Perioperative Mirror Therapy and Phantom Limb Pain
Açar sözlər
Mücərrəd
Təsvir
Subjects scheduled for amputation will be randomized to either receive perioperative plasma ball (sham) or mirror therapy, which involves a daily session of 30 minutes of performing physical therapy exercises using either a mirror or plasma ball under the supervision of a certified physical therapist. Subjects scheduled to undergo limb amputation who opt in for the fMRI portion of the study will undergo a pre-treatment baseline fMRI (2 weeks prior to scheduled amputation, if possible, but as late as 1 day pre-operative), a post-mirror or sham therapy (preoperative-day before) fMRI, post-operative fMRI at 4 weeks and one year. Performing a baseline fMRI prior to any treatment, will provide objective data regarding the location and extent of cortical involvement prior to initiating mirror therapy. Those subjects randomized to the mirror therapy limb will undergo 14 days of daily mirror therapy sessions preoperatively which will consist of observing the unaffected limb reflected for 30 minutes in a mirror positioned in the midline to block the view of the affected limb. Those randomized to standard therapy will participate in an equivalent period of time undergoing a sham therapy with a 22" plasma globe involving contralateral limb interaction with the sphere. All therapy sessions will be supervised by a physical therapist with the exception of weekends when the patients will continue therapy on an independent basis. The subjects will then undergo a repeat fMRI (or first baseline, depending if pre-operative fMRI was possible) after completion of preoperative mirror or sham therapies and prior to surgical amputation to evaluate for changes suggestive of mirror therapy induced normalization in cortical patterns.
Control subject group will undergo 3 questionnaires and one functional fMRI exam. Imaging protocol will be identical to preoperative imaging protocol for amputation subjects. This data will aid in establishing baseline fMR activation values for all fMR paradigms tested. The control group will not be randomized to receive either perioperative plasma ball (sham) or mirror therapy.
All Subjects scheduled for surgery will then undergo amputation under the anesthetic technique of provider choice. If regional/neuraxial anesthetic techniques are used they will be standardized up to 1 day preoperative and 3 days postoperative. If using dexmedetomidine and/or ketamine infusions, their use will be limit to intraoperative periods at doses of 0.2 mcg/kg/hr and 0.15mg/kg/hr limit respectively. Anesthesiologist/Anesthetist choice will be permitted for all other intraoperative and postoperative meds. Within 1 week of amputation subjects will again repeat 14 days of their respectively assigned therapy limbs as described above in addition to routine post amputation care. All subjects will then be evaluated at four weeks postoperatively with measures delineated in section 5.(Statistics) to determine 1) incidence and severity of phantom limb pain 2) participation in therapy and ability to meet functional endpoints 3) quality of life. These same measures will be assessed at 12 weeks (3 months) and again at one year post procedure. A repeat fMRI will be obtained in those Subjects participating in the fMRI limb in order to evaluate how the postoperative cortical mapping compares to prior preoperative and postoperative studies.
Tarixlər
Son Doğrulandı: | 07/31/2019 |
İlk təqdim: | 03/03/2015 |
Təxmini qeydiyyat təqdim edildi: | 03/08/2015 |
İlk Göndərmə: | 03/09/2015 |
Son Yeniləmə Göndərildi: | 08/25/2019 |
Son Yeniləmə Göndərildi: | 08/27/2019 |
Həqiqi Təhsilin Başlama Tarixi: | 07/31/2010 |
Təxmini İlkin Tamamlanma Tarixi: | 07/31/2019 |
Təxmini İşin Tamamlanma Tarixi: | 07/31/2019 |
Vəziyyət və ya xəstəlik
Müdaxilə / müalicə
Device: Plasma Ball (Control)
Device: Experimental
Faza
Qol Qrupları
Qol | Müdaxilə / müalicə |
---|---|
Sham Comparator: Plasma Ball (Control) Subjects randomized to standard therapy will participate 14 days of daily mirror therapy sessions preoperatively which will consist of undergoing a sham therapy with a 22" plasma globe involving contralateral limb interaction with the sphere. | Device: Plasma Ball (Control) will consist of undergoing a sham therapy with a 22" plasma globe involving contralateral limb interaction with the sphere. |
Experimental: Experimental Subjects randomized to the mirror therapy limb will undergo 14 days of daily mirror therapy sessions preoperatively which will consist of observing the unaffected limb reflected for 30 minutes in a mirror positioned in the midline to block the view of the affected limb. | Device: Experimental will undergo 14 days of daily mirror therapy sessions preoperatively which will consist of observing the unaffected limb reflected for 30 minutes in a mirror positioned in the midline to block the view of the affected limb |
No Intervention: Non-Surgical Subjects will undergo 3 questionnaires and one functional fMRI exam. Imaging protocol will be identical to preoperative imaging protocol for amputation subjects. This data will aid in establishing baseline fMR activation values for all fMR paradigms tested. The control group will not be randomized to receive either perioperative plasma ball (sham) or mirror therapy. |
Uyğunluq Kriteriyaları
Təhsil üçün uyğun yaşlar | 18 Years Üçün 18 Years |
Təhsilə Uyğun Cinslər | All |
Sağlam Könüllüləri qəbul edir | Bəli |
Kriteriyalar | Inclusion Criteria: Treatment (Surgical) Group: 1. Subjects age 18 years or older scheduled for elective amputation; 2. Cooperative, patient scheduled for amputation, with time and availability to do fMRI prior to their operative date; 3. Willing to perform mirror therapy for 14 days prior and post-operative procedure; 4. Subjects who opt for fMRI portion of the study are willing and/or able to tolerate fMRI. Control (Non-Surgical) Group: 1. Subjects age 18 years to 30; 2. who are non amputated and healthy; 3. Cooperative, with time and availability to do an fMRI; 4. Willing and able to tolerate fMRI. Exclusion Criteria: 1. inability to cooperate with physical therapy; and 2. possessing a contraindication to mirror therapy for example blindness or inability to position properly for the therapy 3. primary central nervous disease such as status post cerebral vascular accident with persistent deficit, Alzheimer's disease or Multiple Sclerosis. In addition, patients with claustrophobia will be excluded from participating in the fMRI portion of this study. |
Nəticə
İlkin nəticə tədbirləri
1. Comparing fMRI scans to see if mirror therapy helps prevent or alleviate phantom limb pain in service members undergoing amputation(s) [4 weeks prior to surgery through 1 year post operation]