Clinical trial NCT03699007: GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain
Official title: GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Pain
Chronic Pain, Widespread
Musculoskeletal Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2018-10-09
Enrollment: 68
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Adolescents will be randomized to either GET Living or TPM and stratified on fear (moderate/high; FOPQ-C: moderate \[35-49\] high \[50-96\]) and disability (moderate/high; moderate \[13-29\] severe \[30-60\]), to minimize the possibility of imbalance between the two treatment arms. To allow the use of small blocks while minimizing the probability of a blinded staff member predicting the next assignment we will use blocks of size two and four and randomly choose block sizes.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Pain-related Fear and Avoidance
timeFrame: Baseline to end of treatment (discharge) at 6-weeks (on average), and 3-month and 6-month follow up.
Secondary outcomes:
measure: Functional Disability
timeFrame: Baseline to end of treatment (discharge) at 6-weeks (on average), and 3-month and 6-month follow up.
Other outcomes:
Locations:
city: Menlo Park
country: United States
facility: Pediatric Pain Management Clinic - Stanford Children's Health
state: California
Study officials:
affiliation: Professor
name: Laura Simons, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.