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Completed

NCT Number: NCT01974791

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

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.

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Key information

Conditions

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

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital Waltham

Waltham, Massachusetts, 02453, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Decrease in Fear of Pain

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

Secondary outcomes

  1. Decrease in Functional Disability

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

  2. Improvement in School Functioning

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

  3. Decrease in Pain Catastrophizing

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

  4. Decrease in Pain Intensity

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

  5. Increase in Physical Activity

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

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Acronym: GET Living

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Nov 4, 2013
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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