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

Chronic Pain Clinical Trial

— GET Living  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974791
• Other study ID #: IRB-P00007276
• Secondary ID: 82267
• Status: Completed
• Phase: N/A
• First received: October 22, 2013
• Last updated: March 27, 2018
• Start date: October 2013
• Est. completion date: January 2018

Study information

• Verified date: March 2018
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Headache
• Musculoskeletal Pain
• Neuralgia

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital Waltham	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in Fear of Pain		Decrease in Fear of Pain from Baseline to end of treatment at 6-weeks, on average
Secondary	Decrease in Functional Disability		Decrease in Functional Disability from Baseline to end of treatment at 6-weeks, on average
Secondary	Improvement in School Functioning		Improvement in School Functioning from baseline to end of treatment at 6-weeks, on average
Secondary	Decrease in Pain Catastrophizing		Decrease in Pain Catastrophizing from baseline to end of treatment at 6-weeks, on average
Secondary	Decrease in Pain Intensity		Decrease in Pain Intensity from baseline to end of treatment at 6-weeks, on average
Secondary	Increase in Physical Activity		Increase in Physical Activity from baseline to end of treatment at 6-weeks, on average