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Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain

Sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT03484429
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
40.5
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Peripheral nerve stimulation
  • Other: Standard Medical Therapy
 N/A

Detailed Description

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 Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Postoperative Percutaneous Peripheral Nerve Stimulation on Acute and Chronic Amputation Pain
Actual Study Start Date :
Dec 1, 2017
Actual Primary Completion Date :
Apr 17, 2021
Actual Study Completion Date :
Apr 17, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

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

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

Other: Standard Medical Therapy
Medications, physical therapy, or other pain treatments
Active Comparator: Group 2

Standard medical therapy only

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

Outcome Measures

Primary Outcome Measures

  1. Average Phantom Limb Pain (PLP) Score [Baseline, Weeks 1-4, Weeks 5-8, and Month 3.]

    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.

  2. Average Residual Limb Pain (RLP) Score [Baseline, Weeks 1-4, Weeks 5-8, and Month 3]

    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.

  3. Worst Phantom Limb Pain (PLP) Score [Baseline, Weeks 1-4, 5-8, and Month 3]

    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.

  4. Worst Residual Limb Pain (RLP) Score [Baseline, Weeks 1-4, Weeks 5-8, and Month 3]

    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.

  5. Best Phantom Limb Pain (PLP) Score [Baseline, Weeks 1-4, Weeks 5-8, and Month 3]

    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.

  6. Best Residual Limb Pain (RLP) Score [Baseline, Weeks 1-4, Weeks 5-8, and Month 3]

    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.

Secondary Outcome Measures

  1. Number Taking Opioids [Preop, Hospital Discharge, Weeks 1-4, Weeks 5-8, Week 12]

    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.

  2. Average Oral Morphine Equivalents (OME) [Preoperative, Hospital discharge, Weeks 1-4, Weeks 5-8, and Week 12]

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

  3. Functional Independence Measure (FIM) Scores [Preoperative, Week 4, and Week 8]

    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.

  4. Pain Interference [Baseline, Weeks 4, 8, and 12]

    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.

  5. Patient Global Impression of Change (PGIC) [Weeks 4, 8, and 12]

    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.

  6. Pain Catastrophizing Scale (PCS) [Baseline, Weeks 4, 8, and 12]

    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.

  7. Pain Disability Index (PDI) [Weeks 4, Week 8, and Week 12]

    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.

  8. 30-day Readmission Rate [30 days from hospital discharge]

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

  9. Hospital Length of Stay (LOS) [Number of days from surgery to discharge]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Nontraumatic transfemoral (above-the-knee) or transtibial (below-the-knee) amputation

  • Presence of postamputation pain rated at least 4 or more

Exclusion Criteria:

  • Beck Depression Inventory score greater than 20

  • Systemic infection

  • Immunocompromised or taking immunosuppressive medications

  • Implanted electronic device

  • Pregnancy

  • Previous allergy to skin contact materials and/or anesthetic agent

  • Altered mental status

  • Inability to provide informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hunter Holmes McGuire VA Medical Center Richmond Virginia United States 23249

Sponsors and Collaborators

  • Hunter Holmes Mcguire Veteran Affairs Medical Center

Investigators

  • Principal Investigator: Denise Lester, MD, Hunter Holmes McGuire VA Medical Center

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Hunter Holmes Mcguire Veteran Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT03484429
Other Study ID Numbers:
  • 2343
First Posted:
Mar 30, 2018
Last Update Posted:
Jul 21, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Hunter Holmes Mcguire Veteran Affairs Medical Center
Neurostimulation
Peripheral nerve stimulation
Additional relevant MeSH terms:
Neuroma
Phantom Limb
Chronic Pain
Acute Pain

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Peripheral Nerve Stimulation (PNS) Standard Medical Therapy (SMT)
Arm/Group Description 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
Period Title: Overall Study
STARTED 8 8
Postamputation Week 1-4 8 8
Postamputation Week 5-8 5 8
Postamputation Month 3 5 7
COMPLETED 5 8
NOT COMPLETED 3 0

