Layout table for study information Study Type : Interventional (Clinical Trial) ActualEnrollment : 144 participants Allocation: Randomized Intervention Model: Crossover Assignment Intervention Model Description: The primary endpoint at 4 months following the initial treatment will utilize a parallel group study design; however, an optional crossover is offered to subjects following this time point. Masking: Triple (Participant, Investigator, Outcomes Assessor) Masking Description: All individuals will be masked to treatment with the exception of the anesthesiologist administering the procedure who will choose which probe to use: the functional or sham. Of note, this individual could not be masked to treatment since the cryoneurolysis ice ball is visualized on ultrasound; and, the practitioner would see a lack of ice ball formation for the sham probes. Primary Purpose: Treatment Official Title: Cryoanalgesia to Treat Post-Amputation Phantom Limb Pain: A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Definitive Human Subjects Clinical Trial Actual Study Start Date : March 23, 2018 Actual Primary Completion Date : August 17, 2021 Actual Study Completion Date : March 17, 2022 Arms and Interventions Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Arm Intervention/treatment Active Comparator: CryoneurolysisCryoneurolysis of the femoral and sciatic nerves (or their distal counterparts) in the residual limb: The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods. For active probes, the nitrous oxide will be deployed to the tip where a drop in temperature to -70C will result in cryoneurolysis. Device: CryoneurolysisCryoneurolysis of the femoral and sciatic nerves (or their distal counterparts) in the residual limb: The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods. For active probes, the nitrous oxide will be deployed to the tip where a drop in temperature to -70C will result in cryoneurolysis.Other Name: Cryoanalgesia Sham Comparator: Sham ComparatorSham cryoneurolysis of the femoral and sciatic nerves (or their distal counterparts) in the residual limb: The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods. However, for sham probes, the nitrous oxide is not deployed to the tip and therefore there is no drop in temperature resulting in cryoneurolysis. Device: Sham ComparatorSham cryoneurolysis of the femoral and sciatic nerves (or their distal counterparts) in the residual limb: The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods. However, for sham probes, the nitrous oxide is not deployed to the tip and therefore there is no drop in temperature resulting in cryoneurolysis.Other Name: placebo, control Outcome Measures Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Primary Outcome Measures : Average daily phantom pain intensity [ Time Frame: Baseline and 4 months later (difference between the two is the primary end point) ]The difference in average daily phantom pain intensity at baseline and 4 months following the initial intervention (measured with the NRS as part of the Brief Pain Inventory) Secondary Outcome Measures : Average daily phantom pain intensity [ Time Frame: Endpoints will be evaluated at baseline and post-treatment (Day 0), Days 1 and 7; and Months 1, 2, 3, 4, and 12 [same for crossover subjects with the exception of the 12-month time point] ]The difference in average daily phantom pain intensity at baseline and various time points other than the primary at 4 months Brief Pain Inventory [ Time Frame: Endpoints will be evaluated at baseline and post-treatment (Day 0), Days 1 and 7; and Months 1, 2, 3, 4, and 12 [same for crossover subjects with the exception of the 12-month time point] ]The difference in the Brief Pain Inventory between baseline and various time points Residual limb pain (frequency and duration) [ Time Frame: Endpoints will be evaluated at baseline and post-treatment (Day 0), Days 1 and 7; and Months 1, 2, 3, 4, and 12 [same for crossover subjects with the exception of the 12-month time point] ]Pain that originates from a part of the injured limb that remains intact Patient Global Impression of Change [ Time Frame: Endpoints will be evaluated at baseline and post-treatment (Day 0), Days 1 and 7; and Months 1, 2, 3, 4, and 12 [same for crossover subjects with the exception of the 12-month time point] ]A 7-point scale of change from baseline at various time points Beck Depression Inventory [ Time Frame: At baseline, 4 months, 12 months (and 4 months following crossover for those subjects who choose to the crossover treatment) ]21-question questionnaire evaluating depression with 4-5 multiple choice responses Non-painful phantom sensations (frequency and duration) [ Time Frame: Endpoints will be evaluated at baseline and post-treatment (Day 0), Days 1 and 7; and Months 1, 2, 3, 4, and 12 [same for crossover subjects with the exception of the 12-month time point] ]Sensations that feel to emanate from the missing limb, but are not described as pain Phantom limb pain (frequency and duration) [ Time Frame: Endpoints will be evaluated at baseline and post-treatment (Day 0), Days 1 and 7; and Months 1, 2, 3, 4, and 12 [same for crossover subjects with the exception of the 12-month time point] ]Pain perceived to emanate from part of the injured limb that no longer exists Residual limb pain (NRS) [ Time Frame: Endpoints will be evaluated at baseline and post-treatment (Day 0), Days 1 and 7; and Months 1, 2, 3, 4, and 12 [same for crossover subjects with the exception of the 12-month time point] ]Pain that originates from a part of the injured limb that remains intact. Worst, least, average, and current pain levels will be recorded at each time point Eligibility CriteriaGo to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria:
Ina sense, Murnau's film is about all of the things we worry about at 3 in themorning--cancer, war, disease, madness. It suggests these dark fears in thevery style of its visuals. Much of the film is shot in shadow. The corners ofthe screen are used more than is ordinary; characters lurk or cower there, andit's a rule of composition that tension is created when the subject of a shotis removed from the center of the frame. Murnau's special effects add to thedisquieting atmosphere: the fast motion of Orlok's servant, the disappearanceof the phantom coach, the manifestation of the count out of thin air, the useof a photographic negative to give us white trees against a black sky.
Enter the Phantom Masked Coordinator!!
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