[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614917":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":47,"studyPopulation":40,"armGroups":48,"interventions":55,"overallOfficials":40,"centralContacts":40,"locations":40,"responsibleParty":61,"collaborators":63,"id":68,"slug":40,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":40,"eligibilityCriteria":72,"healthyVolunteers":69,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":40,"studyType":79,"phases":80,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":99,"whyStopped":40,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":40},{"fullName":5,"class":6},"Evidence In Motion","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":40},[9,13],{"measure":10,"description":11,"timeFrame":12},"Low Back Pain Intensity (NPRS - Low Back)","Change in self-reported low back pain intensity measured using the 0-10 Numeric Pain Rating Scale (NPRS), where 0 = no pain and 10 = worst imaginable pain.","Pre-intervention to immediately post-intervention (same session).",{"measure":14,"description":15,"timeFrame":12},"Leg Pain Intensity (NPRS - Leg)","Change in self-reported leg pain intensity using the 0-10 NPRS.",[17,21,24,27,30,33,36],{"measure":18,"description":19,"timeFrame":20},"Oswestry Disability Index (ODI)","Change in disability level measured by the 10-item ODI questionnaire. Scores range from 0-50, multiplied by 2 to produce a percentage (0-100%), with higher scores indicating greater disability.","Pre-intervention to immediately post-intervention.",{"measure":22,"description":23,"timeFrame":20},"Fear-Avoidance Beliefs Questionnaire (FABQ) - Physical Activity Subscale","Change in fear-avoidance beliefs related to work. The 7-item FABQ-W yields scores from 0-42, with higher scores indicating greater work-related fear-avoidance.",{"measure":25,"description":26,"timeFrame":20},"Pain Catastrophization Scale (PCS)","Change in pain catastrophizing as measured by the 13-item PCS. Total scores range from 0-52, with higher scores indicating greater catastrophic thinking about pain.",{"measure":28,"description":29,"timeFrame":20},"Active Lumbar Flexion (Fingertip-to-Floor Distance)","Change in active trunk forward flexion measured in centimeters from the tip of the longest finger of the dominant hand to the floor. Lower values indicate greater lumbar and hamstring mobility.",{"measure":31,"description":32,"timeFrame":20},"Straight Leg Raise (SLR)","Change in SLR measured using an inclinometer placed on the tibia. SLR is measured on the most affected leg, with the ankle maintained in neutral. Degrees of hip flexion are recorded.",{"measure":34,"description":35,"timeFrame":20},"Pain Distribution (Body Chart Grid Count)","Change in pain distribution measured using a standardized body chart. Pain areas are quantified using a grid overlay, producing a count of regions marked by the participant.",{"measure":37,"description":38,"timeFrame":39},"Symptom Centralization (Qualitative Report)","Presence or absence of centralization of symptoms based on patient self-report during or after the motor imagery extension protocol. Centralization is defined as a proximal shift of pain toward the lumbar spine.","Immediately post-intervention.",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":40,"primaryPurpose":44,"observationalModel":40,"timePerspective":40,"maskingInfo":45},"NA","SINGLE_GROUP","TREATMENT",{"masking":46,"maskingDescription":40,"whoMasked":40},"NONE","Background and Rationale:\n\nLow back pain (LBP) is the most common musculoskeletal condition treated in outpatient physical therapy, accounting for approximately 25-40% of patient visits. Directional preference, a key element of the McKenzie method, is widely used in the management of LBP. This approach assesses how a patient's symptoms respond to repeated or sustained directional movements-most commonly flexion or extension-and integrates the direction that reduces or centralizes symptoms into the treatment plan. Previous research demonstrates that extension-based directional preference strategies are effective for a large proportion of patients with LBP and are associated with pain reduction, increased mobility, reduced fear of movement, and centralization of radiating symptoms.\n\nIn parallel with traditional mechanical assessment and treatment methods, pain neuroscience research has highlighted the role of changes in cortical body maps, particularly in the primary somatosensory cortex (S1), in individuals with LBP. People with persistent LBP exhibit altered S1 representations, including changes in size and organization of cortical maps, which are associated with pain, disability, and functional limitations. These representations are dynamic, and movement-based therapies can help normalize them.