Nervous System Diseases

Symptoms and General Pathology

All Conditions

Behaviors and Mental Disorders

Neoplasms

Rare Diseases

Neuralgia

Pain

Phantom Limb

Neuroma

Peripheral Nervous System Diseases

Neuromuscular Diseases

Neurologic Manifestations

Perceptual Disorders

Neurobehavioral Manifestations

Pain, Postoperative

Postoperative Complications

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Chronic Graft Versus Host Disease

Ten amputees will recieve magnetic resonance-guided focused ultrasound (MRgFUS) treatment aimed to ablate neromas, which are beleived to cuase phantom / residual limb pain

Ten amputees wil recieve a magnetic resonance-guided focused ultrasound treatment aimed at ablating neuromas, which are believe to contribute to their phantom / residual limb pain

Magnetic resonance-guided focused ultrasound

Elon Eisenberg, Prof

Elon Eisenberg

AIM: To provide initial information on the efficacy (pain reduction) and safety of focused ultrasound surgery for the ablation of stump neuromas in amputees with chronic neuropathic pain.

PARTICIPANTS: The study will include 10 amputees (men/women age \>18 years old) with chronic (\>3 months) phantom/residual limb pain (NPS ≥ 4).

DESIGN: Patients potentially qualifying for the study will be offered an Informed Consent to sign prior to further evaluation. Those who accept will sign the informed consent, complete study questionnaires and be evaluated in terms of inclusion/exclusion criteria. Specifically, a complete medical history will be obtained to determine the patient's general health status, current symptoms, frequency and dosage of their current analgesic intake etc. Baseline pain scores will be established. If not performed within six months prior to the evaluation, a contrast MRI of the stump will be performed. Patients not meeting the study criteria will be exited from the study as screen failures and not be included in analyses. All qualifying patients will complete a baseline MRI exam on treatment day. Any patient not meeting study criteria at Imaging will be exited as screen failures.

After completion of the MRI exam, qualifying patients will proceed to the ExAblate treatment. These patients will then be followed for 6-months post-ExAblate treatment; the patients will complete study follow-up questionnaires at 1, 3 days, 1 and 2 weeks, and 1, 3 and 6 months after treatments. Follow-up visits will take place 1 week and 1, 3 and 6 months after treatment to assess their pain status, their quality of life and safety. Data regarding dosage and frequency of analgesic intake for the management of post amputation NP will be collected. Relevant cost data will be collected in order to enable an assessment of the total cost of the procedure.

I. BACKGROUND:

In 2005, 1.6 million people were estimated to be living with limb loss (3). Up to 70% of the patients who undergo limb amputation develop chronic phantom/residual limb pain. A state-of-art understanding of the pathophysiologic basis underlying post-amputation pain suggests that neuroma formation by regenerative sprouting, leading to increased ectopic afferent input is the predominant mechanism involved in NP. Post-amputation pain is often persistent, resistant to treatment and leads to considerable disability. Therefore, new "anti-nueromas" treatments are required.

Magnetic resonance-guided focused ultrasound (MRgFUS) is a non-invasive procedure that combines two technologies:

* Focused ultrasound (FUS) waves which are converted to thermal energy at precise focal point, causes tissue temperature increase, resulting in irreversible thermal ablation of the tissue.
* MRI: Three-dimensional imaging of the tissue and the ultrasound beam in real time enhances the safety and effectiveness of the procedure by allowing:

  * Anatomical planning of the treatment.
  * Real time thermal imaging enables of the and its surrounding tissues. The safety and effectiveness of MRgFUS has been shown in a prospective, randomized (3:1), two-arm, sham-controlled, multicenter, international clinical study with a sham-crossover option in patients with metastatic bone pain, who were not suitable candidates for radiation therapy. A much higher proportion of MRgFUS patients than controls were responders (65.2% vs 18.9%).

II. AIMS:

To provide initial information on the efficacy (pain reduction) and safety of focused ultrasound surgery for the ablation of stump neuromas in amputees with chronic neuropathic pain.

III. PARTICIPANTS:

The study will include 10 amputees with chronic phantom/residual limb pain.