Baseline Characteristics

Arm/Group Title Peripheral Nerve Stimulation (PNS) Control Total
Arm/Group Description 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. Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies. Total of all reporting groups
Overall Participants 8 8 16
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
2
25%
1
12.5%
3
18.8%
>=65 years
6
75%
7
87.5%
13
81.3%
Sex: Female, Male (Count of Participants)
Female
1
12.5%
0
0%
1
6.3%
Male
7
87.5%
8
100%
15
93.8%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]
0
0%
Region of Enrollment (participants) [Number]
United States
8
100%
8
100%
16
100%
Perineural Catheter Infusion (Days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Days]
6
(1)
5.5
(2.5)
5.75
(2.5)
Taking Opioids Preoperatively (Count of Participants)
Count of Participants [Participants]
3
37.5%
2
25%
5
31.3%
Level of Amputation (Count of Participants)
Above Knee
5
62.5%
4
50%
9
56.3%
Below Knee
3
37.5%
4
50%
7
43.8%
Indication for Surgery (Count of Participants)
Peripheral Vascular Disease (PVD)
3
37.5%
4
50%
7
43.8%
Peripheral Arterial Disease (PAD)
2
25%
1
12.5%
3
18.8%
Pain
2
25%
0
0%
2
12.5%
Diabetes (DM)
1
12.5%
3
37.5%
4
25%

Outcome Measures

1. Primary Outcome
Title Average Phantom Limb Pain (PLP) Score
Description 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.

Outcome Measure Data

Analysis Population Description
Subjects who completed up to 60 days of peripheral nerve stimulation (PNS) and standard medical therapy (SMT) or (SMT) only.
Arm/Group Title Peripheral Nerve Stimulation (PNS) Control
Arm/Group Description 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. Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
Measure Participants 8 8
Baseline
4.1
(3.2)
3.1
(2.7)
Weeks 1-4
2.2
(2.4)
3.0
(1.7)
Weeks 5-8
1.0
(1.2)
2.2
(2.2)
Month 3
1.0
(1.2)
1.3
(2.2)
2. Primary Outcome
Title Average Residual Limb Pain (RLP) Score
Description 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

Outcome Measure Data

Analysis Population Description
Subjects who completed up to 60 days of peripheral nerve stimulation (PNS) and standard medical therapy (SMT) or (SMT) only.
Arm/Group Title Peripheral Nerve Stimulation (PNS) Control
Arm/Group Description 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. Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
Measure Participants 8 8
Baseline
7.1
(2.2)
4.4
(1.4)
Weeks 1-4
3.6
(2.5)
2.2
(1.6)
Weeks 5-8
1
(1)
2.1
(2)
Month 3
0
(0)
1.1
(1.9)
3. Primary Outcome
Title Worst Phantom Limb Pain (PLP) Score
Description 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

Outcome Measure Data

Analysis Population Description
Subjects who completed up to 60 days of peripheral nerve stimulation (PNS) and standard medical therapy (SMT) or (SMT) only.
Arm/Group Title Peripheral Nerve Stimulation (PNS) Control
Arm/Group Description 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. Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
Measure Participants 8 8
Baseline
6.5
(4.4)
5.9
(4.0)
Weeks 1-4
3.1
(3.1)
5.4
(2.6)
Weeks 5-8
2.2
(1.6)
3.6
(3.3)
Month 3
2.2
(2.7)
2.0
(3.2)
4. Primary Outcome
Title Worst Residual Limb Pain (RLP) Score
Description 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

Outcome Measure Data

Analysis Population Description
Subjects who completed up to 60 days of peripheral nerve stimulation (PNS) and standard medical therapy (SMT) or (SMT) only.
Arm/Group Title Peripheral Nerve Stimulation (PNS) Control
Arm/Group Description 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. Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
Measure Participants 8 8
Baseline
8.3
(1.9)
7.8
(1.9)
Weeks 1-4
5.1
(2.6)
4.1
(2.5)
Weeks 5-8
1.7
(1.5)
3.2
(2.7)
Month 3
0
(0)
1.9
(2.9)
5. Primary Outcome
Title Best Phantom Limb Pain (PLP) Score
Description 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

