Clinical trial NCT04637802: Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery
Official title: Effectiveness of an mHealth Psychosocial Intervention to Prevent Transition From Acute to Chronic Postsurgical Pain in Adolescents
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Juvenile; Scoliosis
Scoliosis Idiopathic
Scoliosis; Adolescence
Scoliosis;Congenital
Kyphosis
Spondylolisthesis
Keywords: Psychosocial Intervention
Spinal Fusion Surgery
Chronic Pain
Acute Pain
Adolescent
Randomized controlled trial
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Duke University
name: University of Utah
name: Vanderbilt University
name: Johns Hopkins University
name: Connecticut Children's Medical Center
First posted: 2020-11-20
Enrollment: 433
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Randomized and double-blinded controlled trial of cognitive-behavioral intervention vs education at two phases (pre-operative and post-operative)
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Post-surgical pain intensity and interference
timeFrame: Up to 3 weeks post-surgery
measure: Chronic pain intensity and interference
timeFrame: 3 months post-surgery
Secondary outcomes:
measure: Change in health-related quality of life
timeFrame: Baseline, 3-months post-surgery, 6-months post-surgery
measure: Change in opioid use
timeFrame: Baseline, Up to 3 weeks post-surgery, 3-months post-surgery, 6-months post-surgery
measure: Change in opioid misuse
timeFrame: Baseline, 3-months post-surgery, 6-months post-surgery
measure: Change in psychosocial distress
timeFrame: Baseline, 3-months post-surgery, 6-months post-surgery
measure: Change in mental health
timeFrame: Baseline, 3-months post-surgery, 6-months post-surgery
measure: Change in sleep quality
timeFrame: Baseline, 3-months post-surgery, 6-months post-surgery
measure: Change in pain catastrophizing
timeFrame: Baseline, 3-months post-surgery
measure: Global pain severity
timeFrame: Up to 3 weeks post-surgery, 3-months post-surgery, 6-months post-surgery
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Jennifer Rabbitts, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seattle Children's Hospital
name: Tonya Palermo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rabbitts JA, Zhou C, de la Vega R, Aalfs H, Murray CB, Palermo TM. 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. 2021 Jul 30;22(1):506. doi: 10.1186/s13063-021-05421-3.