Inclusion Criteria

1. Men and women amputees, aged 18 and older
2. Patients who are able and willing to give consent and able to attend all study visits
3. Patients who are suffering from post-amputation phantom/residual limb pain for at least 3 months
4. Patient with average pain intensity on a 0-10 numerical pain scale (NPS) ≥ 4 during a 3 days period prior to enrollment irrespective of medication use
5. Patient whose targeted (treated) lesion is deeper than 10-mm from the skin
6. Targeted (treated) neuroma is clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible Exclusion Criteria

1. Patients with any acute or unstable medical condition that is expected to hinder them from completing this study 2. Patients with standard contraindications for MR imaging. 3. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease 4. Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment 5. Are participating or have participated in another clinical trial in the last 30 days 6. Patients with persistent undistinguishable pain (pain source unidentifiable) 7. Patients whose neuroma is \< 10-mm from the skin, blood vessels or bone 8. Patients with more than three neuromas in the affected limb 9. Targeted (treated) neuroma is NOT visible by non-contrast MRI 10. Targeted neuroma is not accessible to ExAblate due to scar tissue or any other reason

IV. STUDY DESIGN Patients potentially qualifying for the study will be offered an Informed Consent to sign prior to further evaluation. Those who accept will sign the informed consent, complete study questionnaires and be evaluated in terms of inclusion/exclusion criteria. Specifically, a complete medical history will be obtained to determine the patient's general health status, current symptoms, frequency and dosage of their current analgesic intake etc. Baseline pain scores will be established. If not performed within six months prior to the evaluation, a contrast MRI of the stump will be performed. Patients not meeting the study criteria will be exited from the study as screen failures and not be included in analyses. All qualifying patients will complete a baseline MRI exam on treatment day. Any patient not meeting study criteria at Imaging will be exited as screen failures.

Qualifying patients will proceed to the ExAblate treatment. These patients will then be followed for 6-months post-ExAblate treatment; patients will complete study follow-up questionnaires at 1, 3 days, 1 and 2 weeks, and 1, 3 and 6 months after treatments. Follow-up visits will take place 1 week and 1, 3 and 6 months after treatment to assess their pain status, their quality of life and safety. Data regarding dosage and frequency of analgesic intake for the management of post amputation NP will be collected.

Outcome measures Primary endpoint: Change from baseline in the average daily pain intensity, measured for 3 consecutive days, on the Numerical Pain Scale (NPS), an 11-point numeric rating scale.

Secondary endpoints:

* Change from baseline in the maximum daily pain intensity, measured for 3 consecutive days, on the NPS.
* Change from the baseline in the minimum daily pain intensity, measured for 3 consecutive days, on the NPS.
* Change from the baseline in the consumption of analgesic medications used for the post amputation NP (i.e., increase, unchanged, decreased).
* Change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) score
* Change from the baseline in the Pittsburgh sleep quality index (PSQI).
* Change from the baseline in the European Quality of Life Five-Dimensional (EQ-5D) questionnaire.
* Change from the baseline in the Brief Pain Inventory (BPI).
* Clinician's Global Impression of Change from the baseline.
* Patient's Global Impression of Change from the baseline.
* Change from the baseline in MRI findings in the treated neuroma(s).

