Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain

June 30, 2021 updated by: Hunter Holmes Mcguire Veteran Affairs Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Hunter Holmes McGuire VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Phantom Limb Pain (PLP) Score
Time Frame: 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.
Baseline, Weeks 1-4, Weeks 5-8, and Month 3.
Average Residual Limb Pain (RLP) Score
Time Frame: 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.
Baseline, Weeks 1-4, Weeks 5-8, and Month 3
Worst Phantom Limb Pain (PLP) Score
Time Frame: 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.
Baseline, Weeks 1-4, 5-8, and Month 3
Worst Residual Limb Pain (RLP) Score
Time Frame: 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.
Baseline, Weeks 1-4, Weeks 5-8, and Month 3
Best Phantom Limb Pain (PLP) Score
Time Frame: 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.
Baseline, Weeks 1-4, Weeks 5-8, and Month 3
Best Residual Limb Pain (RLP) Score
Time Frame: 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.
Baseline, Weeks 1-4, Weeks 5-8, and Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number Taking Opioids
Time Frame: 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.
Preop, Hospital Discharge, Weeks 1-4, Weeks 5-8, Week 12
Average Oral Morphine Equivalents (OME)
Time Frame: Preoperative, Hospital discharge, Weeks 1-4, Weeks 5-8, and Week 12
Opioid consumption (daily OME) over time was collected for all subjects.
Preoperative, Hospital discharge, Weeks 1-4, Weeks 5-8, and Week 12
Functional Independence Measure (FIM) Scores
Time Frame: 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.
Preoperative, Week 4, and Week 8
Pain Interference
Time Frame: 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.
Baseline, Weeks 4, 8, and 12
Patient Global Impression of Change (PGIC)
Time Frame: 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.
Weeks 4, 8, and 12
Pain Catastrophizing Scale (PCS)
Time Frame: 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.
Baseline, Weeks 4, 8, and 12
Pain Disability Index (PDI)
Time Frame: 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.
Weeks 4, Week 8, and Week 12
30-day Readmission Rate
Time Frame: 30 days from hospital discharge
Percent of Group that was readmitted to the hospital within 30 days following hospital discharge.
30 days from hospital discharge
Hospital Length of Stay (LOS)
Time Frame: 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.
Number of days from surgery to discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hunter Holmes Mcguire Veteran Affairs Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

April 17, 2021

Study Completion (Actual)

April 17, 2021

Study Registration Dates

First Submitted

February 7, 2018

First Submitted That Met QC Criteria

March 29, 2018

First Posted (Actual)

March 30, 2018

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

June 30, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2343

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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