\n\nHowever, patients with high pain levels, significant fear-avoidance, or sensitized nervous systems may find movement-based interventions difficult to perform. Motor imagery-mentally simulating movement without performing it physically-may provide an alternative method for modifying cortical representations while reducing threat and avoiding symptom aggravation. Motor imagery activates neural regions similar to those used during actual movement execution and may be beneficial for individuals reluctant to engage in active movement.\n\nPreliminary findings have suggested that virtual or imagery-based McKenzie extension movements may improve pain, fear-avoidance, catastrophization, and mobility in individuals with LBP. Because centralization of symptoms is a hallmark feature of directional preference-based care, this study aims to further explore whether a brief motor imagery-based extension protocol can influence pain intensity, body pain distribution, psychological constructs, physical measures, and centralization in patients with LBP who demonstrate an extension directional preference.\n\nStudy Objectives:\n\nThe primary objective of this study is to evaluate the immediate effects of a guided motor imagery extension protocol in patients with LBP who demonstrate a directional preference for extension. The study aims to determine whether the intervention results in changes in pain intensity, disability, fear-avoidance, pain catastrophization, lumbar flexion, straight leg raise, and pain distribution, as well as whether patients report centralization of symptoms.\n\nStudy Design:\n\nThis study is a single-group, pre-post exploratory design conducted across three outpatient physical therapy clinics. Institutional Review Board approval will be obtained prior to study initiation. Eligible patients presenting with LBP will be identified during their initial evaluation. Participants must be between 18 and 65 years of age, able to read and understand English, present with no red flags during review of systems, have no prior spinal surgery, and demonstrate a positive response to extension-based directional preference testing. Participation is voluntary and requires written informed consent.\n\nIntervention Procedures:\n\nFollowing consent, participants will complete a demographics questionnaire. A blinded therapist will administer baseline measures including disability, pain intensity, fear-avoidance beliefs, pain catastrophization, active trunk flexion, straight leg raise (SLR), and a pain body chart.\n\nParticipants will then receive a brief educational explanation of cortical map changes associated with LBP. Next, participants will assume a prone \"pre-press-up\" position, placing their hands under their shoulders. Instead of performing an active press-up, they will close their eyes and receive verbal guidance through a series of ten motor imagery-based lumbar extension movements. The standardized script instructs participants to visualize completing a full press-up, experiencing spinal extension, holding briefly at end range, and returning to the starting position. Total intervention time is approximately five minutes.\n\nImmediately following the imagery protocol, a blinded therapist will repeat all outcome measures. After data collection, clinicians will resume their usual plan of care for each patient.\n\nOutcome Measures:\n\nPre- and post-intervention measures include:\n\nOswestry Disability Index (ODI) to assess functional disability\n\nNumeric Pain Rating Scale (NPRS) for low back and leg pain\n\nFear Avoidance Beliefs Questionnaire (FABQ), including Physical Activity and Work subscales\n\nPain Catastrophization Scale (PCS)\n\nActive lumbar flexion (fingertip-to-floor distance in centimeters)\n\nStraight Leg Raise measured with an inclinometer\n\nBody chart with grid overlay to quantify pain distribution and potential changes in cortical representation\n\nData Management and Analysis:\n\nDe-identified data will be compiled and analyzed using descriptive statistics for demographic variables. Pre- and post-intervention comparisons will be performed using paired-samples t-tests with significance set at p \\\u003C 0.05. Significant findings will be confirmed with Wilcoxon Signed Ranks nonparametric testing.",[49],{"label":50,"type":51,"description":52,"interventionNames":53},"Motor Imagery Extension Protocol","EXPERIMENTAL","Participants with low back pain who