Treatment Procedure

* Baseline MRI examinations (without contrast) will be performed to identify the neuroma size, location and extent and device accessibility as well as to evaluate the patient's ability to cooperate during the ExAblate procedure. If at this point it is determined that the patient does not meet all Inclusion and Exclusion criteria and cannot be treated, the patient will be exited from the study. These patients will be considered screening failures, and will not be included in any of the safety or efficacy endpoint analyses.
* If the patient meets all study criteria, the patient will have the ExAblate treatment during this same MRI examination session.
* An IV line will be positioned for the delivery of medications and will be maintained throughout the procedure. Monitoring of heart rate and pO2 will be maintained throughout the procedure using standard MR-compatible monitoring devices. The patients' skin will be closely examined for hair in the treatment path. If necessary, the hair will be removed around the treatment area and the skin will be cleaned, for example with alcohol, from any oil based skin product. Degassed water and possibly an acoustic gel pad will be placed atop of the transducers' window to generate acoustic coupling.
* Patients will be positioned on the ExAblate therapy bed in a selected position according to the planned treatment area. The patient's area of treatment may be placed in a special-purpose imaging coil and positioned in the magnet in the treatment position.
* An MRI scan will be performed with T2 and T1 weighted sequences in all three orientations to localize and measure the target neuroma(s) to be treated.
* Any prior scar will be identified on the image and the ultrasound treatment plan will be planned to avoid sonicating through the scar whenever possible.
* If the neuroma(s) to be treated is identifiable on the MR images, accessible by the device for treatment, and the patient meets all inclusion and exclusion criteria, treatment planning will begin.
* The physician will trace the neuroma(s) in the targeted area.
* The physician will draw the treatment volume using MR images from one or more scan orientations using the following guidelines:
* Up to three well defined neuromas can be treated.
* A central point on the neuroma (depending on patient anatomy) will be sonicated with a low thermal dose, to verify targeting accuracy in the patient. Target placement and transducer positioning will be adjusted as necessary.
* If at this point it is determined that the patient cannot be treated, he or she will be withdrawn from the magnet and the IV line and pulse oximeter will be removed. The patient will be taken to the recovery area for observation and release. Follow-up will consist of a phone call at 1-week post treatment. These patients will be considered screen failures and will not be included in the efficacy analysis.
* Prior to the delivery of any treatment sonications the patient will receive analgesia and sedation or other measures to reduce pain and limit patient motion, and help alleviate anxiety and claustrophobia. Monitoring of heart rate and pO2 saturation will be maintained throughout the procedure.
* Treatment will begin. Sonications will be performed on successive points \[sonication duration between 15 - 60 sec\]. The effect of each sonication will be measured by MR using phase map imaging, reflecting the temperature-dependent change in the proton resonance frequency. Acoustic power will be adjusted throughout the treatment, to achieve temperature between 65 and 85 degrees from MR thermal images at the targeted neuroma.
* Sonications will continue until the prescribed targeted area has been treated. The goal is that the total time from 1st to last sonication will be limited to 180-minutes, or to patient tolerance.
* If no more than 3 planned sonications can be performed using therapeutic energies, then these patients will be considered as screen failures, and will not be included in the intent-to-treat analysis. However, they will be added to the Safety analyses. Criteria to terminate treatment include patient intolerance to the treatment, targeting difficulties due to patient motion or a decision of the treating physician.
* Immediately post-treatment, a series of MR scans will be performed. The scanning will include T2 weighted sequences and T1 weighted contrast enhanced sequences to evaluate general anatomy and to assess treatment effect.
* The patient will be taken off the therapeutic table and escorted to a recovery area for observation period pending release from hospital.
* All MR exams taken during the study will be archived for later analyses.
* If during the treatment session, the physician did not complete the planned treatment, and determines that it would be to the benefit of the patient to continue treatment at a second session, a second treatment session may be completed within two (2) weeks of the first treatment. However, up to three painful neuromas can be treated under this protocol and the purpose of the second treatment is to complete the original treatment plan. This protocol does not allow for a second treatment due to continued pain at the treated site or the treatment of additional painful lesions. The preparation procedures for the second treatment will be the same as the first. No more than two treatments should be performed within a two (2) week period.

Follow-up Telephone follow-up visits will be completed at 1 and 3 days, and 2 weeks post treatment. Clinic visits will be completed at 1 week and 1, 3 and 6 months post-ExAblate treatment. Patients will be evaluated for general health, efficacy measurements as well as for device/procedure related AEs that may have occurred during the follow-up period. Additional data regarding dosage and frequency of analgesic intake for the management of NP will also be collected. For phone visits, study personnel will contact the patient, inquire about AEs and question the patient according to the pain questionnaire, pain medication intake. The study personnel will then sign and date the completed forms. A follow-up MRI to assess the effects on the treated neuroma(s) will be performed four months after treatment.

Focused Ultrasound Treatment of Stump Neuromas for the Relief of Chronic Post-Amputation Neuropathic Pain

Change from baseline in the average daily pain intensity, measured for 3 consecutive days, on the Numerical Pain Scale (NPS), an 11-point numeric rating scale.