Outcome Measure Data

Analysis Population Description
Subjects who completed up to 60 days of peripheral nerve stimulation (PNS) and standard medical therapy (SMT) or (SMT) only.
Arm/Group Title Peripheral Nerve Stimulation (PNS) Control
Arm/Group Description 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. Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
Measure Participants 8 8
Baseline
1.4
(2.1)
1.3
(1.6)
Weeks 1-4
0.8
(1.1)
1.4
(1.4)
Weeks 5-8
0.6
(1.0)
1.1
(0.9)
Month 3
0.4
(0.7)
1.0
(1.4)
6. Primary Outcome
Title Best Residual Limb Pain (RLP) Score
Description 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

Outcome Measure Data

Analysis Population Description
Subjects who completed up to 60 days of peripheral nerve stimulation (PNS) and standard medical therapy (SMT) or (SMT) only.
Arm/Group Title Peripheral Nerve Stimulation (PNS) Control
Arm/Group Description 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. Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
Measure Participants 8 8
Baseline
4.1
(2.6)
1.5
(1.5)
Weeks 1-4
1.7
(1.4)
1.0
(0.8)
Weeks 5-8
0.4
(0.7)
1.0
(0.9)
Month 3
0.0
(0.0)
0.4
(1.1)
7. Secondary Outcome
Title Number Taking Opioids
Description 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

Outcome Measure Data

Analysis Population Description
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).
Arm/Group Title Peripheral Nerve Stimulation (PNS) Control
Arm/Group Description 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. Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
Measure Participants 8 8
Baseline
3
37.5%
2
25%
Hospital Discharge
6
75%
7
87.5%
Weeks 1-4
3
37.5%
5
62.5%
Weeks 5-8
1
12.5%
4
50%
Week 12
1
12.5%
3
37.5%
8. Secondary Outcome
Title Average Oral Morphine Equivalents (OME)
Description 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

Outcome Measure Data

Analysis Population Description
All study participants were evaluated.
Arm/Group Title Peripheral Nerve Stimulation (PNS) Control
Arm/Group Description 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. Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
Measure Participants 8 8
Preop
36.1
(60.5)
7.2
(13.3)
Hospital Discharge
44.1
(57.2)
36.1
(30.4)
Weeks 1-4
23.4
(47.7)
16.6
(30.0)
Weeks 5-8
13.5
(24.9)
20.3
(31.0)
Week 12
13.5
(23.9)
10.7
(20.7)
9. Secondary Outcome
Title Functional Independence Measure (FIM) Scores
Description 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

Outcome Measure Data

Analysis Population Description
All qualifying subjects were evaluated.
Arm/Group Title Peripheral Nerve Stimulation (PNS) Control
Arm/Group Description 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. Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
Measure Participants 8 8
Walk (Preop)
1
(0)
1
(0)
Walk (Week 4)
1
(0)
1.2
(0.4)
Walk (Week 8)
1.7
(1.5)
1.3
(0.8)
Wheelchair (Preop)
4.8
(1.6)
5.4
(0.7)
Wheelchair (Week 4)
5.8
(0.4)
5.8
(0.4)
Wheelchair (Week 8)
5.9
(0.4)
6.1
(0.0)
Tub/Shower Transfer (Preop)
4.1
(1.6)
4.1
(1.1)
Tub/Shower Transfer (Week 4)
5.8
(0.4)
5.4
(1.5)
Tub/Shower Transfer (Week 8)
5.7
(0.5)
5.7
(0.5)
Toilet Transfer (Preop)
4.6
(0.9)
3.9
(1.4)
Toilet Transfer (Week 4)
5.8
(0.4)
5.0
(1.7)
Toilet Transfer (Week 8)
5.7
(0.5)
5.7
(0.5)
Bed/Chair/Wheelchair Mobility (Preop)
4.9
(1.0)
4.3
(0.7)
Bed/Chair/Wheelchair Mobility (Week 4)
5.9
(0.4)
5.7
(0.9)
Bed/Chair/Wheelchair Mobility (Week 8)
5.7
(0.5)
6.0
(0.0)
10. Secondary Outcome
Title Pain Interference
Description 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

