[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07712458":3,"trial-entities:NCT07712458":104,"trial-summary:NCT07712458":108},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":40,"sex":47,"minimum_age":48,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":49,"std_ages":76,"locations":79,"central_contacts":89,"overall_officials":95,"references":99,"see_also_links":100},"NCT07712458","26-002257","Magnetic Resonance Elastography Of Chronic Low Back Pain Before And After Therapy","Magnetic Resonance Elastography Assessment Of Chronic Low Back Pain Before And After A Manual Therapy Intervention","NOT_YET_RECRUITING","2028-08-01","2026-07","2026-07-22","2026-08-01","Mayo Clinic","OTHER",false,"The purpose of this study is to quantify Magnetic Resonance Elastography (MRE)-derived mechanical property biomarkers of the lumbar paraspinal musculature and associated myofascial tissue regions before and after the intervention.",null,[19,20],"Low Back Pain, Recurrent","Chronic Low Back Pain (CLBP)",[],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},38,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","EMMA (Expert Manipulative Massage Automation)","Participants will receive device-assisted massage therapy using EMMA (Expert Manipulative Massage Automation). Each treatment session will last approximately 30 minutes. The device will be operated using conservative settings with predefined maximum force and pressure limits.",[35],"Expert Manipulative Massage Automation (EMMA)",[37],{"measure":38,"timeFrame":39},"Change in SII-derived mobility index","Baseline, 30 minutes post-intervention",[41,44],{"measure":42,"description":43,"timeFrame":39},"Change in Pain, Enjoyment of Life, and General Activity (PEG) Scale Score","The Pain, Enjoyment of Life, and General Activity (PEG) scale is a 3-item participant-reported measure used to assess pain intensity and pain-related interference with enjoyment of life and general activity. The total PEG score is calculated as the average of the 3 item scores and ranges from 0 to 10, with higher scores indicating greater pain severity and interference.",{"measure":45,"description":46,"timeFrame":39},"Change in Spinal Range of Motion (ROM)","Spinal range of motion will be assessed by a clinical assessor using a bubble inclinometer. Measurements will include lumbar flexion and right and left lateral bending. The outcome will be reported as the change from baseline in spinal range of motion, measured in degrees.","ALL","18 Years",{"inclusion":50,"exclusion":58,"raw_text":75},[51,52,53,54,55,56,57],"Adult males or females (age ≥ 18 years)","Report chronic low back pain (≥3 months) (measured by patient history and clinical evaluation)","Pain intensity reported at baseline must be ≥4 on the pain VAS scale","Presence of myofascial pain features in the lumbar region (e.g., localized tenderness and\u002For trigger points identified by a qualified clinician\u002Ftherapist)","Able to lie in supine and prone positions for study procedures","Be able to participate fully in all aspects of the study","Have understood and signed study informed consent",[59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74],"Pregnancy or breastfeeding","Patients with the inability to stay in a prone and supine position for the required procedure durations (e.g., ≥30 minutes at a time)","Any contraindication to an MRI exam, or severe claustrophobia that would prevent safe completion of the scan","Previous lumbar spine surgery or history of severe lumbar injury (e.g., fracture) that, in the investigation team's judgment, would interfere with participation or safety","Patients with known bleeding disorders or current therapeutic anticoagulation that would increase risk of bruising\u002Fbleeding with massage","Patients with skin conditions affecting the treatment area (e.g., rash, open wound, active dermatitis) or known allergy to any materials used during treatment (e.g., gels\u002Fcleaners), if applicable","Receipt of a new pain treatment within 3 days of the study visit (e.g., injection, ablation, spinal manipulation, massage\u002Fmanual therapy) that could confound pre\u002Fpost measures","Use of short-acting opioid analgesics or sedating medications within 24 hours of the study visit","Have an implanted device in or near the treatment area that could interfere with safe application of external pressure","Have used an investigational drug within 30 days of study enrollment","History of any major cardiovascular events including heart valve disease, ongoing angina, cardiac arrhythmias, congestive heart failure, acute coronary syndrome, stroke, transient ischemic attack, or peripheral vascular disease.","Clinically