Rambam Health Care Campus

Head, Pain Research Unit

Chronic Pain

Acute Pain

Acute Graft Versus Host Disease

Standard medical therapy and 30 to 60 days of peripheral nerve stimulation starting within 7 days after surgery

Up to 60 days of peripheral nerve stimulation

Peripheral nerve stimulation

Medications, physical therapy, or other pain treatments

Standard Medical Therapy

Denise Lester, MD

Limb loss is frequently associated with postamputation pain that can be challenging to treat and often involves opioids. Advances in the field of neuromodulation has led to development of an intentionally reversible percutaneous peripheral nerve stimulation (PNS) system that has had promising results when treating chronic postamputation pain. PNS may offer sustained pain relief even after the treatment period has ended. Currently, there is no convincing evidence regarding the role of PNS in the acute postoperative period, which may be a critical time to control pain as those with higher pain appear to be at higher risk for developing persistent post-procedural pain. The investigators of this study aim to evaluate the feasibility and effects of PNS in the acute postoperative period and determine the feasibility of completing a randomized controlled treatment outcome study.

16 patients with new nontraumatic transfemoral or transtibial amputation will be enrolled in the study

Having met inclusion criteria, the patients will be randomized to experimental or control groups

Patients in the experimental group undergo placement of PNS leads within 7 days of amputation surgery

Patients in both groups will be treated with standard pharmacologic and nonpharmacologic pain therapies and evaluated weekly for 8 weeks, then at 3, 6, and 12 months postamputation

Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain

Effects of Postoperative Percutaneous Peripheral Nerve Stimulation on Acute and Chronic Amputation Pain

Using the Brief Pain Inventory-Short Form (BPI-SF) questionnaire, subjects were asked to rate their PLP over the past 24 hours on a scale of "0"=no pain to "10"=worst pain they have ever experienced. A lower score is better. Data from Weeks 1-4 and Weeks 5-8 were averaged to obtain a numerical score for these time points.

Using the Brief Pain Inventory-Short Form (BPI-SF) questionnaire, subjects were asked to rate their RLP over the past 24 hours on a scale of "0"=no pain to "10"=worst pain they have ever experienced. A lower score is better. Data from Weeks 1-4 and Weeks 5-8 were averaged to obtain a numerical score for these time points.

The number of subjects prescribed any opioid medication and any dose. Data from Weeks 1-4 and Weeks 5-8 were averaged to obtain a numerical score for these time points.

Opioid consumption (daily OME) over time was collected for all subjects.

FIM mobility subscores were recorded by a physical therapist to measure the ability to walk, use a wheelchair, transfer to tub/shower, transfer to toilet, and mobility in bed, chair, and wheelchair. Scores range from "1" = subject requires total assistance for the task to "7" = complete independence. A higher score is better.

Using the Brief Pain Inventory-Short Form (BPI-SF) questionnaire, subjects were asked to rate how much pain has interfered with daily activities over the past 24 hours on a scale of "0" = no interference to "10" = completely interferes with activities. A lower score is better.

Self-report measure PGIC reflects a patient's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as

1 = "very much improved," 2 = "much improved," 3 = "minimally improved," 4 = "no change," 5 = "minimally worse," 6 = "much worse," or 7 = "very much worse." A lower score is better.

Pain catastrophizing is the tendency to magnify the threat value of a pain stimulus and to feel helpless in the presence of pain. This is further characterized by the inability to prevent or inhibit pain-related thoughts surrounding a painful event. Pain catastrophizing affects how individuals experience pain. The PCS is a 13-item inventory of statements in which the subject is asked to rate the degree to which they agree, on a scale of "0" = not at all to "4" = all the time. The responses for each item are added for a total PCS score (range 0-52). A lower score is better.

The PDI is designed to measure the degree to which aspects of life are disrupted by chronic pain. The impact of pain on various aspects of life (e.g. family/home responsibilities, recreation, social activity, occupation, sexual behavior, self-care, and life-support activities) are recorded on a 10-point scale from "0" = no disability to "10" = worst disability. The sum of scores is recorded for a total PDI score (range 0-70). A lower score is better.

Percent of Group that was readmitted to the hospital within 30 days following hospital discharge.

Hospital LOS was calculated from day of surgery to day of discharge from inpatient hospital ward to rehabilitation facility.

Hunter Holmes Mcguire Veteran Affairs Medical Center

Subjects in the Control Group were not at risk for PNS Lead Reimplantation because they did not undergo implantation of any peripheral nerve stimulator leads. Other \[Not Including Serious\] Adverse Events were not monitored/assessed in the Control Arm/Group.

Up to 60 days of PNS starting within 7 days after major lower limb amputation surgery. Subjects also received standard medical therapy (SMT). SMT is defined as pharmacotherapy, physical therapy, or other therapies.

