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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Children's Hospital Boston
Sponsor:
Information provided by (Responsible Party):
Laura Simons(Giardi), Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01974791
First received: October 22, 2013
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Chronic Pain
Neuralgia
Musculoskeletal Pain
Headache
Behavioral: GET Living
Other: Multidisciplinary Standard Care

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Decrease in Fear of Pain [ Time Frame: Decrease in Fear of Pain from Baseline to end of treatment at 6-weeks, on average ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decrease in Functional Disability [ Time Frame: Decrease in Functional Disability from Baseline to end of treatment at 6-weeks, on average ] [ Designated as safety issue: No ]
  • Improvement in School Functioning [ Time Frame: Improvement in School Functioning from baseline to end of treatment at 6-weeks, on average ] [ Designated as safety issue: No ]
  • Decrease in Pain Catastrophizing [ Time Frame: Decrease in Pain Catastrophizing from baseline to end of treatment at 6-weeks, on average ] [ Designated as safety issue: No ]
  • Decrease in Pain Intensity [ Time Frame: Decrease in Pain Intensity from baseline to end of treatment at 6-weeks, on average ] [ Designated as safety issue: No ]
  • Increase in Physical Activity [ Time Frame: Increase in Physical Activity from baseline to end of treatment at 6-weeks, on average ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: October 2013
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Active Comparator: Multidisciplinary Standard Care Other: Multidisciplinary Standard Care
Patients who are evaluated at the Pain Treatment Service are given recommendations that include medical, physical therapy, and psychological treatments.

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01974791

Contacts
Contact: Molly Basch 617-919-4676 molly.basch@childrens.harvard.edu
Contact: Laura Simons 617-919-4677 laura.simons@childrens.harvard.edu

Locations
United States, Massachusetts
Boston Children's Hospital Waltham Recruiting
Waltham, Massachusetts, United States, 02453
Principal Investigator: Laura Simons, PhD         
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Laura E Simons, PhD Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Laura Simons(Giardi), Staff Psychologist, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01974791     History of Changes
Other Study ID Numbers: IRB-P00007276, 82267
Study First Received: October 22, 2013
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chronic Pain
Headache
Musculoskeletal Pain
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on September 14, 2014