Trial Outcomes & Findings for Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain (NCT NCT03484429)
NCT ID: NCT03484429
Last Updated: 2021-07-21
Results Overview
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.
COMPLETED
NA
16 participants
Baseline, Weeks 1-4, Weeks 5-8, and Month 3.
2021-07-21
Participant Flow
Participant milestones
| Measure |
Peripheral Nerve Stimulation (PNS)
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 (SMT)
Standard medical therapy only
Standard Medical Therapy: Medications, physical therapy, or other pain treatments
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
Postamputation Week 1-4
|
8
|
8
|
|
Overall Study
Postamputation Week 5-8
|
5
|
8
|
|
Overall Study
Postamputation Month 3
|
5
|
7
|
|
Overall Study
COMPLETED
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Peripheral Nerve Stimulation (PNS)
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 (SMT)
Standard medical therapy only
Standard Medical Therapy: Medications, physical therapy, or other pain treatments
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Peripheral Nerve Stimulation (PNS)
n=8 Participants
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.
|
Control
n=8 Participants
Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=16 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
13 Participants
n=16 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
15 Participants
n=16 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
8 participants
n=8 Participants
|
8 participants
n=8 Participants
|
16 participants
n=16 Participants
|
|
Perineural Catheter Infusion
|
6 Days
STANDARD_DEVIATION 1 • n=8 Participants
|
5.5 Days
STANDARD_DEVIATION 2.5 • n=8 Participants
|
5.75 Days
STANDARD_DEVIATION 2.5 • n=16 Participants
|
|
Taking Opioids Preoperatively
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=16 Participants
|
|
Level of Amputation
Above Knee
|
5 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
9 Participants
n=16 Participants
|
|
Level of Amputation
Below Knee
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
7 Participants
n=16 Participants
|
|
Indication for Surgery
Peripheral Vascular Disease (PVD)
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
7 Participants
n=16 Participants
|
|
Indication for Surgery
Peripheral Arterial Disease (PAD)
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=16 Participants
|
|
Indication for Surgery
Pain
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=16 Participants
|
|
Indication for Surgery
Diabetes (DM)
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 1-4, Weeks 5-8, and Month 3.Population: Subjects who completed up to 60 days of peripheral nerve stimulation (PNS) and standard medical therapy (SMT) or (SMT) only.
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.
Outcome measures
| Measure |
Peripheral Nerve Stimulation (PNS)
n=8 Participants
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.
|
Control
n=8 Participants
Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
|
|---|---|---|
|
Average Phantom Limb Pain (PLP) Score
Baseline
|
4.1 score on a scale
Standard Deviation 3.2
|
3.1 score on a scale
Standard Deviation 2.7
|
|
Average Phantom Limb Pain (PLP) Score
Weeks 1-4
|
2.2 score on a scale
Standard Deviation 2.4
|
3.0 score on a scale
Standard Deviation 1.7
|
|
Average Phantom Limb Pain (PLP) Score
Weeks 5-8
|
1.0 score on a scale
Standard Deviation 1.2
|
2.2 score on a scale
Standard Deviation 2.2
|
|
Average Phantom Limb Pain (PLP) Score
Month 3
|
1.0 score on a scale
Standard Deviation 1.2
|
1.3 score on a scale
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: Baseline, Weeks 1-4, Weeks 5-8, and Month 3Population: Subjects who completed up to 60 days of peripheral nerve stimulation (PNS) and standard medical therapy (SMT) or (SMT) only.
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.