Peripheral Nerve Stimulation (PNS)

Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.

Control

Total

Age, Categorical

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Perineural Catheter Infusion

Taking Opioids Preoperatively

Level of Amputation

Indication for Surgery

Several participants underwent unanticipated amputation revisions, which has the potential to contribute to worsening pain and the need for increased opioids, which may significantly confound results. Subjects were instructed to use the device continuously, and the effects of PNS therapy may be impacted by the number of hours the device was utilized by the patient. Variations in subject compliance with device usage may impact outcomes.

Dr. Denise Lester

Baseline

Weeks 1-4

Weeks 5-8

Month 3

Subjects who completed up to 60 days of peripheral nerve stimulation (PNS) and standard medical therapy (SMT) or (SMT) only.

Average Phantom Limb Pain (PLP) Score

Average Residual Limb Pain (RLP) Score

Worst Phantom Limb Pain (PLP) Score

Worst Residual Limb Pain (RLP) Score

Best Phantom Limb Pain (PLP) Score

Best Residual Limb Pain (RLP) Score

Hospital Discharge

Week 12

Between Weeks 1-4 and Weeks 5-8, three subjects in the PNS Group terminated due to unrelated medical events (2) or withdrew consent (1). After Week 12, two subjects in the Control Group terminated due to unrelated medical events or withdrew consent (data for one subject was collected prior to withdrawal).

Number Taking Opioids

Preop

Average Oral Morphine Equivalents (OME)

Walk (Preop)

Walk (Week 4)

Walk (Week 8)

Wheelchair (Preop)

Wheelchair (Week 4)

Wheelchair (Week 8)

Tub/Shower Transfer (Preop)

Tub/Shower Transfer (Week 4)

Tub/Shower Transfer (Week 8)

Toilet Transfer (Preop)

Toilet Transfer (Week 4)

Toilet Transfer (Week 8)

Bed/Chair/Wheelchair Mobility (Preop)

Bed/Chair/Wheelchair Mobility (Week 4)

Bed/Chair/Wheelchair Mobility (Week 8)

Functional Independence Measure (FIM) Scores

Week 4

Week 8

Subjects who were enrolled in the study and for whom this data was collected.

Pain Interference

Patient Global Impression of Change (PGIC)

Pain Catastrophizing Scale (PCS)

Pain Disability Index (PDI)

30-day Readmission Rate

Hospital Length of Stay (LOS)

Standard medical therapy and 30 to 60 days of peripheral nerve stimulation starting within 7 days after surgery

Peripheral nerve stimulation: Up to 60 days of peripheral nerve stimulation

Standard Medical Therapy: Medications, physical therapy, or other pain treatments

Standard medical therapy only

Standard Medical Therapy: Medications, physical therapy, or other pain treatments

Standard Medical Therapy (SMT)

Overall Study

Standard Post-Amputation Surgical Care: Briefly, the transected nerves will be blindly tucked into surrounding bulky soft tissue to protect the nerve ends before the wound is closed.

Briefly, each transected nerve is identified after amputation using 6-0 Prolene suture and is dissected proximally for length. With minimal dissection, a nerve stimulator is used to identify functional motor nerve branches. Near the point where the motor branch enters the muscle, the motor nerve branch is transected and an end-to-end coaptation is performed with a nearby tagged amputated nerve.

Briefly, a muscle graft (usually from the amputated limb) is wrapped around the clean ends of the transected nerve(s).

Targeted Muscle Re-innervation involves re-routing transected nerve ends to functional motor nerves proximal to the site of amputation.

Targeted Muscle Re-innervation

Regenerative Peripheral Nerve Interface involves placing transected nerve ends in harvested muscle grafts.

Regenerative Peripheral Nerve Interface

Standard post-amputation surgical care involves placing transected nerve ends into muscle/soft tissue proximal to the site of amputation.

Standard Post-Amputation Surgical Care

Deborah Noble

The purpose of this study is to analyze the efficacy of novel interventions in post-amputation surgical care (specifically Targeted Muscle Reinnervation and Regenerative Peripheral Nerve Interface) on post-amputation pain and functional outcomes at the time of amputation. These novel interventions have been shown to be successful in treating the downstream effects of amputations (pain, phantom limb pain, neuroma pain, etc.), but has not been studied in a randomized manner at the time of amputation.

