[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05657964":3,"trial-entities:NCT05657964":109,"trial-summary:NCT05657964":113},{"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":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":36,"secondary_outcomes":47,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":15,"eligibility_criteria":59,"std_ages":76,"locations":79,"central_contacts":95,"overall_officials":102,"references":107,"see_also_links":108},"NCT05657964","60640","Randomized Trial for cLBP (Gokhale Project)","A Randomized Comparative Effectiveness Trial of Two Postural Therapies for People With Chronic Lower Back Pain (cLBP)-Gokhale Project","RECRUITING","2030-12-31","2026-01","2026-01-09","2024-07-01","Stanford University","OTHER",false,"The study aims to compare the effectiveness of the Gokhale Method posture therapy for low back pain (LBP) management to standard physical therapy (PT) with posture training. The second aim of this study is to evaluate usability and user adherence of the online\u002Fdigital intervention through the Gokhale Method Foundation Class (online delivery with smartphone App).\n\nThe investigator hopes to learn:\n\nThe effectiveness of the Gokhale Method posture therapy for low back pain management, in comparison to the effectiveness of standard physical therapy with posture training.\n\nthe usability and user adherence of the online\u002Fdigital intervention through the Gokhale Method Foundation Class (online delivery with smartphone App).","100 participants with chronic low back pain will be recruited through the Stanford PMR clinics (Redwood City, Emeryville, Los Gatos, and Palo Alto). Information about the study will also be disseminated to the Stanford Primary Care clinics and through community advertisements.\n\nPatients will be referred to the reaserch team by the providers who is been recommended for Physical Therapy.\n\nResearch team personnel will approach the recommended patients via email and will screen them prior to consenting for eligibility criteria by sending out a set of questionnaires via Redcap.\n\nEligible patients will be consented remotely via Redcap and will be subjected to randomization.\n\nEligible and consented participants will be randomly assigned (1:1) into one of the two intervention groups. Prior to intervention, participants will be asked to complete questionnaires on demographics, self-reported levels of pain, functional status, and disability levels. The questionnaires include:\n\nRoland Morris Disability Questionnaire (RMDQ), Numeric Pain Rating Scale (NPRS), Patient-Reported Outcomes Measurement Information System (PROMIS-29),\n\nParticipants will be randomized (1:1) into the Gokhale method posture treatment (Gokhale) arm will receive a 18-sessions coaching under the Gokhale Elements course (may spread between 6-12 weeks, 1- 2 times per week, online delivery). Participants randomized into the standard care\u002Fphysical therapy (PT) arm will similarly receive a standardized PT prescription during a 6-12 weeks period, meeting 1-2 times per week, to include posture education and training, therapeutic exercise instructions and development of an independent home exercise program.\n\nParticipants enrolled in the Gokhale Arm will be provided the Gokhale PostureTracker, a wearable posture monitoring sensor developed for interactive posture coaching, and a loaner smartphone with pre-installed App. Participants will be provided instruction to apply the sensor on their lumbar area and receive real-time visual feedback on their posture kinematic during the class. Participants can also perform normal daily activities while wearing the device. Data collected by the sensor will be sent to a HIPAA compliance server and shared with Stanford researchers.\n\nParticipant will complete remote follow-up assessments upon completion of their respective intervention, and at 6, and 12-month post intervention.\n\nPrimary outcomes assessed at baseline and each follow-up include the RMDQ,NPRS, PROMIS-29, PCS Secondary outcomes at each timepoint include 1) patient satisfaction and adherence. 2) Type, incidence and severity of complications and adverse events. 