Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-29 @ 6:57 PM
Study NCT ID:
NCT05121961
Status:
RECRUITING
Last Update Posted:
2024-12-05
First Post:
2021-10-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment for Sacroiliac Joint Pain Using Platelet-rich Plasma (PRP) Versus Steroid/Anesthetic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-14', 'size': 635539, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-03T15:25', 'hasProtocol': True}, {'date': '2021-03-18', 'size': 185303, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-04-16T14:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Patients will be blinded to which injectate they received.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-blind randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2021-10-20', 'studyFirstSubmitQcDate': '2021-11-03', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Rating Scale', 'timeFrame': 'Change between baseline and 3-months post-intervention', 'description': 'Validated pain scale rating pain on a scale of 0 through 10. 0 for no pain, and 10 for the highest pain the patient can imagine.'}], 'secondaryOutcomes': [{'measure': 'Modified Oswestry Disability Questionnaire', 'timeFrame': 'Change between baseline and 3-months post-intervention', 'description': 'Validated questionnaire used to evaluate function in patients with low back pain. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.'}, {'measure': 'Short-Form 12 Survey', 'timeFrame': 'Change between baseline and 3-months post-intervention', 'description': 'Validated survey used to evaluate function in patients with low back pain. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.'}, {'measure': 'Functional testing', 'timeFrame': 'Change between baseline and 3-months post-intervention', 'description': '2 validated tests for low back pain "get up and go," "5 time sit to stand." Shorter times indicate better physical function, and longer times indicate poorer physical function.'}, {'measure': 'Opiate/pain medication usage questionnaire', 'timeFrame': 'Change between baseline and 3-months post-intervention', 'description': 'Questionnaire on type, dose, and frequency of pain medications being used by the patient. All opiates will be converted to the morphine milligram equivalent scale with lower values indicating lower opiate content and higher values indicating higher opiate content'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain', 'Sacroiliac Joint Synovitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if platelet-rich plasma is superior to steroid/anesthetic for the treatment of sacroiliac joint pain.', 'detailedDescription': 'All patients with sacroiliac joint pain diagnosed by a back pain specialist will undergo physical examination maneuvers and a test lidocaine injection of the joint. Patients who meet eligibility requirements will be randomized in a single-blind randomized controlled manner with a 50% chance of receiving platelet-rich plasma versus steroid/anesthetic injection of the sacroiliac joint(s).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (\\>18 y/o) males and females referred for therapeutic injection to the investigators spine interventional service by a physiatrist or pain anesthesiologist with a clinical diagnosis of SIJ pain confirmed by history\n* 50% or greater reduction in pain by a diagnostic anesthetic block using no more than 1.5 cc 2% lidocaine performed under imaging guidance by a pain interventionalist (PM\\&R, Pain Anesthesia, or Neuroradiology Spine Intervention).\n* Baseline pain must be \\>/=4 by numeric rating scale (NRS), at least 6 weeks in chronicity, and must not be multi-factorial (related to radiculopathy or axial pain localizing elsewhere) by physical examination or confounding medical history (infection, inflammatory spondyloarthropathy, or osseous metastatic disease).\n\nExclusion Criteria:\n\n* SIJ steroid treatment within the prior 6 months.\n* Patients with a history of infection currently on antibiotic therapy\n* Usage of systemic immunosuppressants\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05121961', 'briefTitle': 'Treatment for Sacroiliac Joint Pain Using Platelet-rich Plasma (PRP) Versus Steroid/Anesthetic', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Treatment for Sacroiliac Joint Pain Using Platelet-rich Plasma (PRP) Regenerative Therapy: A Randomized Controlled Trial in Comparison With Steroid/Anesthetic Injection With Advanced MR Analysis', 'orgStudyIdInfo': {'id': 'RSCH1923'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Platelet-rich Plasma', 'description': 'Patients will receive an intra-articular injection 3 mL of autologous platelet-rich plasma in the sacroiliac joint.', 'interventionNames': ['Procedure: Sacroiliac intra-articular injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Steroid/Anesthetic', 'description': 'Patients will receive an intra-articular injection 40 mg Depo-medrol mixed with 2 mL 0.25% bupivicaine in the sacroiliac joint.', 'interventionNames': ['Procedure: Sacroiliac intra-articular injection']}], 'interventions': [{'name': 'Sacroiliac intra-articular injection', 'type': 'PROCEDURE', 'description': 'CT guided injection of platelet-rich plasma versus steroid/anesthetic into the sacroiliac joint', 'armGroupLabels': ['Platelet-rich Plasma', 'Steroid/Anesthetic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ghazaleh Safazadeh', 'role': 'CONTACT', 'email': 'Ghazaleh.Safazadeh@hsc.utah.edu'}, {'name': 'Suyi Niu', 'role': 'CONTACT', 'email': 'Suyi.Niu@hsc.utah.edu', 'phone': '801-585-1021'}, {'name': 'Miriam Peckham, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zachary McCormick, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lubdha Shah, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Troy Hutchins, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yoshimi Anzai, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84148', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ghazaleh Safazadeh', 'role': 'CONTACT', 'email': 'Ghazaleh.Safazadeh@hsc.utah.edu'}, {'name': 'Suyi Niu', 'role': 'CONTACT', 'email': 'Suyi.Niu@hsc.utah.edu', 'phone': '801-585-1021'}, {'name': 'Miriam Peckham, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lubdha Shah, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Troy Hutchins, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yoshimi Anzai, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Veterans Administration Salt Lake City Health Care System', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Ghazaleh Safazadeh', 'role': 'CONTACT', 'email': 'Ghazaleh.Safazadeh@hsc.utah.edu', 'phone': '801-585-1021'}, {'name': 'Suyi Niu', 'role': 'CONTACT', 'email': 'Suyi.Niu@hsc.utah.edu', 'phone': '801-585-1021'}], 'overallOfficials': [{'name': 'Miriam Peckham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'collaborators': [{'name': 'Radiological Society of North America', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Miriam Peckham', 'investigatorAffiliation': 'University of Utah'}}}}