Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04637802
Other study ID # UH3HD102038
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 29, 2020
Est. completion date August 2025

Study information

Verified date August 2022
Source Seattle Children's Hospital
Contact Jennifer Rabbitts, MD
Phone 206-884-1361
Email jennifer.rabbitts@seattlechildrens.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized controlled trial to test effectiveness of the SurgeryPal intervention vs. education control to improve acute and chronic pain and health outcomes in youth undergoing major musculoskeletal surgery. Youth will be randomized on an individual level using a factorial design to SurgeryPal or Education during 2 phases of intervention: 1) pre-operative phase (4 week duration delivered over the 4 weeks leading up to surgery), and 2) post-operative phase (4 week duration following surgery). Thus there will be 4 treatment arms. Participants will undergo 4 assessments, independent of their treatment assignment: T1: Baseline (pre-randomization); T2: acute post-surgery outcomes (daily assessment of acute outcomes beginning day 1 through day 14 after hospital discharge from surgery); T3: Post-surgery follow-up (assessment of outcomes at 3-months post-surgery); T4: Final post-surgery follow-up (assessment of outcomes at 6-months post-surgery).


Description:

Major musculoskeletal surgeries are associated with particularly high prevalence of both acute and chronic post-surgical pain (CPSP), with 80% of youth reporting intense acute pain after hospital discharge, and up to half reporting CPSP up to one year after spine surgery. Interventions to improve recovery and reduce pain after surgery have potential to interrupt a negative trajectory of suffering and disability associated with chronic pain. Our specific aims are: Primary: (1) Determine effectiveness of a pre-operative mHealth psychosocial intervention to improve acute pain outcomes in adolescents undergoing major musculoskeletal surgery, (2) Determine effectiveness of a post-operative mHealth psychosocial intervention to improve chronic pain outcomes at 3 months in adolescents undergoing major musculoskeletal surgery, (3) Determine the combined effects of pre- and post-operative psychosocial intervention on chronic pain outcomes. Secondary: (1) Determine effectiveness of pre-operative psychosocial intervention to reduce opioid use during the 14 days following hospital discharge, (2) Determine effectiveness of psychosocial intervention to improve health-related quality of life following surgery.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date August 2025
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria: Teen - 12 to 18 years old at the time of enrollment - Undergoing scheduled spinal fusion surgery (eligible indications: juvenile/adolescent idiopathic scoliosis, congenital scoliosis, spondylolisthesis or kyphosis) Parent/Caregiver - Parent or legal guardian of child who meets study criteria Exclusion Criteria: Teen - Does not speak or understand English - Has severe learning disability, cognitive impairment or intellectual delay (i.e. unable to read at 5th grade level) - Does not have access to a smart device (smartphone, iPad or tablet; Teens can borrow an iPad from the study team if one is available) - Recent psychiatric admission (in the past 30 days) - Severe systemic disease (neuromuscular scoliosis, cancer) - On a regular treatment regimen for a severe chronic medical condition - Prior major surgery (open surgery such as heart, lung, brain, abdominal surgery, or prior spine surgery) - Diagnosed chronic musculoskeletal pain condition (e.g. complex regional pain syndrome, fibromyalgia, widespread musculoskeletal pain) Parent/Caregiver - Does not speak or understand English - Does not have access to a smart device (smartphone, iPad or tablet)

Study Design


Intervention

Behavioral:
CBT (SurgeryPal)
The SurgeryPal intervention is a cognitive-behavioral program for youth undergoing major surgery. SurgeryPal is delivered in two 4-week phases: the pre-operative phase, and the post-operative phase. Each phase consists of 3 separate treatment modules for youth and parents, which teach cognitive and behavioral coping skills to target known psychosocial and behavioral risk factors (i.e. anxiety/distress and sleep disturbance) for poorer postsurgical outcomes, and provide training in pain self-management skills. Pre-operative modules include: 1) Preparing for surgery, 2) Coping with stress before surgery, and 3) Getting ready for the hospital. Postoperative modules include: 1) Coping at home after surgery, 2) Return to activities and school, and 3) Long-term recovery. Modules are self-guided and interactive, and focus on phases of preparation and recovery from surgery. The goal of the program is to reduce pain and enhance quality of life following surgery in youth.
Education
The patient education website will serve as the active comparator. The purpose is to control for time, attention, and online usage. Youth and parents will be provided access to an education website containing information about pediatric surgery at the same time interval as the active intervention; however, there will be no exposure to cognitive and behavioral coping skills. Similar to the CBT condition, the presurgery period of Education will be administered for one month prior to surgery and the postsurgery period will be administered for one month after the post-discharge assessment.

Locations

Country Name City State
United States Seattle Children's Hospital Seattle Washington

Sponsors (6)

