Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2026-01-01 @ 9:36 PM
Study NCT ID:
NCT06365892
Status:
RECRUITING
Last Update Posted:
2025-10-06
First Post:
2024-04-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Blinding of patients and providers will not be feasible due to the nature of the study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Both arms - Open-label Placebo (COLP) and Treatment As Usual (TAU)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2024-04-09', 'studyFirstSubmitQcDate': '2024-04-09', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The total amount of opioids consumed in oral morphine equivalents (OMEs) following surgery', 'timeFrame': 'from admission to 6 weeks post-operatively', 'description': 'Oral morphine equivalents (OMEs) are values that represent the potency of an opioid dose relative to morphine. Using OMEs provides a standardized method for converting between various opiate medications. Each oral opioid dose is a 5mg Oxycodone tablet prescribed 6 times per day pro re nata. Participants will record the number of oral opioids taken each day for 6 weeks following surgery beginning on Post-op Day 1 (POD1). This data will be collected and converted into OMEs for comparison.'}], 'secondaryOutcomes': [{'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', 'description': 'the PROMIS Pediatric Mobility SF 7a is a validated, self-reported instrument that consists of 7 items rating mobility on average over the past 7 days from 4 (With no trouble) to 0 (not able to do). Weekly level of mobility = mobility score reported at each week Change = (Week 6 Score - Baseline Score).'}, {'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', 'description': 'the PROMIS Anxiety SF 8a is a validated, self-reported instrument that consists of 8 items rating anxiety on average over the past 7 days from 1 (never) to 5 (almost always). Weekly level of anxiety = anxiety score reported at each week Change = (Week 6 Score - Baseline Score).'}, {'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', 'description': 'the PROMIS Depressive Symptoms SF 8a is a validated, self-reported instrument that consists of 8 items rating depressive symptoms on average over the past 7 days from 1 (never) to 5 (almost always).\n\nWeekly level of depressive symptoms = depressive symptoms score reported at each week Change = (Week 6 Score - Baseline Score).'}, {'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', 'description': 'Participants will be treated by physical therapy services after surgery until their physical therapist determines that they no longer require physical therapy services. Duration of time to independence with physical therapy is equal to the POD # where physical therapist determines formal PT is no longer required.'}, {'measure': 'The length of time in days following surgery until discharge from the hospital', 'timeFrame': 'from admission to discharge, up to 6 weeks', 'description': 'Participants will be admitted to the hospital following surgery until they are cleared for discharge from a medical standpoint.\n\nLength of stay = POD # that patient is discharged'}, {'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', 'description': 'Participants will record the date on which they return to school after surgery. The POD # on date of return to school = the length of time to return to school. The amount of time it takes to return to school can be used as a proxy for whether participants are struggling with their pain or not.'}, {'measure': 'Whether participants experience urinary retention following surgery.', 'timeFrame': 'during hospitalization until discharge, up to 6 weeks', 'description': 'Participants will be assessed in hospital to determine whether or not they experience urinary retention post-surgery, a potential side effect of opioid consumption. The urinary retention determination will be a yes/no answer.'}, {'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', 'description': 'Participants will record the number of days between surgery and first bowel movement to assess whether they experience constipation, a potential side effect of opioid consumption.'