Outcome Measure Data

Analysis Population Description
Subjects who were enrolled in the study and for whom this data was collected.
Arm/Group Title Peripheral Nerve Stimulation (PNS) Control
Arm/Group Description 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. Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
Measure Participants 4 8
Baseline
2.7
(3.1)
3.7
(2.3)
Week 4
2
(2.6)
1.1
(1.5)
Week 8
1.0
(1.1)
1.0
(2.1)
Week 12
0.2
(0.4)
0.8
(1.2)
11. Secondary Outcome
Title Patient Global Impression of Change (PGIC)
Description 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

Outcome Measure Data

Analysis Population Description
Subjects who were enrolled in the study and for whom this data was collected.
Arm/Group Title Peripheral Nerve Stimulation (PNS) Control
Arm/Group Description 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. Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
Measure Participants 7 8
Week 4
4.3
(2.6)
3.9
(2.2)
Week 8
4.1
(2.7)
5.1
(2.1)
Week 12
3.8
(2.2)
2.4
(1.5)
12. Secondary Outcome
Title Pain Catastrophizing Scale (PCS)
Description 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.
Time Frame Baseline, Weeks 4, 8, and 12

Outcome Measure Data

Analysis Population Description
Subjects who were enrolled in the study and for whom this data was collected.
Arm/Group Title Peripheral Nerve Stimulation (PNS) Control
Arm/Group Description 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. Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
Measure Participants 8 8
Baseline
20.3
(7.7)
12.3
(9.2)
Week 4
10.3
(7.2)
8
(10.4)
Week 8
4.1
(10.1)
4.6
(7.4)
Week 12
17
(21.8)
9.8
(14.3)
13. Secondary Outcome
Title Pain Disability Index (PDI)
Description 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

Outcome Measure Data

Analysis Population Description
Subjects who were enrolled in the study and for whom this data was collected.
Arm/Group Title Peripheral Nerve Stimulation (PNS) Control
Arm/Group Description 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. Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
Measure Participants 7 8
Week 4
22.2
(26.3)
6
(11.3)
Week 8
15.9
(26.3)
6
(12.9)
Week 12
44.7
(38.8)
7.7
(18.3)
14. Secondary Outcome
Title 30-day Readmission Rate
Description Percent of Group that was readmitted to the hospital within 30 days following hospital discharge.
Time Frame 30 days from hospital discharge

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Peripheral Nerve Stimulation (PNS) Control
Arm/Group Description 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. Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
Measure Participants 8 8
Count of Participants [Participants]
0
0%
2
25%
15. Secondary Outcome
Title Hospital Length of Stay (LOS)
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Peripheral Nerve Stimulation (PNS) Control
Arm/Group Description 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. Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
Measure Participants 8 8
Mean (Standard Deviation) [days]
7
(1.6)
6
(3.3)

Adverse Events

Time Frame Week 4 and Week 8, Month 3, Month 6, and Month 12
Adverse Event Reporting Description 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.
Arm/Group Title Peripheral Nerve Stimulation (PNS) Control
Arm/Group Description 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. Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.
All Cause Mortality
Peripheral Nerve Stimulation (PNS) Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/8 (12.5%) 0/8 (0%)
Serious Adverse Events
Peripheral Nerve Stimulation (PNS) Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/8 (0%) 0/8 (0%)
Other (Not Including Serious) Adverse Events
Peripheral Nerve Stimulation (PNS) Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 2/8 (25%) 0/0 (NaN)
Surgical and medical procedures
PNS Lead Reimplantation 2/8 (25%) 2 0/0 (NaN) 2

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Denise Lester
Organization Central Virginia Veterans Affairs Health Care System
Phone 804-675-5000
Email denise.lester@va.gov
Responsible Party:
Hunter Holmes Mcguire Veteran Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT03484429
Other Study ID Numbers:
  • 2343
First Posted:
Mar 30, 2018
Last Update Posted:
Jul 21, 2021
Last Verified:
Jun 1, 2021