Outcome measures
| Measure |
Peripheral Nerve Stimulation (PNS)
n=8 Participants
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.
|
Control
n=8 Participants
Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
|
|---|---|---|
|
Average Residual Limb Pain (RLP) Score
Baseline
|
7.1 score on a scale
Standard Deviation 2.2
|
4.4 score on a scale
Standard Deviation 1.4
|
|
Average Residual Limb Pain (RLP) Score
Weeks 1-4
|
3.6 score on a scale
Standard Deviation 2.5
|
2.2 score on a scale
Standard Deviation 1.6
|
|
Average Residual Limb Pain (RLP) Score
Weeks 5-8
|
1 score on a scale
Standard Deviation 1
|
2.1 score on a scale
Standard Deviation 2
|
|
Average Residual Limb Pain (RLP) Score
Month 3
|
0 score on a scale
Standard Deviation 0
|
1.1 score on a scale
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: Baseline, Weeks 1-4, 5-8, and Month 3Population: Subjects who completed up to 60 days of peripheral nerve stimulation (PNS) and standard medical therapy (SMT) or (SMT) only.
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.
Outcome measures
| Measure |
Peripheral Nerve Stimulation (PNS)
n=8 Participants
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.
|
Control
n=8 Participants
Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
|
|---|---|---|
|
Worst Phantom Limb Pain (PLP) Score
Weeks 1-4
|
3.1 score on a scale
Standard Deviation 3.1
|
5.4 score on a scale
Standard Deviation 2.6
|
|
Worst Phantom Limb Pain (PLP) Score
Weeks 5-8
|
2.2 score on a scale
Standard Deviation 1.6
|
3.6 score on a scale
Standard Deviation 3.3
|
|
Worst Phantom Limb Pain (PLP) Score
Month 3
|
2.2 score on a scale
Standard Deviation 2.7
|
2.0 score on a scale
Standard Deviation 3.2
|
|
Worst Phantom Limb Pain (PLP) Score
Baseline
|
6.5 score on a scale
Standard Deviation 4.4
|
5.9 score on a scale
Standard Deviation 4.0
|
PRIMARY outcome
Timeframe: Baseline, Weeks 1-4, Weeks 5-8, and Month 3Population: Subjects who completed up to 60 days of peripheral nerve stimulation (PNS) and standard medical therapy (SMT) or (SMT) only.
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.
Outcome measures
| Measure |
Peripheral Nerve Stimulation (PNS)
n=8 Participants
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.
|
Control
n=8 Participants
Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
|
|---|---|---|
|
Worst Residual Limb Pain (RLP) Score
Weeks 5-8
|
1.7 score on a scale
Standard Deviation 1.5
|
3.2 score on a scale
Standard Deviation 2.7
|
|
Worst Residual Limb Pain (RLP) Score
Month 3
|
0 score on a scale
Standard Deviation 0
|
1.9 score on a scale
Standard Deviation 2.9
|
|
Worst Residual Limb Pain (RLP) Score
Baseline
|
8.3 score on a scale
Standard Deviation 1.9
|
7.8 score on a scale
Standard Deviation 1.9
|
|
Worst Residual Limb Pain (RLP) Score
Weeks 1-4
|
5.1 score on a scale
Standard Deviation 2.6
|
4.1 score on a scale
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: Baseline, Weeks 1-4, Weeks 5-8, and Month 3Population: Subjects who completed up to 60 days of peripheral nerve stimulation (PNS) and standard medical therapy (SMT) or (SMT) only.
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.
Outcome measures
| Measure |
Peripheral Nerve Stimulation (PNS)
n=8 Participants
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.
|
Control
n=8 Participants
Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
|
|---|---|---|
|
Best Phantom Limb Pain (PLP) Score
Baseline
|
1.4 score on a scale
Standard Deviation 2.1
|
1.3 score on a scale
Standard Deviation 1.6
|
|
Best Phantom Limb Pain (PLP) Score
Weeks 1-4
|
0.8 score on a scale
Standard Deviation 1.1
|
1.4 score on a scale
Standard Deviation 1.4
|
|
Best Phantom Limb Pain (PLP) Score
Weeks 5-8
|
0.6 score on a scale
Standard Deviation 1.0
|
1.1 score on a scale
Standard Deviation 0.9
|
|
Best Phantom Limb Pain (PLP) Score
Month 3
|
0.4 score on a scale
Standard Deviation 0.7
|
1.0 score on a scale
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: Baseline, Weeks 1-4, Weeks 5-8, and Month 3Population: Subjects who completed up to 60 days of peripheral nerve stimulation (PNS) and standard medical therapy (SMT) or (SMT) only.