Lead Sponsor Collaborator
Seattle Children's Hospital Connecticut Children's Medical Center, Duke University, Johns Hopkins University, University of Utah, Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-surgical pain intensity and interference The Brief Pain Inventory (BPI) has 2 scales: pain intensity (4 items) and pain interference (7 items). Items are averaged to yield scale scores, ranging from 0 to 10, with higher scores indicating greater pain intensity or interference. The 24 hour (short) version of this measure will be completed via REDCap daily for 14 days post-hospital discharge (beginning on day 1 after hospital discharge, and ending up to 3-weeks post-surgery). Up to 3 weeks post-surgery
Primary Chronic pain intensity and interference The Brief Pain Inventory (BPI) has 2 scales: pain intensity (4 items) and pain interference (7 items). Items are averaged to yield scale scores, ranging from 0 to 10, with higher scores indicating greater pain intensity or interference. The 24 hour (short) version of this measure will be completed via REDCap daily for 7 days at 3 months after the participant's surgery date. 3 months post-surgery
Secondary Change in health-related quality of life The Pediatric Quality of Life Inventory (Peds-QL) 15-item short form assesses several domains of functioning, including physical, social, emotional, and academic functioning. The PedsQL is widely used and demonstrates good reliability for both the parent and child self-report measures. Scale scores range from 0 to 100. Higher scores indicate fewer difficulties (better) health-related quality of life. Subscales of physical and psychosocial health will be used in analyses. Baseline, 3-months post-surgery, 6-months post-surgery
Secondary Change in opioid use Youth will report medication use on the Brief Pain Inventory (BPI), including selecting medication name from a dropdown list (opioid, acetaminophen, anti-inflammatory, other). Number of days of opioid use will be used in analyses. Baseline, Up to 3 weeks post-surgery, 3-months post-surgery, 6-months post-surgery
Secondary Change in opioid misuse The American Psychiatric Association (APA) Adapted National Institute for Drug Abuse (NIDA) Modified Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Level 2 Tool (Teen Report) recommended by the National Institute on Drug Abuse for substance use screening in adolescents, will be used to assess alcohol, smoking, substance, and opioid use. Additional questions on reasons for misuse (e.g. to treat pain, to get high, etc.) and source of opioids (e.g. prescription, from a friend or relative) will be collected using the corresponding questions and response options used in the National Survey on Drug Use and Health. Baseline, 3-months post-surgery, 6-months post-surgery
Secondary Change in psychosocial distress The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Emotional Distress Scales include an 8-item scale of anxiety that assesses fear (e.g., fearfulness), anxious misery (e.g., worry) and hyperarousal (e.g., nervousness) and 8-item scale of depressive symptoms that evaluates negative mood, view of self and social cognitions. Response options range from 1 (Never) to 5 (Almost Always). Raw scores for anxiety and depression are obtained by summing the corresponding items' response values, and range from 8 to 40 with higher scores indicating higher distress. Baseline, 3-months post-surgery, 6-months post-surgery
Secondary Change in mental health Parents and teens will self-report on the Patient Health Questionnaire-4, a 4 item screening measure of general anxiety and depressive symptoms. Response options range from 0 (Not at all) to 3 (Nearly Every Day). Total scores are calculated by summing items, for a total score ranging from 0 to 12, with higher scores indicating greater anxiety and depressive symptoms. Baseline, 3-months post-surgery, 6-months post-surgery
Secondary Change in sleep quality The Adolescent Sleep Wake Scale 10-item version (Teen Report) is a 10-item measure assesses self-reported sleep quality. Scale scores range from 1 to 6 with higher scores indicating better sleep quality. Four additional items assess sleep duration on weekdays and weekends. Baseline, 3-months post-surgery, 6-months post-surgery
Secondary Change in pain catastrophizing The Pain Catastrophizing Scale - Child Version and Parent Version is a Self-report 13 item measures that assess child pain catastrophizing and parent's catastrophizing about child's pain, respectively. Total scores range from 0 to 52 with higher scores indicating greater pain catastrophizing. Baseline, 3-months post-surgery
Secondary Global pain severity The Patient Global Impression of Severity Scale (PGIS), Teen Report is a 1-item measure that assesses adolescent's self-reported global impression of pain severity. Response options range from 0 (none) to 3 (severe) with higher scores indicating higher pain severity. Up to 3 weeks post-surgery, 3-months post-surgery, 6-months post-surgery
See also
  Status Clinical Trial Phase
Recruiting NCT03883022 - Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery N/A
Active, not recruiting NCT04542577 - PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D
Recruiting NCT04477447 - PMCF Study on the Safety and Performance of CESPACE 3D
Completed NCT02558621 - New Robotic Assistance System for Spinal Fusion Surgery N/A
Terminated NCT01461005 - A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS) N/A
Completed NCT00405691 - Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis Phase 3
Completed NCT00205101 - Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion
Enrolling by invitation NCT04204135 - The Course of Hip Flexion Weakness Following LLIF or ALIF
Recruiting NCT05238740 - Comparison of Standalone Anterior Lumbar Interbody Fusion (ALIF) L5/S1 Performed With Either rhBMP-2 or ViviGen® N/A
Completed NCT02931279 - PASS OCT® Post-market Clinical Follow-up
Not yet recruiting NCT02805985 - Post-market Surveillance Study of FLXfit™ TLIF Interbody Fusion Device N/A
Completed NCT02966639 - Validation of Appropriateness Criteria for the Surgical Treatment of Lumbar Degenerative Spondylolisthesis
Active, not recruiting NCT02057744 - MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries
Completed NCT01711203 - The Addition of a Pilates Program for Short-Term Improvements in Patients With Spondylolysis or Spondylolisthesis N/A
Completed NCT00549913 - Study of 3 Doses of NeoFuse Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion (PLF) Phase 1/Phase 2
Terminated NCT00254852 - Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft N/A
Terminated NCT00095095 - Lumbar Interbody Fusion Using the Telamon® Peek™ Versus the Telamon® Hydrosorb™ Fusion Device Phase 4
Active, not recruiting NCT03956537 - PMCF Neo Pedicle Screw and Cage Systems
Recruiting NCT05182489 - Adaptix RCT Evaluating Adaptix™ Versus PEEK Cages N/A
Completed NCT02884440 - Transverse Abdominis Plane Block for Anterior Approach Spine Surgery Phase 2