}, {'measure': 'Whether participants experience an oxygen requirement and the duration of the requirement following surgery.', 'timeFrame': 'during hospitalization until discharge, up to 6 weeks', 'description': 'Participants will be assessed in hospital for whether or not they have an oxygen requirement and the duration of requirement. The oxygen requirement will be a yes/no answer. If yes, the number of days that oxygen is required will be recorded for the duration.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Conditioning with Open-Label Placebo (COLP)'], 'conditions': ['Adolescent Idiopathic Scoliosis (AIS)']}, 'referencesModule': {'references': [{'pmid': '27755279', 'type': 'BACKGROUND', 'citation': 'Carvalho C, Caetano JM, Cunha L, Rebouta P, Kaptchuk TJ, Kirsch I. Open-label placebo treatment in chronic low back pain: a randomized controlled trial. Pain. 2016 Dec;157(12):2766-2772. doi: 10.1097/j.pain.0000000000000700.'}, {'pmid': '26840547', 'type': 'BACKGROUND', 'citation': 'Blease C, Colloca L, Kaptchuk TJ. Are open-Label Placebos Ethical? Informed Consent and Ethical Equivocations. Bioethics. 2016 Jul;30(6):407-14. doi: 10.1111/bioe.12245. Epub 2016 Feb 3.'}, {'pmid': '33594150', 'type': 'BACKGROUND', 'citation': 'von Wernsdorff M, Loef M, Tuschen-Caffier B, Schmidt S. Effects of open-label placebos in clinical trials: a systematic review and meta-analysis. Sci Rep. 2021 Feb 16;11(1):3855. doi: 10.1038/s41598-021-83148-6.'}, {'pmid': '29610294', 'type': 'BACKGROUND', 'citation': 'Kirchhof J, Petrakova L, Brinkhoff A, Benson S, Schmidt J, Unteroberdorster M, Wilde B, Kaptchuk TJ, Witzke O, Schedlowski M. Learned immunosuppressive placebo responses in renal transplant patients. Proc Natl Acad Sci U S A. 2018 Apr 17;115(16):4223-4227. doi: 10.1073/pnas.1720548115. Epub 2018 Apr 2.'}, {'pmid': '20028830', 'type': 'BACKGROUND', 'citation': 'Ader R, Mercurio MG, Walton J, James D, Davis M, Ojha V, Kimball AB, Fiorentino D. Conditioned pharmacotherapeutic effects: a preliminary study. Psychosom Med. 2010 Feb;72(2):192-7. doi: 10.1097/PSY.0b013e3181cbd38b. Epub 2009 Dec 22.'}, {'pmid': '22284159', 'type': 'BACKGROUND', 'citation': 'Doering BK, Rief W. Utilizing placebo mechanisms for dose reduction in pharmacotherapy. Trends Pharmacol Sci. 2012 Mar;33(3):165-72. doi: 10.1016/j.tips.2011.12.001. Epub 2012 Jan 25.'}, {'pmid': '20495473', 'type': 'BACKGROUND', 'citation': 'Sandler AD, Glesne CE, Bodfish JW. Conditioned placebo dose reduction: a new treatment in attention-deficit hyperactivity disorder? J Dev Behav Pediatr. 2010 Jun;31(5):369-75. doi: 10.1097/DBP.0b013e3181e121ed.'}, {'pmid': '35099543', 'type': 'BACKGROUND', 'citation': 'Nurko S, Saps M, Kossowsky J, Zion SR, Di Lorenzo C, Vaz K, Hawthorne K, Wu R, Ciciora S, Rosen JM, Kaptchuk TJ, Kelley JM. Effect of Open-label Placebo on Children and Adolescents With Functional Abdominal Pain or Irritable Bowel Syndrome: A Randomized Clinical Trial. JAMA Pediatr. 2022 Apr 1;176(4):349-356. doi: 10.1001/jamapediatrics.2021.5750.'}, {'pmid': '33449503', 'type': 'BACKGROUND', 'citation': 'Flowers KM, Patton ME, Hruschak VJ, Fields KG, Schwartz E, Zeballos J, Kang JD, Edwards RR, Kaptchuk TJ, Schreiber KL. Conditioned open-label placebo for opioid reduction after spine surgery: a randomized controlled trial. Pain. 2021 Jun 1;162(6):1828-1839. doi: 10.1097/j.pain.0000000000002185.'}, {'pmid': '40536435', 'type': 'DERIVED', 'citation': 'Furie KS, James K, Kaptchuk TJ, Diab M. Effectiveness of conditioning + open-label placebo for post-operative pain management in adolescent idiopathic scoliosis. Pain Manag. 2025 Jul;15(7):363-371. doi: 10.1080/17581869.2025.2520148. Epub 2025 Jun 19.'}], 'seeAlsoLinks': [{'url': 'https://profiles.ucsf.edu/mohammad.diab', 'label': 'Mohammad Diab, MD'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nHypothesis: Open-label Placebo (COLP) \\< treatment as usual (TAU) control. Secondary Aims Analysis Plan: There are three secondary aims in this study.\n\nAim 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.\n\n1a. 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.