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.
Outcome measures
| Measure |
Peripheral Nerve Stimulation (PNS)
n=8 Participants
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.
|
Control
n=8 Participants
Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
|
|---|---|---|
|
Best Residual Limb Pain (RLP) Score
Weeks 5-8
|
0.4 score on a scale
Standard Deviation 0.7
|
1.0 score on a scale
Standard Deviation 0.9
|
|
Best Residual Limb Pain (RLP) Score
Month 3
|
0.0 score on a scale
Standard Deviation 0.0
|
0.4 score on a scale
Standard Deviation 1.1
|
|
Best Residual Limb Pain (RLP) Score
Baseline
|
4.1 score on a scale
Standard Deviation 2.6
|
1.5 score on a scale
Standard Deviation 1.5
|
|
Best Residual Limb Pain (RLP) Score
Weeks 1-4
|
1.7 score on a scale
Standard Deviation 1.4
|
1.0 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Preop, Hospital Discharge, Weeks 1-4, Weeks 5-8, Week 12Population: 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).
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.
Outcome measures
| Measure |
Peripheral Nerve Stimulation (PNS)
n=8 Participants
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.
|
Control
n=8 Participants
Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
|
|---|---|---|
|
Number Taking Opioids
Baseline
|
3 Participants
|
2 Participants
|
|
Number Taking Opioids
Hospital Discharge
|
6 Participants
|
7 Participants
|
|
Number Taking Opioids
Weeks 1-4
|
3 Participants
|
5 Participants
|
|
Number Taking Opioids
Weeks 5-8
|
1 Participants
|
4 Participants
|
|
Number Taking Opioids
Week 12
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Preoperative, Hospital discharge, Weeks 1-4, Weeks 5-8, and Week 12Population: All study participants were evaluated.
Opioid consumption (daily OME) over time was collected for all subjects.
Outcome measures
| Measure |
Peripheral Nerve Stimulation (PNS)
n=8 Participants
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.
|
Control
n=8 Participants
Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
|
|---|---|---|
|
Average Oral Morphine Equivalents (OME)
Preop
|
36.1 oral morphine equivalents (mg)
Standard Deviation 60.5
|
7.2 oral morphine equivalents (mg)
Standard Deviation 13.3
|
|
Average Oral Morphine Equivalents (OME)
Hospital Discharge
|
44.1 oral morphine equivalents (mg)
Standard Deviation 57.2
|
36.1 oral morphine equivalents (mg)
Standard Deviation 30.4
|
|
Average Oral Morphine Equivalents (OME)
Weeks 1-4
|
23.4 oral morphine equivalents (mg)
Standard Deviation 47.7
|
16.6 oral morphine equivalents (mg)
Standard Deviation 30.0
|
|
Average Oral Morphine Equivalents (OME)
Weeks 5-8
|
13.5 oral morphine equivalents (mg)
Standard Deviation 24.9
|
20.3 oral morphine equivalents (mg)
Standard Deviation 31.0
|
|
Average Oral Morphine Equivalents (OME)
Week 12
|
13.5 oral morphine equivalents (mg)
Standard Deviation 23.9
|
10.7 oral morphine equivalents (mg)
Standard Deviation 20.7
|
SECONDARY outcome
Timeframe: Preoperative, Week 4, and Week 8Population: All qualifying subjects were evaluated.
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.
