protocolSection identificationModule nctId: NCT06283628, orgStudyIdInfo id: STUDY00023737, briefTitle: Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves, acronym: LMB-RFA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Milton S. Hershey Medical Center, class: OTHER, descriptionModule briefSummary: The purpose of this voluntary research study is to determine whether the parasagittal approach to lumbar medial branch (LMB) nerve radio frequency ablation (RFA) will have greater efficacy than the traditional approach to lumbar medial branch nerve radio frequency ablation., conditionsModule conditions: Lumbar Spondylosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The subjects with bilateral low back pain will undergo radiofrequency ablation of the lumbar medial branch nerves using one approach (traditional) on one side and different approach (parasagittal) on the other side. One arm will use the traditional approach on the left and the parasagittal approach on the right. The other arm will use parasagittal approach on the left and the traditional approach on the right,, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: We will do computer randomization for the sides for each approach for all the subjects. The subjects will be assigned numbers, and the particular procedural approach for each side will be concealed in the numbered envelopes. The numbers on the envelopes will correspond to the numbers assigned to the patients. The envelopes will be opened by a treating physician in the procedure room. The patient and the assessor (who will not be the treating physician) will not know which procedural approach was used for the sides., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Radiofrequency ablation of lumbar medial branch nerves., outcomesModule primaryOutcomes measure: The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores)., primaryOutcomes measure: The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores)., primaryOutcomes measure: The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores)., secondaryOutcomes measure: Oswestry Disability index (ODI), secondaryOutcomes measure: Oswestry Disability index (ODI), secondaryOutcomes measure: Oswestry Disability index (ODI), otherOutcomes measure: Number of subjects who ceased requiring analgesia, otherOutcomes measure: Number of subjects who ceased requiring analgesia, otherOutcomes measure: Number of subjects who ceased requiring analgesia, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Penn State Hershey College of Medicine, city: Hershey, state: Pennsylvania, zip: 17033, country: United States, contacts name: Nancy Ruth Jarbadan, BS, role: CONTACT, phone: 717-531-6135, email: njarbadan@pennstatehealth.psu.edu, geoPoint lat: 40.28592, lon: -76.65025, hasResults: False