\n\nSecondary Aims Analysis Plan: There are three secondary aims in this study.\n\nSecondary 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).\n\nSecondary 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).\n\nSecondary 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).\n\nPrimary 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.\n\nSecondary Objectives\n\n* To determine whether open-label placebo (COLP) affects anxiety and/or depression.\n* 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.\n* To determine if there is an association between pain catastrophizing, kinesiophobia, and clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTo be eligible for enrollment, patients must meet all of the following inclusion criteria:\n\n1. Diagnosis of idiopathic spine deformity.\n2. Age \\>10 and \\<18 years.\n3. Primary procedure.\n4. Guardian provides signed and dated informed consent and understand the nature of the study sufficiently to allow completion of all study assessments.\n5. Patient provides assent.\n6. Fusion and fusionless instrumented spine surgery.\n\nExclusion Criteria:\n\nIf any of the following exclusion criteria are met, the patient is not eligible for the study:\n\n1. Non-idiopathic scoliosis, such as neuromuscular or syndrome.\n2. Revision procedure.\n3. Self-reported pregnancy or planned pregnancy within the next two months.\n4. Have a history of drug, excluding nicotine or caffeine, or alcohol abuse within 2 years of entry into the study\n5. Already taking opioids.\n6. Abnormal physical examination.\n7. Inability to speak or read English\n8. Patient declines participation.'}, 'identificationModule': {'nctId': 'NCT06365892', 'briefTitle': 'Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Effectiveness of Conditioning + Open-label Placebo for the Management of Pain in Children Who Undergo Surgical Treatment of Idiopathic Scoliosis', 'orgStudyIdInfo': {'id': '22-36548'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open-label Placebo (COLP)', 'description': 'Placebo will be supplied as a 330mg tablet (manufactured by Consolidated Midland Corporation). Each oral opioid dose is a 5mg Oxycodone tablet. Patients will take placebo with each oral opioid intake and 3 additional times per day beginning on POD 1. Investigator shall never prescribe ibuprofen. Investigator shall always prescribe Tylenol 625mg every 8hrs (PRN).', 'interventionNames': ['Other: open-label placebo', 'Other: Treatment as usual']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment As Usual (TAU)', 'description': 'Treatment As Usual (TAU) subjects will receive equal access to opioid and non-opioid analgesics. The preferred oral opioid dose is a 5mg Oxycodone pill. Subjects will take a placebo with each oral opioid dose and additional three times per day beginning on POD 1.', 'interventionNames': ['Other: Treatment as usual']}], 'interventions': [{'name': 'open-label placebo', 'type': 'OTHER', 'otherNames': ['Inactive drug, Inactive medicine, Inactive substance, Sugar Pill Test Substance'], 'description': 'Placebo will be supplied as a 330mg tablet (manufactured by Consolidated Midland Corporation). Patients will take placebo with each oral opioid intake and 3 additional times per day beginning on POD 1.', 'armGroupLabels': ['Open-label Placebo (COLP)']}, {'name': 'Treatment as usual', 'type': 'OTHER', 'description': 'Each oral opioid dose is a 5mg Oxycodone tablet. Investigator shall never prescribe ibuprofen. Investigator shall always prescribe Tylenol 625mg every 8hrs (PRN).', 'armGroupLabels': ['Open-label Placebo (COLP)', 'Treatment As Usual (TAU)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mohammad Diab, MD', 'role': 'CONTACT', 'email': 'Mohammad.Diab@ucsf.edu', 'phone': '415-514-1519'}, {'name': 'Mohammad Diab, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Mohammad Diab, MD', 'role': 'CONTACT', 'email': 'mohammad.diab@ucsf.edu', 'phone': '415-514-1519'}, {'name': 'Tripta Rughwani', 'role': 'CONTACT', 'email': 'tripta.rughwani@ucsf.edu'}], 'overallOfficials': [{'name': 'Mohammad Diab, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}