Symptoms and General Pathology

All Conditions

Nervous System Diseases

Behaviors and Mental Disorders

Neoplasms

Rare Diseases

Pain, Postoperative

Chronic Pain

Pain

Phantom Limb

Acute Pain

Neuroma

Postoperative Complications

Neurologic Manifestations

Perceptual Disorders

Neurobehavioral Manifestations

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Chronic Graft Versus Host Disease

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

Skin and Connective Tissue Diseases

Migraine Disorders

Ganglion Cysts

Headache

Synovial Cyst

Cysts

Headache Disorders

Headache Disorders, Primary

Brain Diseases

Central Nervous System Diseases

Mucinoses

Connective Tissue Diseases

ATI Neurostimulator (NS-100) and Remote Controller (RC-200)

ATI Neurostimulation System

Rigmor Jensen, MD, PhD

The purpose of the clinical study is to evaluate the use of an implanted sphenopalatine ganglion (SPG) neurostimulator for the treatment of migraine headache pain, migraine headache symptoms and migraine frequency in high disability migraineurs.

Pathway M-1: Sphenopalatine Ganglion Stimulation for the AcuteTreatment of High Disability Migraine Headache

Migraine Free Day is any calendar day that:

1. Has less than 4 hours of moderate or severe pain meeting criteria C and D for migraine ICHD-II 1.1 AND
2. No Acute Headache or Migraine Pain Medication is used AND
3. No SPG stimulation is applied for headache pain of any intensity

Headache Free Day is any calendar day that:

1. Has less than 4 hours of moderate or severe pain AND
2. No Acute Headache or Migraine Pain Medication is used AND
3. No SPG stimulation is applied for headache pain of any intensity

Occurrence rate of death, any surgery or hospitalization due to deterioration in subject health, or other Major Device-related Adverse Events

Number of Migraine Pain Days during the Experimental Period, compared between the Treatment and Control arms.

Migraine Pain Day is any calendar day that:

1. Has less than 4 hours of moderate or severe pain meeting criteria C and D for migraine ICHD-II 1.1 AND
2. No Acute Headache or Migraine Pain Medication (pharmacologic medications, not including SPG stimulation, used to treat acute headache pain).

   AND
3. No SPG stimulation is applied for headache pain of any intensity

Autonomic Technologies, Inc.

Digestive System Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

Total mesorectal excision with intraoperative neuromonitoring of pelvic autonomic nerves.

Total mesorectal excision without intraoperative neuromonitoring of pelvic autonomic nerves.

Intraoperative neuromonitoring of pelvic autonomic nerves.

Neuromonitoring

Werner Kneist, Univ.-Prof.

One of the major problems of rectal cancer surgery is pelvic autonomic nerve damage, which is the main cause of urogenital dysfunction influencing postoperative quality of life. Costs for diagnostics and treatment of short and long-term urogenital dysfunction are immense. Varying degrees of urogenital dysfunction are found in up to 32% and 55% of patients with rectal cancer despite potentially nerve-sparing total mesorectal excision (TME).

The study will examine the impact of a newly developed continuous monitoring device for preservation of urogenital function in patients with TME for rectal cancer. 188 patients will be included in the prospective, randomized, single-blind, parallel group multi-centre trial including two arms (TME with and without intraoperative continuous monitoring of pelvic autonomic nerves). The primary efficacy endpoint is the change in urinary function measured by International Prostate Function Score (IPSS) 12 months after surgery. Genital functions measured as secondary endpoints. The application of the continuous intraoperative neuromonitoring device could enhance the objective intraoperative confirmation of pelvic nerve sparing surgery. The investigators hypothesis is that the use of his device minimizes the risk of postoperative urogenital dysfunction in patients with TME for rectal cancer. An enormous reduction of treatment costs is to be expected.

Intraoperative Monitoring of the Pelvic Autonomic Nerves

Continuous Intraoperative Monitoring of the Pelvic Autonomic Nerves During Total Mesorectal Excision (TME) for the Prevention of Urogenital and Anorectal Dysfunction in Patients With Rectal Cancer.

Increase of IPSS score by at least 5 points observed 12 months after surgery compared to the preoperative IPSS score per patient

Reduction of FSFI score by at least 8 points 12 months after surgery compared to the preoperative FSFI score per patient.

Reduction of IIEF score by at least 15 points 12 months after surgery compared to the preoperative IIEF score per patient.

Rates of pCRM-positive specimen (distance of tumour from circumferential resection margin (CRM) ≤ 1mm).

Macroscopic assessment of the resection specimen.

Evaluation of fecal incontinence using the Wexner-Vaizey score

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Pathway M-1: Sphenopalatine Ganglion Stimulation for the AcuteTreatment of High Disability Migraine Headache	NCT01540799	High Frequency,...	ATI Neurostimul...	18 Years -	Autonomic Technologies, Inc.
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
Pathway M-1: Sphenopalatine Ganglion Stimulation for the AcuteTreatment of High Disability Migraine Headache	NCT01540799	High Frequency,...	ATI Neurostimul...	18 Years -	Autonomic Technologies, Inc.
Intraoperative Monitoring of the Pelvic Autonomic Nerves	NCT01585727	Rectal Cancer	TME TME Neuromonitoring	18 Years - 90 Years	Johannes Gutenberg University Mainz

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