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.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Pain; Chronic Pain, Widespread; Pediatric Pain
• Intervention / Treatment: Behavioral: Graded Exposure Therapy (GET Living); Behavioral: Multidisciplinary Pain Management (MPM)

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Menlo Park, California, United States, 94025
      • Pediatric Pain Management Clinic - Stanford Children's Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Graded Exposure Therapy (GET Living); 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.
Active Comparator: 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.	Behavioral: Multidisciplinary Pain Management (MPM); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain-related Fear and Avoidance	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.	Baseline to end of treatment (discharge) at 6-weeks (on average), and 3-month and 6-month follow up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Disability	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)	Baseline to end of treatment (discharge) at 6-weeks (on average), and 3-month and 6-month follow up.

Collaborators and Investigators

• Sponsor: Laura E Simons
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Laura Simons, PhD, Professor

Publications and helpful links

General Publications

• Simons LE, Harrison LE, O'Brien SF, Heirich MS, Loecher N, Boothroyd DB, Vlaeyen JWS, Wicksell RK, Schofield D, Hood KK, Orendurff M, Chan S, Lyons S. Graded exposure treatment for adolescents with chronic pain (GET Living): Protocol for a randomized controlled trial enhanced with single case experimental design. Contemp Clin Trials Commun. 2019 Sep 10;16:100448. doi: 10.1016/j.conctc.2019.100448. eCollection 2019 Dec.
• Shear D, Harrison LE, O'Brien S, Khazendar Z, Lyons S, Morgan JJ, Chan SK, Feinstein AB, Simons LE. Rapid Transition to Virtual Assessment and Treatment in an Interdisciplinary Randomized Clinical Trial for Youth With Chronic Pain: Adaptations and Implications for Future Trials. Clin J Pain. 2022 Jul 1;38(7):459-469. doi: 10.1097/AJP.0000000000001040.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2019
• Primary Completion (Actual): January 28, 2022
• Study Completion (Actual): January 28, 2022

Study Registration Dates

• First Submitted: July 28, 2018
• First Submitted That Met QC Criteria: October 4, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Chronic Pain; Musculoskeletal Pain
• Other Study ID Numbers: 39514; 1R21AR072921-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (text, tables, figures, appendices) that underlie the results reported in an article related to this trial will, after de-identification, be shared with researchers who provide a methodologically sound proposal.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Proposals should be directed to Dr. Laura Simons at lesimons@stanford.edu. To gain access, data requestors will need to sign a data usage agreement with Stanford University.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No