[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07193212":3,"trial-entities:NCT07193212":154,"trial-summary:NCT07193212":158},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":37,"secondary_outcomes":45,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":15,"eligibility_criteria":62,"std_ages":81,"locations":84,"central_contacts":100,"overall_officials":102,"references":106,"see_also_links":153},"NCT07193212","2024-206","How Osteopathic Treatment Affects the Leg and Foot in People With Low Back Pain","Osteopathic Manipulation Treatment Effect on the Leg and Foot Myofascial System in Adults With Chronic Low Back Pain - Pilot Study","RECRUITING","2026-12","2025-11","2026-05-14","2025-11-05","Edward Via Virginia College of Osteopathic Medicine","OTHER",false,"This pilot study will examine whether osteopathic manipulative treatment (OMT) can improve both physical and psychological aspects of chronic low back pain by focusing on the interconnected myofascial system of the back, legs, and feet. Twenty adults with chronic low back pain will receive four OMT sessions over 5-7 weeks. Before and after treatment, the investigators will measure muscle stiffness with ultrasound, plantar pressure during walking with a pressure plate, and patient-reported outcomes on pain, disability, sleep quality, stress, anxiety, depression, pain catastrophizing, and pain self-efficacy using surveys. By linking these objective and subjective measures, the study aims to provide early evidence of how OMT may influence musculoskeletal function, daily activity, and overall well-being, helping to guide future larger studies on treatment strategies for low back pain",null,[19],"Chronic Low Back Pain (CLBP)",[21,22,23],"chronic low back pain","myofascial systems","omt","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},20,"ESTIMATED",[32],{"type":14,"name":33,"description":34,"armGroupLabels":35},"Osteopathic Manipulative Treatment","Osteopathic Manipulative Treatment (OMT) is a hands-on approach where a trained physician uses techniques such as gentle pressure, stretching, and guided movements to improve mobility, reduce pain, and support the body's natural healing. It focuses on the interconnectedness of muscles, joints, and fascia to restore balance and function.",[36],"OMT Treatment Group",[38,42],{"measure":39,"description":40,"timeFrame":41},"Stiffness of Low Back and Lower Extremity Muscles Assessed by Ultrasound Shear Wave Elastography","Stiffness in the muscles of the low back and lower extremity will be quantitatively assessed using ultrasound shear wave elastography (SWE). SWE provides a non-invasive, reliable measure of tissue stiffness by calculating the shear wave speed (in meters\u002Fsecond) and corresponding elasticity modulus (in kilopascals). Regions of interest will be placed within target muscles and tissues (e.g., lumbar multifidus, thoracolumbar aponeurosis, hamstrings, gastrocnemius) and standardized acquisition protocols will be used to ensure reproducibility. This method allows for objective measurement of muscle stiffness rather than relying on subjective evaluation, thereby enhancing the validity of the outcome measure.","From baseline measures on Day 1 until the last OMT treatment, up to 6 weeks.",{"measure":43,"description":44,"timeFrame":41},"Body sway normalized path length, area, and velocity.","A triaxial accelerometer will be used to measure postural control. The sensor will be secured over the lower trunk and measurements will occur under six conditions: feet together eyes open, feet together eyes closed, single-leg stance on the right and left with eyes opened and eyes closed. An average of 3 trials per condition will be used for each stance with 1 minute rest between trials. Double leg stance trials will be performed for 30 seconds while single leg stance trials will be performed for 15 seconds. Normalized path length (NPL) of acceleration in the anteroposterior (AP) and mediolateral (ML) directions, and sway excursion area, and velocity will be determined.",[46,50,53,56],{"measure":47,"description":48,"timeFrame":49},"Low back pain intensity and frequency.","Low back and lower extremity pain intensity, and frequency measured by an NRS (intensity) and Likert scale (frequency).","From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.",{"measure":51,"description":52,"timeFrame":49},"Functional disability.","The Roland-Morris Disability Questionnaire will be used to score functional disability.",{"measure":54,"description":55,"timeFrame":41},"Plantar Pressure Changes Assessed by EMED Pedobarographic Platform","Plantar pressure distribution will