3) Concurrent pain medication use (including opioids) All collected data will be stored in a Stanford-secured server. No data would be transmitted to a third party. Access to the data will be limited exclusively to members of the research team.",[19],"Lower Back Pain Chronic",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},100,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":34},"DEVICE","Gokhale sensor","Participants enrolled in the Gokhale Arm will be provided the Gokhale PostureTracker, a wearable posture monitoring sensor developed for interactive posture coaching, and a loaner smartphone with pre-installed App. Participants will be provided instruction to apply the sensor on their lumbar area and receive real-time visual feedback on their posture kinematic during the class. Participants can also perform normal daily activities while wearing the device. Data collected by the sensor will be sent to a HIPAA compliance server and shared with Stanford researchers.",[33],"Gokhale ARM",[35],"Only for Gokhale ARM",[37,41,44],{"measure":38,"description":39,"timeFrame":40},"NPRs ( national pain score)","Average pain score related to lower back","6-12 weeks",{"measure":42,"description":43,"timeFrame":40},"PROMIS-29 questionnaire","Patient-Reported Outcomes Measurement Information System",{"measure":45,"description":46,"timeFrame":40},"RMDQ questionnaire","Roland Morris Disability Questionnaire",[48,52,54],{"measure":49,"description":50,"timeFrame":51},"patient satisfaction and adherence","Post study evaluation of patient's satisfaction.","12 months",{"measure":53,"timeFrame":51},"Type, incidence and severity of complications and adverse events",{"measure":55,"timeFrame":51},"Concurrent pain medication use (including opioids)","ALL","18 Years","65 Years",{"inclusion":60,"exclusion":66,"raw_text":75},[61,62,63,64,65],"18-65 years old (working age population).","NPRS score 4 or more for lower back.","RMDQ score 7 and above.","English speaking population","Need insurance",[67,68,69,70,71,72,73,74],"Pregnancy (as stated by patient)","With cognitive or communication impairment .","Patients recommended for surgery","Participating in other form of intervention.","Prior history of chronic neurological disorder that impacts mobility (e.g. stroke, Parkinson's disease, multiple sclerosis)","Fibromyalgia","Underwent PT treatment for low back pain in the last 6 months","Underlying mental disorder\u002Funtreated depression or presence of neurologic disorders such as MS, Alzheimers, Parkinsons","Inclusion Criteria:\n\n* 18-65 years old (working age population).\n* NPRS score 4 or more for lower back.\n* RMDQ score 7 and above.\n* English speaking population\n* Need insurance\n\nExclusion Criteria:\n\n* Pregnancy (as stated by patient)\n* With cognitive or communication impairment .\n* Patients recommended for surgery\n* Participating in other form of intervention.\n* Prior history of chronic neurological disorder that impacts mobility (e.g. stroke, Parkinson's disease, multiple sclerosis)\n* Fibromyalgia\n* Underwent PT treatment for low back pain in the last 6 months\n* Underlying mental disorder\u002Funtreated depression or presence of neurologic disorders such as MS, Alzheimers, Parkinsons",[77,78],"ADULT","OLDER_ADULT",[80],{"facility":81,"status":8,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":92},"Outpatient Surgery Center\u002FStanford Spine Clinic","Redwood City","California","94063","United States",[87],{"name":88,"role":89,"phone":90,"email":91},"Susmita Chatterjee, MS\u002FCCRP","CONTACT","6504979271","susmitac@stanford.edu",{"lat":93,"lon":94},37.48522,-122.23635,[96,100],{"name":97,"role":89,"phone":98,"email":99},"Ruopeng Sun, PHD","6507217600","rusun@stanford.edu",{"name":101,"role":89,"phone":90,"email":91},"Susmita Chatterjee, MS",[103],{"name":104,"affiliation":105,"role":106},"Matthew Smuck, MD","Stanford PM&R Orthopedic surgery","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":110,"biomarkers":112},[111],"Lower Back Pain",[],{"nct_id":4,"found":114,"summary":115,"prompt_version":125},true,{"design":116,"status":117,"heading":118,"summary":119,"follow_up":120,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"This is an observational study with 100 participants. You will be randomly assigned to one of two groups: the Gokhale Method or standard physical therapy.","completed","Observational Study for Chronic Lower Back Pain","This study is looking for 100 adults, aged 18-65, with chronic lower back pain (pain lasting a long time) to compare two ways of managing it. You might be eligible if your pain and disability scores are above a certain level and you speak English. The study will compare the Gokhale Method posture therapy, which uses a wearable sensor called the Gokhale PostureTracker and a smartphone app, to standard physical therapy with posture training. Researchers want to see how well each method reduces pain and improves your daily function, and how easy the online Gokhale Method is to use.","Your pain and function will be measured at 6-12 weeks after starting the intervention.",99,"If you are in the Gokhale Method group, you will receive 18 coaching sessions over 6-12 weeks, delivered online. You will also complete questionnaires about your pain and function at the beginning and after 6-12 weeks.","Not stated in the trial record.",[],"v2"]