[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566891":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":31,"studyPopulation":20,"armGroups":32,"interventions":49,"overallOfficials":59,"centralContacts":64,"locations":70,"responsibleParty":87,"collaborators":91,"id":95,"slug":20,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":20,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":121,"whyStopped":20,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Wroclaw University of Health and Sport Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Pain changes in pain intensity before and after the intervention","A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patient's current level of shoulder pain, and the worst and lowest level of pain experienced in the preceding week in the shoulder area.","Baseline, immediately after, and 24 after of intervention",[14,17],{"measure":15,"description":16,"timeFrame":12},"Pressure Pain Threshold","Somedic Algometer type 2 was used to measure PPT. The diameter of the contact tip was 10 mm and covered with 2 mm thick rubber. The pressure on point and its rate was standardized (30 kPa s-1 ). The value of the pain threshold equals the value of the pressure at which the examined person reported that the pressure exerted on a certain point causes pain.",{"measure":18,"description":19,"timeFrame":12},"Muscle stiffness","An ultrasound machine with shear-wave elastography Canon Aplio A device, using a linear transducer PLT-1005-BT (Canon Medical Corp, 1385 Shimoishigami, Otawara, Tochigi 324-8550, Japan). The console settings will also be standard for all the acquisitions (Frequency=11 MHz, Gain=78 dB, Dynamic Range=75, and Depth=4.5 cm).",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":24,"primaryPurpose":25,"observationalModel":20,"timePerspective":20,"maskingInfo":26},"RANDOMIZED","PARALLEL","A triple-blinded, pilot randomized controlled trial","TREATMENT",{"masking":27,"maskingDescription":20,"whoMasked":28},"DOUBLE",[29,30],"PARTICIPANT","INVESTIGATOR","A parallel-group, controlled, triple-blinded, randomized pilot clinical trial comparing the effects of a single session of high-intensity percutaneous electrolysis (HIPE), low-intensity percutaneous electrolysis (LIPE), and dry needling (DN) applied to the multifidus muscle most active MTrP in subjects with low back pain. This clinical trial will follow the Consolidated Standards of Reporting Trials for pragmatic clinical trials.\n\nThis procedure consists of three trials, i.e., (1, HIPE) 660 uA x 30\"; (2, LIPE) 220uA x 30\"; and (3, DN) with 1 twitch response, and the needle inserted 30\".",[33,39,43],{"label":34,"type":35,"description":36,"interventionNames":37},"High-intensity percutaneous electrolysis (HIPE)","EXPERIMENTAL","The HIPE group receives a 660 mA galvanic current for 10 s.",[38],"Device: Electrolysis Percutaneous Therapeutic (EPTE)",{"label":40,"type":35,"description":41,"interventionNames":42},"Low-intensity percutaneous electrolysis (LIPE)","The LIPE group receives a 220 mA × 30 s.",[38],{"label":44,"type":45,"description":46,"interventionNames":47},"Dry Needling (DN)","ACTIVE_COMPARATOR","The DN group received no galvanic current.",[48],"Other: Dry Needling",[50,55],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":20},"DEVICE","Electrolysis Percutaneous Therapeutic (EPTE)","EPTE device (Ionclinics, Valencia, Spain)",[34,40],{"type":6,"name":56,"description":57,"armGroupLabels":58,"otherNames":20},"Dry Needling","A dry needle with size 0.30 × 40 (Agupunt, Barcelona, Spain)",[44],[60],{"name":61,"affiliation":62,"role":63},"Juan Antonio Valera-Calero, PhD","Universidad Complutense de Madrid","STUDY_DIRECTOR",[65],{"name":66,"role":67,"phone":68,"phoneExt":20,"email":69},"Sebastian Klich, PhD, DSc","CONTACT","+48713473176","sebastian.klich@awf.wroc.pl",[71],{"facility":72,"status":20,"city":73,"state":20,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Faculty of Nursery, Physiotherapy and Podiatry","Madrid","28040","Spain","ES",{"type":78,"coordinates":79},"Point",[80,81],-3.70256,40.4165,{"lat":81,"lon":80},[84],{"name":61,"role":67,"phone":85,"phoneExt":20,"email":86},"+34913941524","juavaler@ucm.es",{"type":88,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Sebastian Klich","Principal Investigator",[92,93],{"name":62,"class":6},{"name":94,"class":6},"Universidad Rey Juan Carlos","100566891",false,"NCT06661070","Electrolysis in Patients With Low Back Pain","Short-term Effectiveness of High- and Low-intensity Percutaneous Electrolysis in Patients With Low Back Pain","Electrolysis","Inclusion Criteria:\n\n* to report low back pain of at least six months duration,\n* aged 35 to 50 years,\n* at least one active trigger point is present in the multifidus muscle.\n\nExclusion Criteria:\n\n* pharmacological (e.g., analgesics) or physiotherapy treatment before or during their participation in the study,\n* needle fear,\n* prior lower extremity or spine surgery, absence of pain, any musculoskeletal or neuropathic conditions (e.g., peripheral compressive neuropathy, radiculopathy, sarcopenia, fibromyalgia, muscle ruptures), traumatic injuries (e.g., fractures or fissures), or any medical condition or contraindication for needling treatment (e.g., anticoagulants).","ALL","35 Years","50 Years",{"count":106,"type":107},50,"ESTIMATED","INTERVENTIONAL",[110],"NA","The goal of this observational study is to investigate the efficacy of percutaneous electrolysis compared with dry needling on pain sensations and multifidus muscle properties in subjects with low back pain. The main questions it aims to answer are:\n\nThe high-intensity and low-intensity percutaneous electrolysis may induce pressure pain threshold (PPT) changes in myofascial trigger points in the low back during the intervention compared with dry needling.\n\nPercutaneous electrolysis interventions may reduce stiffness in the multifidus muscle during the intervention compared with dry needling.",[113],"Low Back Pain",[115,116,117,118,119,120],"Low Back","Pain","Multifidus muscle","Trigger Points","shear-wave elastography","pain sensitivity","NOT_YET_RECRUITING","2024-10-24",{"date":124,"type":125},"2024-10-28","ACTUAL",{"date":127,"type":107},"2024-11-04",{"date":129,"type":107},"2024-11-23",{"name":5,"class":6},1]