Outcome measures
| Measure |
Peripheral Nerve Stimulation (PNS)
n=8 Participants
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.
|
Control
n=8 Participants
Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
|
|---|---|---|
|
Functional Independence Measure (FIM) Scores
Walk (Preop)
|
1 score on a scale
Standard Deviation 0
|
1 score on a scale
Standard Deviation 0
|
|
Functional Independence Measure (FIM) Scores
Walk (Week 4)
|
1 score on a scale
Standard Deviation 0
|
1.2 score on a scale
Standard Deviation 0.4
|
|
Functional Independence Measure (FIM) Scores
Walk (Week 8)
|
1.7 score on a scale
Standard Deviation 1.5
|
1.3 score on a scale
Standard Deviation 0.8
|
|
Functional Independence Measure (FIM) Scores
Wheelchair (Preop)
|
4.8 score on a scale
Standard Deviation 1.6
|
5.4 score on a scale
Standard Deviation 0.7
|
|
Functional Independence Measure (FIM) Scores
Tub/Shower Transfer (Preop)
|
4.1 score on a scale
Standard Deviation 1.6
|
4.1 score on a scale
Standard Deviation 1.1
|
|
Functional Independence Measure (FIM) Scores
Tub/Shower Transfer (Week 4)
|
5.8 score on a scale
Standard Deviation 0.4
|
5.4 score on a scale
Standard Deviation 1.5
|
|
Functional Independence Measure (FIM) Scores
Tub/Shower Transfer (Week 8)
|
5.7 score on a scale
Standard Deviation 0.5
|
5.7 score on a scale
Standard Deviation 0.5
|
|
Functional Independence Measure (FIM) Scores
Toilet Transfer (Preop)
|
4.6 score on a scale
Standard Deviation 0.9
|
3.9 score on a scale
Standard Deviation 1.4
|
|
Functional Independence Measure (FIM) Scores
Toilet Transfer (Week 4)
|
5.8 score on a scale
Standard Deviation 0.4
|
5.0 score on a scale
Standard Deviation 1.7
|
|
Functional Independence Measure (FIM) Scores
Toilet Transfer (Week 8)
|
5.7 score on a scale
Standard Deviation 0.5
|
5.7 score on a scale
Standard Deviation 0.5
|
|
Functional Independence Measure (FIM) Scores
Bed/Chair/Wheelchair Mobility (Week 8)
|
5.7 score on a scale
Standard Deviation 0.5
|
6.0 score on a scale
Standard Deviation 0.0
|
|
Functional Independence Measure (FIM) Scores
Wheelchair (Week 4)
|
5.8 score on a scale
Standard Deviation 0.4
|
5.8 score on a scale
Standard Deviation 0.4
|
|
Functional Independence Measure (FIM) Scores
Wheelchair (Week 8)
|
5.9 score on a scale
Standard Deviation 0.4
|
6.1 score on a scale
Standard Deviation 0.0
|
|
Functional Independence Measure (FIM) Scores
Bed/Chair/Wheelchair Mobility (Preop)
|
4.9 score on a scale
Standard Deviation 1.0
|
4.3 score on a scale
Standard Deviation 0.7
|
|
Functional Independence Measure (FIM) Scores
Bed/Chair/Wheelchair Mobility (Week 4)
|
5.9 score on a scale
Standard Deviation 0.4
|
5.7 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, and 12Population: Subjects who were enrolled in the study and for whom this data was collected.
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.
Outcome measures
| Measure |
Peripheral Nerve Stimulation (PNS)
n=4 Participants
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.
|
Control
n=8 Participants
Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
|
|---|---|---|
|
Pain Interference
Baseline
|
2.7 score on a scale
Standard Deviation 3.1
|
3.7 score on a scale
Standard Deviation 2.3
|
|
Pain Interference
Week 4
|
2 score on a scale
Standard Deviation 2.6
|
1.1 score on a scale
Standard Deviation 1.5
|
|
Pain Interference
Week 8
|
1.0 score on a scale
Standard Deviation 1.1
|
1.0 score on a scale
Standard Deviation 2.1
|
|
Pain Interference
Week 12
|
0.2 score on a scale
Standard Deviation 0.4
|
0.8 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Weeks 4, 8, and 12Population: Subjects who were enrolled in the study and for whom this data was collected.
