[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06045936":3,"trial-entities:NCT06045936":105,"trial-summary:NCT06045936":109},{"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":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":49,"sex":60,"minimum_age":61,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":62,"std_ages":77,"locations":80,"central_contacts":96,"overall_officials":97,"references":100,"see_also_links":101},"NCT06045936","22-010792","A Study of Contralateral Limb Block","Sciatic Block in Contralateral Limb for Treatment of Refractory Phantom and Residual Limb Pain; a Double-Blind Randomized Controlled Trial","RECRUITING","2026-12","2026-01","2026-01-06","2024-06-18","Mayo Clinic","OTHER",false,"This research is being done to determine if an anesthetic like Lidocaine, may be effective when injected around the sciatic nerve of the intact limb in patients with limb loss pain on the contralateral side.",null,[19],"Limb Pain, Phantom",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE4",{"count":26,"type":27},20,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","Lidocaine","2 teaspoons of 2% lidocaine injection",[34],"Lidocaine Group",{"type":30,"name":36,"description":37,"armGroupLabels":38},"Placebo","Saline injection",[39],"Sham Group",[41,45],{"measure":42,"description":43,"timeFrame":44},"Change in pain","Measured using self-reported Numerical Rating Scale (NRS) where 0=no pain and 10=worst pain.","Baseline, 60 minutes post injection",{"measure":46,"description":47,"timeFrame":48},"Change in Functional Improvement","Measured using self-reported 20-item Orthotic and Prosthetics User's Survey (OPUS) Lower Extremity Functional Status Measurement survey. Total scores range from 0-100 scale with higher scores indicating a better outcome.","Baseline, 5 days post-injection",[50,53,56],{"measure":51,"description":52,"timeFrame":48},"Change in disability","Measured using self-reported 18-item The Groningen Activity Restriction Scale (GARS) that is a general disease independent instrument for measuring disability. Total scores range from 18-72. The higher the score the greater the disability.",{"measure":54,"description":55,"timeFrame":48},"Change in Pressure-Pain Algometry","Qualified study personnel will measure pain pressure threshold three times at each visit with an algometer on the participant's residual limb at the point of a maximal pain as indicated by the participant during pre-block physical examination, reported in kilopascal (kPa).",{"measure":57,"description":58,"timeFrame":59},"Step Count","Number of daily steps recorded by Modus StepWatch™ or Evolution EvoWalk™ fitted to the participant's prostheses","5 days post-injection","ALL","18 Years",{"inclusion":63,"exclusion":68,"raw_text":76},[64,65,66,67],"Lower extremity amputation performed more than 12 months before study enrollment","PLP\u002FRLP in affected amputated limb \\> 4 on NRS26","Pain duration of more than 6 months despite a trial of conservative therapies for at least 2 months, including oral medications, topical medicines, physical therapy, and physical modalities (i.e., heat, cold, transcutaneous electrical nerve stimulation, phonophoresis)","Willingness to undergo image guided diagnostic nerve block",[69,70,71,72,73,74,75],"Refusal \u002F inability to participate or provide consent","Contraindications to diagnostic nerve block","Non-neurogenic source of PLP\u002FRLP","Current opioid use \\> 50 morphine milligram equivalents per day","Any interventional pain treatment in the residual limb within the last 30 days","Severe uncontrolled medical condition (i.e., hypertensive crisis, decompensated hypothyroidism)","Use of investigational pain drug within past 30 days or other concurrent clinical trial enrollment","Inclusion Criteria:\n\n* Lower extremity amputation performed more than 12 months before study enrollment\n* PLP\u002FRLP in affected amputated limb \\> 4 on NRS26\n* Pain duration of more than 6 months despite a trial of conservative therapies for at least 2 months, including oral medications, topical medicines, physical therapy, and physical modalities (i.e., heat, cold, transcutaneous electrical nerve stimulation, phonophoresis)\n* Willingness to undergo image guided diagnostic nerve block\n\nExclusion Criteria:\n\n* Refusal \u002F inability to participate or provide consent\n* Contraindications to diagnostic nerve block\n* Non-neurogenic source of PLP\u002FRLP\n* Current opioid use \\> 50 morphine milligram equivalents per day\n* Any interventional pain treatment in the residual limb within the last 30 days\n* Severe uncontrolled medical condition (i.e., hypertensive crisis, decompensated hypothyroidism)\n* Use of investigational pain drug within past 30 days or other concurrent clinical trial enrollment",[78,79],"ADULT","OLDER_ADULT",[81],{"facility":82,"status":8,"city":83,"state":84,"zip":85,"country":86,"contacts":87,"geoPoint":93},"Mayo Clinic Health System - Mankato","Mankato","Minnesota","56001","United States",[88],{"name":89,"role":90,"phone":91,"email":92},"Cole Cheney, MD","CONTACT","5156816338","cheney.cole@mayo.edu",{"lat":94,"lon":95},44.15906,-94.00915,[],[98],{"name":89,"affiliation":13,"role":99},"PRINCIPAL_INVESTIGATOR",[],[102],{"label":103,"url":104},"Mayo Clinic Clinical Trials","https:\u002F\u002Fwww.mayo.edu\u002Fresearch\u002Fclinical-trials",{"nct_id":4,"conditions":106,"biomarkers":108},[107],"Phantom Limb Pain",[],{"nct_id":4,"found":110,"summary":111,"prompt_version":121},true,{"design":112,"status":113,"heading":114,"summary":115,"follow_up":116,"word_count":117,"commitments":118,"compensation":119,"drugs_mentioned":120},"This interventional study plans to enroll 20 participants to compare Lidocaine to a placebo (saline injection).","completed","A Study of Contralateral Limb Block for Phantom Limb Pain","This study is looking at whether an anesthetic called Lidocaine can help reduce limb pain, including phantom limb pain (pain felt in a missing body part), when injected near a nerve in the intact leg. Researchers want to see if this injection, compared to a placebo (a saline injection with no active medicine), can improve your pain and how well you can move. You might be able to join if you are 18 or older, have had a lower limb amputation over a year ago, and have experienced significant limb pain or phantom limb pain for more than six months, even after trying other treatments. The study aims to enroll 20 participants, but its current recruitment status is unclear.","Your pain will be measured at baseline and 60 minutes after the injection. Your functional improvement will be measured at baseline and 5 days after the injection.",119,"Not specified in the trial record.","Not stated in the trial record.",[31,36],"v2"]