be assessed using a validated EMED pedobarographic platform (Novel), which records dynamic foot pressures during gait. Outcome parameters will include peak pressure (kPa), pressure-time integrals, and center of pressure trajectory. Participants will walk barefoot at a self-selected pace across the platform, and standardized protocols will be used to ensure reproducibility. An average of 5 measures from each foot will be obtained.",{"measure":57,"description":58,"timeFrame":49},"Pain self-efficacy score","The pain self-efficacy questionnaire will be used to assess participants confidence in their ability to perform various activities and achieve goals despite experiencing pain, and its relationship to clinical response to treatment.","ALL","18 Years","65 Years",{"inclusion":63,"exclusion":66,"raw_text":80},[64,65],"male and female subjects 18-65 years old","presence of chronic low back \\> 3 months duration or pain present \\> 50% of the time within the previous 12 months",[67,68,69,70,71,72,73,74,75,76,77,78,79],"prior surgery of the thoracic, lumbar or sacral spine, pelvis","diagnosis lumbar radiculopathy or pinched nerve in the neck","diagnosis of foot condition that alters gait","diagnosis of connective tissue or muscle disorders","diagnosis of cancer","previous spinal cord injury inflammatory arthritis and fibromyalgia","pregnancy","tobacco use","known diabetes or prediabetes","allergy to ultrasound gel (propylene glycol)","history of manual therapy treatment within the past 2 weeks","injection for pain within the past 1 month","currently taking muscle relaxers","Inclusion Criteria:\n\n* male and female subjects 18-65 years old\n* presence of chronic low back \\> 3 months duration or pain present \\> 50% of the time within the previous 12 months\n\nExclusion Criteria:\n\n* prior surgery of the thoracic, lumbar or sacral spine, pelvis\n* diagnosis lumbar radiculopathy or pinched nerve in the neck\n* diagnosis of foot condition that alters gait\n* diagnosis of connective tissue or muscle disorders\n* diagnosis of cancer\n* previous spinal cord injury inflammatory arthritis and fibromyalgia\n* pregnancy\n* tobacco use\n* known diabetes or prediabetes\n* allergy to ultrasound gel (propylene glycol)\n* history of manual therapy treatment within the past 2 weeks\n* injection for pain within the past 1 month\n* currently taking muscle relaxers",[82,83],"ADULT","OLDER_ADULT",[85],{"facility":86,"status":8,"city":87,"state":88,"zip":89,"country":90,"contacts":91,"geoPoint":97},"Edward Via College of Osteopathic Medicine","Auburn","Alabama","36832","United States",[92],{"name":93,"role":94,"phone":95,"email":96},"Daniel Cawley, DC, MS, MSHS","CONTACT","334-442-4105","dcawley@vcom.edu",{"lat":98,"lon":99},32.60986,-85.48078,[101],{"name":93,"role":94,"phone":95,"email":96},[103],{"name":93,"affiliation":104,"role":105},"VCOM","PRINCIPAL_INVESTIGATOR",[107,111,114,117,120,123,126,129,132,135,138,141,144,147,150],{"pmid":108,"type":109,"citation":110},"29382241","BACKGROUND","Berenshteyn Y, Gibson K, Hackett GC, Trem AB, Wilhelm M. Is standing balance altered in individuals with chronic low back pain? A systematic review. Disabil Rehabil. 2019 Jun;41(13):1514-1523. doi: 10.1080\u002F09638288.2018.1433240. Epub 2018 Jan 30.",{"pmid":112,"type":109,"citation":113},"34823100","Wang H, Zheng J, Fan Z, Luo Z, Wu Y, Cheng X, Yang J, Zhang S, Yu Q, Lo WLA, Wang C. Impaired static postural control correlates to the contraction ability of trunk muscle in young adults with chronic non-specific low back pain: A cross-sectional study. Gait Posture. 2022 Feb;92:44-50. doi: 10.1016\u002Fj.gaitpost.2021.11.021. Epub 2021 Nov 19.",{"pmid":115,"type":109,"citation":116},"37193730","Park J, Nguyen VQ, Ho RLM, Coombes SA. The effect of chronic low back pain on postural control during quiet standing: A meta-analysis. Sci Rep. 2023 May 16;13(1):7928. doi: 10.1038\u002Fs41598-023-34692-w.",{"pmid":118,"type":109,"citation":119},"21762484","Ruhe A, Fejer R, Walker B. Is there a relationship between pain intensity and postural sway in patients with non-specific low back pain? BMC Musculoskelet Disord. 2011 Jul 15;12:162. doi: 10.1186\u002F1471-2474-12-162.",{"pmid":121,"type":109,"citation":122},"37719924","Ryum T, Stiles TC. Changes in pain catastrophizing, fear-avoidance beliefs, and pain self-efficacy mediate changes in pain intensity on disability in the treatment of chronic low back pain. Pain Rep. 2023 Sep 13;8(5):e1092. doi: 10.1097\u002FPR9.0000000000001092. eCollection 2023 Sep.",{"pmid":124,"type":109,"citation":125},"30930571","Ogunlana MO, Odole AC, Adejumo A, Odunaiya N. Catastrophising, pain, and disability in patients with nonspecific low back pain. Hong Kong Physiother J. 2015 Dec;33(2):73-79. doi: 10.1016\u002Fj.hkpj.2015.03.001. Epub 2015 Apr 16.",{"pmid":127,"type":109,"citation":128},"35619991","Xu C, Fu Z, Wang J, Wu B, Wang XQ. Differences and Correlations of Anxiety, Sleep Quality, and Pressure-Pain Threshold between Patients with Chronic Low Back Pain and Asymptomatic People. Pain Res Manag. 