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

Not Applicable
Completed
Conditions
Musculoskeletal Pain
Chronic Pain, Widespread
Pediatric Pain
Interventions
Behavioral: Multidisciplinary Pain Management (MPM)
Behavioral: Graded Exposure Therapy (GET Living)
Registration Number
NCT03699007
Lead Sponsor
Laura E Simons
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
68
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Multidisciplinary Pain Management (MPM)Multidisciplinary Pain Management (MPM)MPM is a treatment intervention that is representative of current standards of care in a multidisciplinary pain clinic setting. It consists of Cognitive Behavioral Therapy (CBT) and Physical Therapy (PT) sessions, delivered separately by a pain psychologist and a physical therapist.
Graded Exposure Therapy (GET Living)Graded Exposure Therapy (GET Living)GET Living is jointly delivered by a pain psychologist and a physical therapist. The GET Living treatment was based on a published graded in-vivo exposure treatment manual for adults with adaptations to target a pediatric audience.
Primary Outcome Measures
NameTimeMethod
Pain-related Fear and AvoidanceBaseline 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 Outcome Measures
NameTimeMethod
Functional DisabilityBaseline 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)

Trial Locations

Locations (1)

Pediatric Pain Management Clinic - Stanford Children's Health

🇺🇸

Menlo Park, California, United States

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