demonstrate a directional preference for extension will receive a single session of a guided motor imagery protocol simulating lumbar extension movements based on the McKenzie method. The intervention is designed to mentally replicate an extension press-up without requiring physical movement.",[54],"Behavioral: Motor Imagery-Based Lumbar Extension",[56],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":40},"BEHAVIORAL","Motor Imagery-Based Lumbar Extension","Participants will lie prone with hands positioned under the shoulders in a standard \"pre-press-up\" position. With eyes closed, participants will be verbally guided through ten imagined lumbar extension press-ups. The standardized motor imagery script includes:\n\nFocusing attention on current back and leg symptoms\n\nImagining pushing the arms into extension\n\nVisualizing the back arching into extension\n\nHolding the imagined end-range position for several seconds\n\nImagining returning to the starting position in a controlled manner\n\nRepeating this process ten times\n\nTotal duration of the protocol is approximately 5 minutes.\n\nMode of Delivery:\n\nIn-person, guided by a physical therapist trained in the study protocol.\n\nPurpose:\n\nTo evaluate immediate changes in pain, disability, psychological measures, physical mobility, neurodynamic measures, and symptom centralization following a motor imagery-based extension intervention.",[50],{"type":62,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[64,66],{"name":65,"class":6},"University of Nevada, Las Vegas",{"name":67,"class":6},"College of St. Scholastica, Inc.","100614917",false,"NCT07285824","Virtual McKenzie Exercises and Centralization of Pain: A Pilot Study","Inclusion Criteria:\n\nAge 18 to 65 years\n\nPresenting to outpatient physical therapy with low back pain (LBP)\n\nAble to read and understand English\n\nNo red flags identified during review of systems and initial physical therapy evaluation\n\nNo prior spinal surgery\n\nDemonstrates a positive response to extension-based directional preference testing\n\nWilling and able to provide written informed consent\n\nExclusion Criteria:\n\nAge younger than 18 or older than 65\n\nInability to read or understand English\n\nPresence of red flags during review of systems (e.g., suspected fracture, malignancy, infection, cauda equina symptoms)\n\nHistory of spinal surgery\n\nNo demonstrable directional preference for extension during evaluation\n\nAny condition that the evaluating clinician determines would preclude safe participation\n\nDeclines to participate or is unable to provide informed consent","ALL","18 Years","65 Years",{"count":77,"type":78},40,"ESTIMATED","INTERVENTIONAL",[42],"Low back pain (LBP) is frequently managed in physical therapy using the McKenzie method, in which a patient's directional preference-most commonly extension-is used to guide treatment. Extension-based interventions are associated with symptom improvement and centralization in many individuals with LBP. At the same time, research in pain neuroscience has shown that people with LBP may have altered cortical representations of the low back, which may contribute to pain and disability. For patients who experience high pain levels or significant fear of movement, active directional preference exercises may be difficult to perform.\n\nMotor imagery, the mental simulation of movement without physical execution, has been shown to activate brain regions involved in movement and may help modify altered cortical representations. Preliminary research has suggested that virtual or imagery-based McKenzie extension exercises may improve pain and movement-related outcomes.\n\nThis exploratory study aims to evaluate the immediate effects of a brief motor imagery-based extension protocol in adults with LBP who demonstrate a directional preference for extension. The study will assess changes in pain intensity, disability, fear-avoidance, pain catastrophization, lumbar flexion, straight leg raise, pain distribution, and symptom centralization following a single motor imagery session.",[83,84],"Chronic Pain","Low Back Pain",[84,83,86,87,88,89,90,91,92,93,94,95,96,97,98],"Directional Preference","McKenzie Method","Extension-Based Exercise","Motor Imagery","Virtual Exercise","Pain Centralization","Fear-Avoidance","Pain Catastrophization","Physical Therapy","Cortical Representation","Somatosensory Cortex (S1)","Body Schema","Disability","NOT_YET_RECRUITING","2025-12-03",{"date":102,"type":103},"2025-12-16","ACTUAL",{"date":105,"type":78},"2025-12",{"date":107,"type":78},"2026-11",{"name":5,"class":6}]