Eligibility
< 65
All Sexes
What conditions do you have?
Select
Study Summary
This trial is testing whether the SurgeryPal intervention can improve acute and chronic pain and health outcomes in youth undergoing major musculoskeletal surgery, compared to an education control. Participants will be randomized to one of four treatment arms, and will be assessed four times over the course of the study.
Eligible Conditions
- Kyphosis
- Scoliosis Idiopathic
- Scoliosis; Juvenile
- Olisthesis
- Scoliosis; Adolescence
- Scoliosis;Congenital
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 8 Secondary · Reporting Duration: Up to 3 weeks post-surgery, 3-months post-surgery, 6-months post-surgery
3 months post-surgery
Chronic pain intensity and interference
Baseline, 3-months post-surgery
Change in pain catastrophizing
Baseline, 3-months post-surgery, 6-months post-surgery
Change in health-related quality of life
Change in mental health
Change in opioid misuse
Change in psychosocial distress
Change in sleep quality
Week 3
Change in opioid use
Week 3
Post-surgical pain intensity and interference
Week 3
Global pain severity
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
Pre-operative and Post-operative Education intervention
1 of 4
Pre-operative CBT intervention (SurgeryPal), Post-operative Education interventi...
1 of 4
Pre-operative Education intervention, Post-operative CBT intervention (SurgeryPa...
1 of 4
Pre-operative and Post-operative CBT intervention (SurgeryPal)
1 of 4
Active Control
Experimental Treatment
500 Total Participants · 4 Treatment Groups
Primary Treatment: CBT (SurgeryPal) · No Placebo Group · N/A
Pre-operative CBT intervention (SurgeryPal), Post-operative Education interventionExperimental Group · 2 Interventions: CBT (SurgeryPal), Education · Intervention Types: Behavioral, Behavioral
Pre-operative Education intervention, Post-operative CBT intervention (SurgeryPal)Experimental Group · 2 Interventions: CBT (SurgeryPal), Education · Intervention Types: Behavioral, Behavioral
Pre-operative and Post-operative CBT intervention (SurgeryPal)
Behavioral
Experimental Group · 1 Intervention: CBT (SurgeryPal) · Intervention Types: BehavioralPre-operative and Post-operative Education intervention
Behavioral
ActiveComparator Group · 1 Intervention: Education · Intervention Types: BehavioralTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Education
2017
Completed Phase 3
~4010
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 weeks post-surgery, 3-months post-surgery, 6-months post-surgery
Who is running the clinical trial?
University of UtahOTHER
990 Previous Clinical Trials
1,768,448 Total Patients Enrolled
Vanderbilt UniversityOTHER
682 Previous Clinical Trials
6,130,896 Total Patients Enrolled
Duke UniversityOTHER
2,154 Previous Clinical Trials
3,179,313 Total Patients Enrolled
Seattle Children's HospitalLead Sponsor
262 Previous Clinical Trials
5,185,012 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,055 Previous Clinical Trials
30,974,481 Total Patients Enrolled
1 Trials studying Kyphosis
48 Patients Enrolled for Kyphosis
Connecticut Children's Medical CenterOTHER
59 Previous Clinical Trials
29,227 Total Patients Enrolled
Tonya Palermo, PhDPrincipal InvestigatorSeattle Children's Hospital
2 Previous Clinical Trials
403 Total Patients Enrolled
Jennifer Rabbitts, MDPrincipal Investigator - Seattle Children's Hospital
Seattle Children's Hospital
Eligibility Criteria
Age < 65 · All Participants · 5 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are a teen.
You are a parent or caregiver.
You are 12 to 18 years old.
You are the parent or legal guardian of a child who meets study criteria.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- Rabbitts, Jennifer A., Chuan Zhou, Rocio de la Vega, Homer Aalfs, Caitlin B. Murray, and Tonya M. Palermo. 2021. “A Digital Health Peri-operative Cognitive-behavioral Intervention to Prevent Transition from Acute to Chronic Postsurgical Pain in Adolescents Undergoing Spinal Fusion (surgerypaltm): Study Protocol for a Multisite Randomized Controlled Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-021-05421-3.
- Rabbitts, Jennifer A., Chuan Zhou, Rocio de la Vega, Homer Aalfs, Caitlin B. Murray, and Tonya M. Palermo. 2021. “A Digital Health Peri-operative Cognitive-behavioral Intervention to Prevent Transition from Acute to Chronic Postsurgical Pain in Adolescents Undergoing Spinal Fusion (surgerypaltm): Study Protocol for a Multisite Randomized Controlled Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-021-05421-3.
- Jennifer Rabbitts, MBChB 2020. "Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04637802.
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