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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03699007
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Laura E Simons, Stanford University

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.

Condition or disease Intervention/treatment Phase
Pediatric Pain Chronic Pain, Widespread Musculoskeletal Pain Behavioral: Graded Exposure Therapy (GET Living) Behavioral: Typical Pain Management (TPM) Not Applicable

Detailed Description:
The treatment intervention to be tested in this clinical trial is Graded in-vivo Exposure Treatment (GET Living) compared to Typical Pain Management (TPM) in adolescents with chronic musculoskeletal pain. Participants will be randomized into GET Living or TPM, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain
Actual Study Start Date : January 23, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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: Typical Pain Management (TPM)
TPM 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: Typical Pain Management (TPM)
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 Outcome Measures :
  1. Pain-related Fear and Avoidance [ Time Frame: Baseline to end of treatment at 6-weeks, on average ]
    Fear of Pain Questionnaire (FOPQ-C): a 24-item validated patient-report measure of pain-related fear and avoidance. (score Min=0, Max=96; Lower score means less fear and avoidance/better outcomes.


Secondary Outcome Measures :
  1. Functional Disability [ Time Frame: Baseline to end of treatment at 6-weeks, on average ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699007


Contacts
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Contact: Marissa Heirich, BS 650-723-5814 mheirich@stanford.edu
Contact: Gillian Rush, BA 650-497-9562 gqrush@stanford.edu

Locations
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United States, California
Pediatric Pain Management Clinic - Stanford Children's Health Recruiting
Menlo Park, California, United States, 94025
Contact: Marissa Heirich, BS    650-723-5814    mheirich@stanford.edu   
Contact: Gillian Rush, BA    650-497-9562    gqrush@stanford.edu   
Principal Investigator: Laura E Simons, PhD         
Sponsors and Collaborators
Laura E Simons
Investigators
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Principal Investigator: Laura Simons, PhD Associate Professor
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Responsible Party: Laura E Simons, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03699007    
Other Study ID Numbers: 39514
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Musculoskeletal Pain
Chronic Pain
Pain
Neurologic Manifestations
Muscular Diseases
Musculoskeletal Diseases