Clinical trial NCT06365892: Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis
Official title: Effectiveness of Conditioning + Open-label Placebo for the Management of Pain in Children Who Undergo Surgical Treatment of Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Adolescent Idiopathic Scoliosis (AIS)
Keywords: Conditioning with Open-Label Placebo (COLP)
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 64
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Both arms - Open-label Placebo (COLP) and Treatment As Usual (TAU)
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effects of conditioning with open-label placebos on standard postoperative treatment for patients undergoing surgery for idiopathic scoliosis in a randomized controlled, 6-week trial with 64 AIS patients randomly assigned to one of two arms: Open-label Placebo (COLP) + treatment as usual TAU / TAU control. The study involves collecting data from your child's medical record. At each regular clinic visit, the patient clinical data will be collected by the research coordinator. Surveys will be collected including:• PROMIS for the age group 10 to 18 years.

Detailed description: Interventional (clinical trial): Subject will be randomly assigned using permuted blocks (block size of 4). Before usage, random assignments will be created, stored in sealed envelopes, and numbered (1, 2, etc.). There will be stratified randomization: Later on, stratification will be incorporated into the analysis. 32 people will be in the group taking the placebo pills in addition to standardized treatment and 32 people will be in the group with standardized treatment alone.

Hypothesis: Open-label Placebo (COLP) \< treatment as usual (TAU) control. Secondary Aims Analysis Plan: There are three secondary aims in this study.

Aim 1. To determine whether 6 weeks of Open-label Placebo (COLP) results in significantly reduced opioid consumption compared to treatment as usual. To test this aim, the investigators will conduct a t-test comparing mean opioid use over the 6 weeks of follow up. In secondary analyses, the investigators will adjust for any baseline factors including gender, age, symptom severity or type of surgery that could be a confounding variable.

1a. To determine if 6 weeks of Open-label Placebo (COLP) results in reduced opioid consumption compared to treatment as usual. Hypothesis: Open-label Placebo (COLP) \< treatment as usual (TAU) control.

Secondary Aims Analysis Plan: There are three secondary aims in this study.

Secondary Aim 1: Determine if there are significant differences in time to independence with physical therapy, length of stay, time to return to school, urinary retention, constipation, oxygen requirement, and number of contacts with medical team in Open-label Placebo (COLP) compared to treatment as usual (TAU).

Secondary Aim 2: Determine if there is an association between preoperative pain catastrophization, kinesiophobia, positive/negative affect, anxiety, and/or depression and response to Open-label Placebo (COLP) and/or treatment as usual (TAU).

Secondary Aim 3: Determine if there is an association between postoperative PROMIS scores, anxiety, and/or depression in open-label placebo (COLP) compared to treatment as usual (TAU).

Primary Objectives The primary objectives of this study are to: (1) to determine whether 6 weeks of conditioning with open-label placebo (COLP) results in reduced opioid consumption (amount and duration) compared to treatment as usual (TAU) control and (2) to determine whether 6 weeks of Open-label Placebo (COLP) compared to treatment as usual (TAU) results in different clinical outcomes.

Secondary Objectives

* To determine whether open-label placebo (COLP) affects anxiety and/or depression.
* To determine whether open-label placebo (COLP) affects length of stay, opioid side effects, time to independence with physical therapy, and/or number of contacts with medical team.
* To determine if there is an association between pain catastrophizing, kinesiophobia, and clinical outcomes.

Eligibility criteria: Inclusion Criteria:

To be eligible for enrollment, patients must meet all of the following inclusion criteria:

1. Diagnosis of idiopathic spine deformity.
2. Age \>10 and \<18 years.
3. Primary procedure.
4. Guardian provides signed and dated informed consent and understand the nature of the study sufficiently to allow completion of all study assessments.
5. Patient provides assent.
6. Fusion and fusionless instrumented spine surgery.

Exclusion Criteria:

If any of the following exclusion criteria are met, the patient is not eligible for the study:

1. Non-idiopathic scoliosis, such as neuromuscular or syndrome.
2. Revision procedure.
3. Self-reported pregnancy or planned pregnancy within the next two months.
4. Have a history of drug, excluding nicotine or caffeine, or alcohol abuse within 2 years of entry into the study
5. Already taking opioids.
6. Abnormal physical examination.
7. Inability to speak or read English
8. Patient declines participation.