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.
Outcome measures
| Measure |
Peripheral Nerve Stimulation (PNS)
n=7 Participants
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.
|
Control
n=8 Participants
Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
|
|---|---|---|
|
Patient Global Impression of Change (PGIC)
Week 4
|
4.3 score on a scale
Standard Deviation 2.6
|
3.9 score on a scale
Standard Deviation 2.2
|
|
Patient Global Impression of Change (PGIC)
Week 8
|
4.1 score on a scale
Standard Deviation 2.7
|
5.1 score on a scale
Standard Deviation 2.1
|
|
Patient Global Impression of Change (PGIC)
Week 12
|
3.8 score on a scale
Standard Deviation 2.2
|
2.4 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, and 12Population: Subjects who were enrolled in the study and for whom this data was collected.
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.
Outcome measures
| Measure |
Peripheral Nerve Stimulation (PNS)
n=8 Participants
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.
|
Control
n=8 Participants
Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
|
|---|---|---|
|
Pain Catastrophizing Scale (PCS)
Baseline
|
20.3 score on a scale
Standard Deviation 7.7
|
12.3 score on a scale
Standard Deviation 9.2
|
|
Pain Catastrophizing Scale (PCS)
Week 4
|
10.3 score on a scale
Standard Deviation 7.2
|
8 score on a scale
Standard Deviation 10.4
|
|
Pain Catastrophizing Scale (PCS)
Week 8
|
4.1 score on a scale
Standard Deviation 10.1
|
4.6 score on a scale
Standard Deviation 7.4
|
|
Pain Catastrophizing Scale (PCS)
Week 12
|
17 score on a scale
Standard Deviation 21.8
|
9.8 score on a scale
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: Weeks 4, Week 8, and Week 12Population: Subjects who were enrolled in the study and for whom this data was collected.
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.
Outcome measures
| Measure |
Peripheral Nerve Stimulation (PNS)
n=7 Participants
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.
|
Control
n=8 Participants
Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
|
|---|---|---|
|
Pain Disability Index (PDI)
Week 4
|
22.2 score on a scale
Standard Deviation 26.3
|
6 score on a scale
Standard Deviation 11.3
|
|
Pain Disability Index (PDI)
Week 8
|
15.9 score on a scale
Standard Deviation 26.3
|
6 score on a scale
Standard Deviation 12.9
|
|
Pain Disability Index (PDI)
Week 12
|
44.7 score on a scale
Standard Deviation 38.8
|
7.7 score on a scale
Standard Deviation 18.3
|
SECONDARY outcome
Timeframe: 30 days from hospital dischargePercent of Group that was readmitted to the hospital within 30 days following hospital discharge.
Outcome measures
| Measure |
Peripheral Nerve Stimulation (PNS)
n=8 Participants
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.
|
Control
n=8 Participants
Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
|
|---|---|---|
|
30-day Readmission Rate
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Number of days from surgery to dischargeHospital LOS was calculated from day of surgery to day of discharge from inpatient hospital ward to rehabilitation facility.
Outcome measures
| Measure |
Peripheral Nerve Stimulation (PNS)
n=8 Participants
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.
|
Control
n=8 Participants
Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
|
|---|---|---|
|
Hospital Length of Stay (LOS)
|
7 days
Standard Deviation 1.6
|
6 days
Standard Deviation 3.3
|
Adverse Events
Peripheral Nerve Stimulation (PNS)
Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Peripheral Nerve Stimulation (PNS)
n=8 participants at risk
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.
|
Control
n=8 participants at risk
Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
|
|---|---|---|
|
Surgical and medical procedures
PNS Lead Reimplantation
|
25.0%
2/8 • Number of events 2 • Week 4 and Week 8, Month 3, Month 6, and Month 12
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.
|
—
0/0 • Week 4 and Week 8, Month 3, Month 6, and Month 12
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.
|
Additional Information
Dr. Denise Lester
Central Virginia Veterans Affairs Health Care System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place