protocolSection identificationModule nctId: NCT06294132, orgStudyIdInfo id: 4016601, briefTitle: Effect of Lumbar Manipulation on Intervertebral Motion, Pain, and Disability, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2024-10-21, completionDateStruct date: 2024-10-28, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Ithaca College, class: OTHER, descriptionModule briefSummary: Background / Purpose:There is an ongoing debate regarding the ability of physical therapists to manually sense intervertebral motion. Physical therapists use intervertebral hypomobility as a clinical indicator for spinal manipulation. Also in question is the mechanism of improvement observed after spinal manipulation. Some argue that the improvement is purely neurophysiologic and unrelated to changes in intervertebral motion. This study aimed to determine the diagnostic accuracy of a physical therapist's manual assessment of lumbar intervertebral motion compared to ultrasound imaging and the effect of lumbar manipulation on intervertebral motion, pain, and disability,Methods:Subjects will complete a Numeric Pain Rating Scale (NPR),Oswestry Disability Index (ODI), and a Central Sensitization Inventory before arriving for the study via Qualtrics survey tool. They will be screened for contraindications to manipulation and neurological signs and symptoms. Active forward bending will be quantified by measuring the distance of the subject's fingertips to the floor. Two experienced physical therapists will evaluate the subject's lumbar intervertebral mobility. They will identify the lumbar segment with the least motion or hypomobility. The subjects will be imaged from L1 to S1 with a 5 MHz curvilinear transducer (Edge II MSK ultrasound unit, SonoSite, Inc, Bothell, WA) in the sidlying position with their trunk and hips flexed to end-range. The examiner will save the sagittal image and then place a digital caliper to measure the distance between the spinous processes from the peak of the hyperechoic curvature of the caudal spinous process to the peak of the hyperechoic curvature of the cranial spinous process of each lumbar segment (L5-S1, L4-L5, L3-L2,L2-L1). Subjects will then be randomized to receive a high-velocity low amplitude thrust manipulation or a sham manipulation. The lumbar spine will be reimaged. The ultrasound examiner will be blinded to the manipulation and the caliper measurements. Finally, subjects will be asked for their Global Rating of Change (GROC) and to actively bend forward to remeasure the distance of their fingertips to the floor. One week later, patients will receive an e-mail containing links to repeat the NPR, GROC, and ODI., conditionsModule conditions: Low Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomly assigned to either receive lumbar manipulation or a sham lumbar manipulation., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Participant: the participants will not know whether they received the lumbar manipulation or sham lumbar manipulation.Care Provider: the care providers (those who perform the lumbar manipulation and sham lumbar manipulation) will not be involved in collecting any outcome data.Investigator: all investigators collecting outcome measures will not know which subjects received the lumbar manipulation or sham lumbar manipulation.Outcome assessor: the outcome assessors will not be involved in collecting data., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Lumbar Manipulation, interventions name: Sham Lumbar Manipulation, outcomesModule primaryOutcomes measure: Diagnostic Ultrasound, secondaryOutcomes measure: Trunk Flexion Range Of Motion Measurement, secondaryOutcomes measure: Oswestry Disability Questionnaire, secondaryOutcomes measure: Numeric Pain Rating Scale, secondaryOutcomes measure: Global Rating of Change, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ithaca College, status: RECRUITING, city: Ithaca, state: New York, zip: 14850, country: United States, contacts name: John Winslow, role: CONTACT, phone: 607-229-8792, email: jwinslow@ithaca.edu, contacts name: Michael Costello, role: CONTACT, email: mcostello@ithaca.edu, geoPoint lat: 42.44063, lon: -76.49661, hasResults: False