Primary outcomes:
measure: The total amount of opioids consumed in oral morphine equivalents (OMEs) following surgery
timeFrame: from admission to 6 weeks post-operatively
Secondary outcomes:
measure: Weekly level of mobility and change from baseline in mobility on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Pediatric Mobility Short Form 7a at week 6.
timeFrame: weekly from admission to 6 weeks post-operatively
measure: Weekly level of anxiety and change from baseline in anxiety levels on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Anxiety Short Form 8a at week 6.
timeFrame: weekly from admission to 6 weeks post-operatively
measure: Weekly level of depressive symptoms and change from baseline in depressive symptoms on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Depressive Symptoms Short Form 8a at week 6.
timeFrame: weekly from admission to 6 weeks post-operatively
measure: The duration of time in days following surgery until patients establish Independence with Physical Therapy
timeFrame: from admission to final physical therapy assessment, up to 6 weeks
measure: The length of time in days following surgery until discharge from the hospital
timeFrame: from admission to discharge, up to 6 weeks
measure: The length of time in days following surgery until participant returns to school
timeFrame: from admission to date of return to school, up to 6 weeks post-operatively
measure: Whether participants experience urinary retention following surgery.
timeFrame: during hospitalization until discharge, up to 6 weeks
measure: Whether participants experience constipation measured by the number of days between surgery and first bowel movement
timeFrame: from admission to date of first bowel movement, up to 6 weeks post-operatively
measure: Whether participants experience an oxygen requirement and the duration of the requirement following surgery.
timeFrame: during hospitalization until discharge, up to 6 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Mohammad Diab, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Theologis AA, Wu HH, Oeding JF, Diab M. Costs of revision operations for distal junctional kyphosis following thoracic posterior spinal fusion for adolescent idiopathic scoliosis. Eur Spine J. 2024 Jun;33(6):2504-2511. doi: 10.1007/s00586-024-08160-6. Epub 2024 Feb 20.
citation: Oeding JF, Siu J, O'Donnell J, Wu HH, Allahabadi S, Saggi S, Flores M, Brown K, Baldwin A, Diab M. Combined Anterior Thoracic Vertebral Body Tethering and Posterior Lumbar Tethering Results in Quicker Return to Sport and Activity Compared to Posterior Spinal Instrumented Fusion in Patients with Adolescent Idiopathic Scoliosis. Global Spine J. 2025 Mar;15(2):1068-1076. doi: 10.1177/21925682231222887. Epub 2023 Dec 14.
citation: Siu JW, Wu HH, Saggi S, Allahabadi S, Katyal T, Diab M. Radiographic and perioperative outcomes following anterior thoracic vertebral body tethering and posterior lumbar spine tethering: a pilot series. Spine Deform. 2023 Nov;11(6):1399-1408. doi: 10.1007/s43390-023-00717-7. Epub 2023 Jun 25.
citation: O'Donnell JM, Gornitzky AL, Wu HH, Furie KS, Diab M. Anterior vertebral body tethering for adolescent idiopathic scoliosis associated with less early post-operative pain and shorter recovery compared with fusion. Spine Deform. 2023 Jul;11(4):919-925. doi: 10.1007/s43390-023-00661-6. Epub 2023 Feb 21.
citation: Siu JW, Wu HH, Saggi S, Allahabadi S, Katyal T, Diab M. Perioperative Outcomes of Open Anterior Vertebral Body Tethering and Instrumented Posterior Spinal Fusion for Skeletally Immature Patients With Idiopathic Scoliosis. J Pediatr Orthop. 2023 Mar 1;43(3):143-150. doi: 10.1097/BPO.0000000000002320. Epub 2022 Dec 6.
citation: Theologis AA, Wu HH, Diab M. Thoracic posterior spinal instrumented fusion vs. thoracic anterior spinal tethering for adolescent idiopathic scoliosis with a minimum of 2-year follow-up: a cost comparison of index and revision operations. Spine Deform. 2023 Mar;11(2):359-366. doi: 10.1007/s43390-022-00586-6. Epub 2022 Sep 21.
citation: Allahabadi S, Wu HH, Allahabadi S, Woolridge T, Kohn MA, Diab M. Concurrent and overlapping surgery: perspectives from surgeons on spinal posterior instrumented fusion for adolescent idiopathic scoliosis. J Child Orthop. 2021 Dec 1;15(6):589-595. doi: 10.1302/1863-2548.15.210142.
citation: Iriondo C, Mehany S, Shah R, Bharadwaj U, Bahroos E, Chin C, Diab M, Pedoia V, Majumdar S. Institution-wide shape analysis of 3D spinal curvature and global alignment parameters. J Orthop Res. 2022 Aug;40(8):1896-1908. doi: 10.1002/jor.25213. Epub 2021 Nov 29.
citation: Zaid M, Diab M. Surgeon Suicide Remains a Critical Issue for the Orthopaedic Profession. J Bone Joint Surg Am. 2021 Oct 20;103(20):e81. doi: 10.2106/JBJS.20.01125. No abstract available.
citation: Hung NJ, Theologis AA, Courtier JL, Harmon D, Diab M. Ureteral injury following anterior thoracolumbar spinal instrumented fusion for adolescent idiopathic scoliosis: a case report with CT angiography analysis of surgically relevant anatomy. Spine Deform. 2021 Nov;9(6):1691-1698. doi: 10.1007/s43390-021-00363-x. Epub 2021 Jun 1.