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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Up to 60 days of peripheral nerve stimulation
Medications, physical therapy, or other pain treatments
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States
Average Phantom Limb Pain (PLP) Score
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.
Time frame: Baseline, Weeks 1-4, Weeks 5-8, and Month 3.
Average Residual Limb Pain (RLP) Score
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.
Time frame: Baseline, Weeks 1-4, Weeks 5-8, and Month 3
Worst Phantom Limb Pain (PLP) Score
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.
Time frame: Baseline, Weeks 1-4, 5-8, and Month 3
Worst Residual Limb Pain (RLP) Score
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.
Time frame: Baseline, Weeks 1-4, Weeks 5-8, and Month 3
Best Phantom Limb Pain (PLP) Score
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.
Time frame: Baseline, Weeks 1-4, Weeks 5-8, and Month 3
Best Residual Limb Pain (RLP) Score
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.
Time frame: Baseline, Weeks 1-4, Weeks 5-8, and Month 3
Number Taking Opioids
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.
Time frame: Preop, Hospital Discharge, Weeks 1-4, Weeks 5-8, Week 12
Average Oral Morphine Equivalents (OME)
Opioid consumption (daily OME) over time was collected for all subjects.
Time frame: Preoperative, Hospital discharge, Weeks 1-4, Weeks 5-8, and Week 12
Functional Independence Measure (FIM) Scores
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.
Time frame: Preoperative, Week 4, and Week 8
Pain Interference
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.
Time frame: Baseline, Weeks 4, 8, and 12
Patient Global Impression of Change (PGIC)
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.
Time frame: Weeks 4, 8, and 12
Pain Catastrophizing Scale (PCS)
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.
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Time frame: Baseline, Weeks 4, 8, and 12
Pain Disability Index (PDI)
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.
Time frame: Weeks 4, Week 8, and Week 12
30-day Readmission Rate
Percent of Group that was readmitted to the hospital within 30 days following hospital discharge.
Time frame: 30 days from hospital discharge
Hospital Length of Stay (LOS)
Hospital LOS was calculated from day of surgery to day of discharge from inpatient hospital ward to rehabilitation facility.
Time frame: Number of days from surgery to discharge