The investigators plan a randomized control trial of all eligible patients undergoing major limb amputation at Parkland Memorial Hospital. Eligible patients undergoing an amputation will be consented for all possible interventions and randomized to either receive Targeted Muscle Re-Innervation (TMR), Regenerative Peripheral Nerve Interface (RPNI), or standard post-amputation surgical care at the time of their operation. Key pre-operative data including patient sex, age, BMI, past medical history, past surgical history, medications, allergies, social history, social support systems, exposure to narcotic medication, and reason for amputation will be analyzed. Intra-operatively, patients randomized to the treatment arm will receive TMR or RPNI and the transected nerve ends addressed will be recorded. Post-operative data that will be recorded include hospital stay, complications related to the procedure, complications leading to reoperation, functional results, need for pain medication, incidence of phantom limb pain, incidence of painful neuromas, length of follow-up, and all adverse events/complications. Analyses will be conducted using data obtained from patient medical records from the Parkland Health \& Hospital System.

Effect of Prophylactic TMR and RPNI on Neuroma and Phantom Limb Pain

Prophylactic Treatment of Neuroma and Phantom Limb Pain With Targeted Muscle Reinnervation (TMR) and Regenerative Peripheral Interface (RPNI) at the Time of Major Limb Amputation: A Randomized Control Trial

The primary outcome measure of the study will the incidence of phantom limb pain in each group over the course of the recovery period.

Pain intensity score is measured bv PROMIS (Patient Reported Outcomes Measurement Information System) Scores via patient questionnaires administered at follow-up visits. Possible scores range from 1-5 where higher scores indicate worse outcome (pain severity).

Pain interference score as measured by PROMIS (Patient Reported Outcomes Measurement information System) scores via patient questionnaires administered at follow-up visits. Possible scores range from 1-5, where higher scores indicate worse outcome (pain interference).

Pain behavior score measured by PROMIS (Patient Reported Outcomes Measurement Information System) questionnaire that pertains to subject social health. Raw summed score from 8 to 40, where 40 represents severely maladaptive pain behavior.

Narcotic medical use post-operatively as measured by MME (Morphine Milligram Equivalent) Score This is a tool to condense and standardize the patient's narcotic pain regimen.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Focused Ultrasound Treatment of Stump Neuromas for the Relief of Chronic Post-Amputation Neuropathic Pain	NCT03255395	Phantom Limb Pa... Residual Limbs Amputation	Magnetic resona...	18 Years -	Rambam Health Care Campus
Focused Ultrasound Treatment of Stump Neuromas for the Relief of Chronic Post-Amputation Neuropathic Pain	NCT03255395	Phantom Limb Pa... Residual Limbs Amputation	Magnetic resona...	18 Years -	Rambam Health Care Campus
Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain	NCT03484429	Phantom Limb Pa... Postoperative P... Neuroma Acute Pain Chronic Pain Residual Limbs Amputation	Peripheral nerv... Standard Medica...	18 Years -	Hunter Holmes Mcguire Veteran Affairs Medical Center
Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain	NCT03484429	Phantom Limb Pa... Postoperative P... Neuroma Acute Pain Chronic Pain Residual Limbs Amputation	Peripheral nerv... Standard Medica...	18 Years -	Hunter Holmes Mcguire Veteran Affairs Medical Center
Effect of Prophylactic TMR and RPNI on Neuroma and Phantom Limb Pain	NCT05344261	Amputation Neuroma Amputat... Phantom Limb Pa... Residual Limbs	Targeted Muscle... Regenerative Pe... Standard Post-A...	18 Years -	University of Texas Southwestern Medical Center
Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain	NCT03484429	Phantom Limb Pa... Postoperative P... Neuroma Acute Pain Chronic Pain Residual Limbs Amputation	Peripheral nerv... Standard Medica...	18 Years -	Hunter Holmes Mcguire Veteran Affairs Medical Center
Effect of Prophylactic TMR and RPNI on Neuroma and Phantom Limb Pain	NCT05344261	Amputation Neuroma Amputat... Phantom Limb Pa... Residual Limbs	Targeted Muscle... Regenerative Pe... Standard Post-A...	18 Years -	University of Texas Southwestern Medical Center

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