significant unstable neurologic or systemic illness that would preclude safe participation, as judged by the investigation team.","Surgical intervention for pain within 1 month prior to enrollment","Active infection, wound, or other external trauma to the areas to be treated","Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence","Inability to provide consent","Inclusion Criteria:\n\n* Adult males or females (age ≥ 18 years)\n* Report chronic low back pain (≥3 months) (measured by patient history and clinical evaluation)\n* Pain intensity reported at baseline must be ≥4 on the pain VAS scale\n* Presence of myofascial pain features in the lumbar region (e.g., localized tenderness and\u002For trigger points identified by a qualified clinician\u002Ftherapist)\n* Able to lie in supine and prone positions for study procedures\n* Be able to participate fully in all aspects of the study\n* Have understood and signed study informed consent\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Patients with the inability to stay in a prone and supine position for the required procedure durations (e.g., ≥30 minutes at a time)\n* Any contraindication to an MRI exam, or severe claustrophobia that would prevent safe completion of the scan\n* Previous lumbar spine surgery or history of severe lumbar injury (e.g., fracture) that, in the investigation team's judgment, would interfere with participation or safety\n* Patients with known bleeding disorders or current therapeutic anticoagulation that would increase risk of bruising\u002Fbleeding with massage\n* Patients with skin conditions affecting the treatment area (e.g., rash, open wound, active dermatitis) or known allergy to any materials used during treatment (e.g., gels\u002Fcleaners), if applicable\n* Receipt of a new pain treatment within 3 days of the study visit (e.g., injection, ablation, spinal manipulation, massage\u002Fmanual therapy) that could confound pre\u002Fpost measures\n* Use of short-acting opioid analgesics or sedating medications within 24 hours of the study visit\n* Have an implanted device in or near the treatment area that could interfere with safe application of external pressure\n* Have used an investigational drug within 30 days of study enrollment\n* History of any major cardiovascular events including heart valve disease, ongoing angina, cardiac arrhythmias, congestive heart failure, acute coronary syndrome, stroke, transient ischemic attack, or peripheral vascular disease.\n* Clinically significant unstable neurologic or systemic illness that would preclude safe participation, as judged by the investigation team.\n* Surgical intervention for pain within 1 month prior to enrollment\n* Active infection, wound, or other external trauma to the areas to be treated\n* Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence\n* Inability to provide consent",[77,78],"ADULT","OLDER_ADULT",[80],{"facility":81,"city":82,"state":83,"zip":84,"country":85,"geoPoint":86},"Mayo Clinic in Rochester","Rochester","Minnesota","55905","United States",{"lat":87,"lon":88},44.02163,-92.4699,[90],{"name":91,"role":92,"phone":93,"email":94},"Melissa Bush","CONTACT","507-266-1008","Bush.Melissa1@mayo.edu",[96],{"name":97,"affiliation":13,"role":98},"Ziying Yin, Ph.D.","PRINCIPAL_INVESTIGATOR",[],[101],{"label":102,"url":103},"Mayo Clinic Clinical Trials","https:\u002F\u002Fwww.mayo.edu\u002Fresearch\u002Fclinical-trials",{"nct_id":4,"conditions":105,"biomarkers":107},[106],"Chronic low back pain",[],{"nct_id":4,"found":109,"summary":110,"prompt_version":120},true,{"design":111,"status":112,"heading":113,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This is an interventional study planning to enroll 38 participants. It is not specified if it is randomized or blinded.","completed","Magnetic Resonance Elastography of Chronic Low Back Pain Before and After Therapy","This study is looking at how a device called EMMA (Expert Manipulative Massage Automation) affects chronic low back pain. EMMA provides device-assisted massage therapy. Researchers want to see if this massage changes the mechanical properties of your lower back muscles and tissues. You might be able to join if you are an adult (18 or older) with chronic low back pain for at least three months, and your pain level is 4 or higher on a pain scale. The study will measure changes in a mobility index right after the treatment to see if the intervention is successful. The current recruitment status is unclear.","Your mobility will be measured at baseline and 30 minutes after the intervention.",104,"You would receive one 30-minute session of device-assisted massage therapy using EMMA.","Not stated in the trial record.",[32],"v2"]