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

Musculoskeletal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03699007
• Other study ID #: 39514
• Secondary ID: 1R21AR072921-01A
• Status: Completed
• Phase: N/A
• Start date: January 23, 2019
• Est. completion date: January 28, 2022

Study information

• Verified date: July 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 28, 2022
• Est. primary completion date: January 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain, Widespread
• Musculoskeletal Pain
• Pediatric Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Pediatric Pain Management Clinic - Stanford Children's Health	Menlo Park	California

Sponsors (2)

Lead Sponsor	Collaborator
Laura E Simons	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 Implica — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.