Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers
Launched by THE CLEVELAND CLINIC · Jan 17, 2024

Apply for Trial

Nctid: NCT06225583

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D013577", "term"=>"Syndrome"}, {"id"=>"D017116", "term"=>"Low Back Pain"}], "ancestors"=>[{"id"=>"D004194", "term"=>"Disease"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D001416", "term"=>"Back Pain"}, {"id"=>"D010146", "term"=>"Pain"}, {"id"=>"D009461", "term"=>"Neurologic Manifestations"}], "browseLeaves"=>[{"id"=>"M4714", "name"=>"Back Pain", "relevance"=>"LOW"}, {"id"=>"M19433", "name"=>"Low Back Pain", "asFound"=>"Lower Back Pain", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "asFound"=>"Syndrome", "relevance"=>"HIGH"}, {"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"CASE_CONTROL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>40}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-01-17", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-02", "completionDateStruct"=>{"date"=>"2026-12", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-02-08", "studyFirstSubmitDate"=>"2024-01-17", "studyFirstSubmitQcDate"=>"2024-01-17", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-09", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-12", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"To identify Bertolotti's Syndrome-specific kinematic biomarkers using collected patient kinematic and real-time VAS data from range-of-motion tasks.", "timeFrame"=>"2025"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Bertolotti's Syndrome", "Lower Back Pain"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to collect lumbar rotations, velocity, and accelerations, along with pain scores using a novel dynamic VAS device, from twenty (20) Bertolotti Syndrome patients and twenty (20) non-Bertolotti low back pain patients during range-of-motion tasks. The assessments will be analyzed to determine the differences in kinematics and continuous pain scores between Bertolotti patients and non-Bertolotti low back pain patients."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"20 Bertolotti's Syndrome patients and 20 lower back pain patients", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\nLower Back Pain Cohort\n\n* Positive diagnosis of sacroiliac pain or lumbosacral facet arthritis pain\n* Age ≥ 18 years\n\nBertolotti's Syndrome Cohort\n\n* Positive diagnosis of Bertolotti's Syndrome\n* Age ≥ 18 years\n* Positive imaging for Bertolotti's Syndrome\n* Previous analgesic injection results\n\nExclusion Criteria:\n\nLower Back Pain Cohort\n\n* History of spinal deformity, previous spinal surgeries, spinal infections\n* Pregnant women\n\nBertolotti's Syndrome Cohort\n\n* History of spinal deformity, previous spinal surgeries, spinal infections\n* Pregnant women"}, "identificationModule"=>{"nctId"=>"NCT06225583", "briefTitle"=>"Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers", "organization"=>{"class"=>"OTHER", "fullName"=>"The Cleveland Clinic"}, "officialTitle"=>"Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers", "orgStudyIdInfo"=>{"id"=>"IRB 22-1310"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Bertolotti's Syndrome", "description"=>"Subjects with Bertolotti's Syndrome."}, {"label"=>"Non-Bertolotti's Lower Back Pain", "description"=>"Subjects without Bertolotti's Syndrome with lower back pain."}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"44195", "city"=>"Cleveland", "state"=>"Ohio", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Michael Steinmetz", "role"=>"CONTACT", "email"=>"steinmm@ccf.org"}], "facility"=>"Cleveland Clinic", "geoPoint"=>{"lat"=>41.4995, "lon"=>-81.69541}}], "centralContacts"=>[{"name"=>"nya robinson", "role"=>"CONTACT", "email"=>"robinsn8@ccf.org", "phone"=>"216-445-1741"}, {"name"=>"Claudia Tellman", "role"=>"CONTACT", "email"=>"tellmac@ccf.org", "phone"=>"216-444-3026"}], "overallOfficials"=>[{"name"=>"Michael Steinmetz, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"The Cleveland Clinic"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"The Cleveland Clinic", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Chairman, Department of Neurosurgery", "investigatorFullName"=>"Michael Steinmetz, MD", "investigatorAffiliation"=>"The Cleveland Clinic"}}}}

Edit this trial

Back to trials

Trial Information

Current as of December 21, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying Bertolotti's Syndrome, a condition that causes lower back pain, by looking for specific movement patterns and pain levels in patients. Researchers want to understand how the movements and pain scores of patients with Bertolotti's Syndrome compare to those with other types of lower back pain. To do this, they will collect data from twenty patients diagnosed with Bertolotti's Syndrome and twenty patients with different lower back pain issues while they perform certain movements.

To be eligible for this study, participants must be at least 18 years old and have a confirmed diagnosis of either Bertolotti's Syndrome or another type of lower back pain. They should not have a history of spinal deformities, previous spinal surgeries, or infections, and pregnant women cannot participate. Participants can expect to undergo movement tests that will help researchers gather important information about their pain and mobility. This study is currently recruiting participants, and your involvement could help improve understanding and treatment options for people suffering from lower back pain.

Gender

ALL

Eligibility criteria

Inclusion Criteria:
• Lower Back Pain Cohort
• Positive diagnosis of sacroiliac pain or lumbosacral facet arthritis pain
• Age ≥ 18 years
• Bertolotti's Syndrome Cohort
• Positive diagnosis of Bertolotti's Syndrome
• Age ≥ 18 years
• Positive imaging for Bertolotti's Syndrome
• Previous analgesic injection results
Exclusion Criteria:
• Lower Back Pain Cohort
• History of spinal deformity, previous spinal surgeries, spinal infections
• Pregnant women
• Bertolotti's Syndrome Cohort
• History of spinal deformity, previous spinal surgeries, spinal infections
• Pregnant women

Trial Officials

Michael Steinmetz, MD

Principal Investigator

The Cleveland Clinic

About The Cleveland Clinic

The Cleveland Clinic is a renowned nonprofit academic medical center based in Cleveland, Ohio, recognized for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, the Cleveland Clinic leverages its multidisciplinary expertise and state-of-the-art facilities to conduct groundbreaking studies aimed at improving patient outcomes across a wide range of medical conditions. With a strong emphasis on patient-centered care, the institution fosters collaboration among researchers, clinicians, and patients to explore new treatments and therapies, contributing significantly to the global body of medical knowledge.

Locations

Cleveland, Ohio, United States

People applied

0 patients applied

Timeline

First submit

January 17, 2024

Trial launched

January 17, 2024

Trial updated

February 08, 2024

Estimated completion

Not reported

Discussion 0

Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers Launched by THE CLEVELAND CLINIC · Jan 17, 2024

Frequently Asked Questions About Clinical Trials

Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers
Launched by THE CLEVELAND CLINIC · Jan 17, 2024