Children's Hospital Waltham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GET Living Treatment

Arm Description

Outcomes

Primary Outcome Measures

Decrease in Fear of Pain

Secondary Outcome Measures

Decrease in Functional Disability

Improvement in School Functioning

Decrease in Pain Catastrophizing

Decrease in Pain Intensity

Increase in Physical Activity

Full Information

NCT ID

NCT01974791

First Posted

October 22, 2013

Last Updated

March 27, 2018

Sponsor

Boston Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01974791

Brief Title

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

Acronym

GET Living

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

January 2018 (Actual)

Study Completion Date

January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Boston Children's Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain, Neuralgia, Musculoskeletal Pain, Headache

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GET Living Treatment

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

GET Living

Intervention Description

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.

Primary Outcome Measure Information:

Title

Decrease in Fear of Pain

Time Frame

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

Secondary Outcome Measure Information:

Title

Decrease in Functional Disability

Time Frame

Decrease in Functional Disability from Baseline to end of treatment at 6-weeks, on average

Title

Improvement in School Functioning

Time Frame

Improvement in School Functioning from baseline to end of treatment at 6-weeks, on average

Title

Decrease in Pain Catastrophizing

Time Frame

Decrease in Pain Catastrophizing from baseline to end of treatment at 6-weeks, on average

Title

Decrease in Pain Intensity

Time Frame

Decrease in Pain Intensity from baseline to end of treatment at 6-weeks, on average

Title

Increase in Physical Activity

Time Frame

Increase in Physical Activity from baseline to end of treatment at 6-weeks, on average

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura E Simons, PhD

Organizational Affiliation

Boston Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boston Children's Hospital Waltham

City

Waltham

State/Province

Massachusetts

ZIP/Postal Code

02453

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33482005

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.

Results Reference

derived

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

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