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Completed

NCT Number: NCT03699007

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

The broad aim of this 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 at the Stanford Pediatric Pain Management Clinic (PPMC). The investigators will evaluate the effectiveness and acceptability of this intervention for children with high levels of pain-related fear and functional disability. If proven efficacious, it will allow for the dissemination of this innovative treatment model to others working with children and adolescents with chronic pain.

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Key information

Conditions

Pediatric Pain Chronic Pain Chronic Pain, Widespread Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Pain Management Clinic - Stanford Children's Health

Menlo Park, California, 94025, United States

About this study

The treatment intervention to be tested in this clinical trial is Graded in-vivo Exposure Treatment (GET Living) compared to Multidisciplinary Pain Management (MPM) in adolescents with chronic musculoskeletal pain. Participants will be randomized into GET Living or MPM, and will be instructed to not seek new treatments for pain for the duration of the study. Both treatments consist of 12 1-hour patient sessions delivered twice a week across 6- weeks and 3 parent-only sessions.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 8 - 18 years old; Male or Female
  • Musculoskeletal pain (e.g. localized [back, limb], diffuse) not due to acute trauma (e.g. active sprain or fracture).
  • Moderate to high pain-related fear ( ≥ 35 on the FOPQ-C)
  • Moderate to high functional disability ( ≥ 13 on the FDI)
  • English Language Proficiency

Exclusion criteria

  • Significant cognitive impairment (e.g., brain injury)
  • Significant medical or psychiatric problem that would interfere (e.g., seizures, psychosis, suicidality)

Treatment and study plan

Graded Exposure Therapy (GET Living)

Behavioral

The protocol consists of 12 interdisciplinary sessions, 1-hour each, delivered twice a week, for an average of 6 weeks. Phase I-III are conducted with the psychologist, physical therapist, adolescent, and parent (as developmentally appropriate). Patient and parent will complete daily diaries and patients will wear the Actigraph throughout the duration of treatment.

Multidisciplinary Pain Management (MPM)

Behavioral

The protocol consists of 12 multidisciplinary sessions, 1-hour each, delivered twice a week, for an average of 6 weeks. Sessions will alternate between psychological CBT sessions and Physical Therapy sessions. Patient and parent will complete daily diaries and patients will wear the Actigraph throughout the duration of treatment. The parent will also participate in 3 additional parent-only sessions with the psychologist to address parental coping skills.

Primary outcomes

  1. Pain-related Fear and Avoidance

    Time frame: Baseline to end of treatment (discharge) at 6-weeks (on average), and 3-month and 6-month follow up.

    Fear of Pain Questionnaire (FOPQ-C): a 24-item validated patient-report measure of pain-related fear and avoidance. The FOPQ-C contains two subscales: Fear of Pain (11 items; Min=0, Max=44) and Avoidance of Activities (13 items; Min=0, Max=52). Higher scores on each subscale indicate greater pain related fear and avoidance of activities.

Secondary outcomes

  1. Functional Disability

    Time frame: Baseline to end of treatment (discharge) at 6-weeks (on average), and 3-month and 6-month follow up.

    Functional Disability Inventory (FDI): a 15-item validated patient-report measure of difficulties in physical, social and recreational activities (score Min=0, Max=60; Lower score means less disability/better outcome)

Sponsors and collaborators

Lead sponsor

Laura E Simons

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 9, 2018
Registry last updated
Aug 1, 2023

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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