2022 May 17;2022:8648584. doi: 10.1155\u002F2022\u002F8648584. eCollection 2022.",{"pmid":130,"type":109,"citation":131},"33720272","Nguyen C, Boutron I, Zegarra-Parodi R, Baron G, Alami S, Sanchez K, Daste C, Boisson M, Fabre L, Krief P, Krief G, Lefevre-Colau MM, Rannou F. Effect of Osteopathic Manipulative Treatment vs Sham Treatment on Activity Limitations in Patients With Nonspecific Subacute and Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Intern Med. 2021 May 1;181(5):620-630. doi: 10.1001\u002Fjamainternmed.2021.0005.",{"pmid":133,"type":109,"citation":134},"31077992","Murillo C, Falla D, Rushton A, Sanderson A, Heneghan NR. Shear wave elastography investigation of multifidus stiffness in individuals with low back pain. J Electromyogr Kinesiol. 2019 Aug;47:19-24. doi: 10.1016\u002Fj.jelekin.2019.05.004. Epub 2019 May 3.",{"pmid":136,"type":109,"citation":137},"24049103","Menz HB, Dufour AB, Riskowski JL, Hillstrom HJ, Hannan MT. Foot posture, foot function and low back pain: the Framingham Foot Study. Rheumatology (Oxford). 2013 Dec;52(12):2275-82. doi: 10.1093\u002Frheumatology\u002Fket298. Epub 2013 Sep 17.",{"pmid":139,"type":109,"citation":140},"29202429","McClinton S, Weber CF, Heiderscheit B. Low back pain and disability in individuals with plantar heel pain. Foot (Edinb). 2018 Mar;34:18-22. doi: 10.1016\u002Fj.foot.2017.09.003. Epub 2017 Sep 28.",{"pmid":142,"type":109,"citation":143},"36561877","Loffler M, Schneider P, Schuh-Hofer S, Kamping S, Usai K, Treede RD, Nees F, Flor H. Stress-induced hyperalgesia instead of analgesia in patients with chronic musculoskeletal pain. Neurobiol Pain. 2022 Dec 6;13:100110. doi: 10.1016\u002Fj.ynpai.2022.100110. eCollection 2023 Jan-Jul.",{"pmid":145,"type":109,"citation":146},"26927908","Licciardone JC, Gatchel RJ, Aryal S. Recovery From Chronic Low Back Pain After Osteopathic Manipulative Treatment: A Randomized Controlled Trial. J Am Osteopath Assoc. 2016 Mar;116(3):144-55. doi: 10.7556\u002Fjaoa.2016.031.",{"pmid":148,"type":109,"citation":149},"26591401","Anukoolkarn K, Vongsirinavarat M, Bovonsunthonchai S, Vachalathiti R. Plantar Pressure Distribution Pattern during Mid-Stance Phase of the Gait in Patients with Chronic Non-Specific Low Back Pain. J Med Assoc Thai. 2015 Sep;98(9):896-901.",{"pmid":151,"type":109,"citation":152},"21190045","Alsaadi SM, McAuley JH, Hush JM, Maher CG. Prevalence of sleep disturbance in patients with low back pain. Eur Spine J. 2011 May;20(5):737-43. doi: 10.1007\u002Fs00586-010-1661-x. Epub 2010 Dec 29.",[],{"nct_id":4,"conditions":155,"biomarkers":157},[156],"Chronic low back pain",[],{"nct_id":4,"found":159,"summary":160,"prompt_version":170},true,{"design":161,"status":162,"heading":163,"summary":164,"follow_up":165,"word_count":166,"commitments":167,"compensation":168,"drugs_mentioned":169},"This is a pilot study that will involve 20 participants. It is an interventional study, meaning participants will receive a specific treatment.","completed","Osteopathic Treatment for Chronic Low Back Pain","This study is looking at how Osteopathic Manipulative Treatment (OMT) might help people with chronic low back pain. OMT is a hands-on approach where a trained physician uses gentle pressure and movements to improve mobility and reduce pain. Researchers want to see if OMT can improve both physical symptoms, like muscle stiffness in your back, legs, and feet, and how you feel emotionally, such as your stress or anxiety levels. They are looking for 20 adults, aged 18 to 65, who have had low back pain for at least three months. Success will be measured by changes in muscle stiffness (using ultrasound) and how your body sways, along with your reports on pain, disability, and mood over about 6 weeks. The study status is currently unclear.","Measurements will be taken from the start of the study until the last OMT treatment, which is up to 6 weeks.",126,"You would receive four Osteopathic Manipulative Treatment (OMT) sessions over 5-7 weeks. Before and after treatment, researchers will measure muscle stiffness with ultrasound, plantar pressure during walking, and you will complete surveys about your pain and well-being.","Not stated in the trial record.",[33],"v2"]