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Completed

NCT Number: NCT03484429

Postoperative Peripheral Nerve Stimulation for Management of Post-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.

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Key information

Conditions

Phantom Limb Pain Acute Pain Amputation Chronic Pain Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nerve Sheath Neoplasms Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Neuroma Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Phantom Limb Postoperative Complications Postoperative Pain Residual Limbs Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

About this 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peripheral Nerve Stimulation

Device

Up to 60 days of peripheral nerve stimulation

Standard Medical Therapy

Other

Medications, physical therapy, or other pain treatments

Primary outcomes

  1. 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.

  2. 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.

  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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Hunter Holmes Mcguire Veteran Affairs Medical Center

Fed

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 30, 2018
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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