Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain

NCT03484429 | Completed Results DMC FDA Device

• 1 other identifier: 2343
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Phantom Limb Pain; Postoperative Pain; Neuroma; Acute Pain; Chronic Pain; Residual Limbs; Amputation

Keywords

Neurostimulation; Peripheral nerve stimulation

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Baseline, Weeks 1-4, Weeks 5-8, and Month 3

Secondary Outcomes (9)

• Number Taking Opioids

  Preop, Hospital Discharge, Weeks 1-4, Weeks 5-8, Week 12

• Average Oral Morphine Equivalents (OME)

  Preoperative, Hospital discharge, Weeks 1-4, Weeks 5-8, and Week 12

• Functional Independence Measure (FIM) Scores

  Preoperative, Week 4, and Week 8

• Pain Interference

  Baseline, Weeks 4, 8, and 12

• Patient Global Impression of Change (PGIC)

  Weeks 4, 8, and 12

Study Arms (2)

Group 1

EXPERIMENTAL

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

Device: Peripheral nerve stimulation; Other: Standard Medical Therapy

Group 2

ACTIVE COMPARATOR

Standard medical therapy only

Other: Standard Medical Therapy

Interventions

Peripheral nerve stimulation DEVICE

Up to 60 days of peripheral nerve stimulation

Group 1

Standard Medical Therapy OTHER

Medications, physical therapy, or other pain treatments

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nontraumatic transfemoral (above-the-knee) or transtibial (below-the-knee) amputation
• Presence of postamputation pain rated at least 4 or more

You may not qualify if:

• 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

Sponsors & Collaborators

• Hunter Holmes Mcguire Veteran Affairs Medical Center: lead

Study Sites (1)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

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MeSH Terms

Conditions

Phantom Limb; Pain, Postoperative; Neuroma; Acute Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms

Limitations and 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.

Results Point of Contact

• Title: Dr. Denise Lester
• Organization: Central Virginia Veterans Affairs Health Care System

denise.lester@va.gov

804-675-5000

Study Officials

• Denise Lester, MD

  Hunter Holmes McGuire VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: March 30, 2018
• Study Start: December 1, 2017
• Primary Completion: April 17, 2021
• Study Completion: April 17, 2021
• Last Updated: July 21, 2021
• Results First Posted: July 21, 2021

Record last verified: 2021-06

Locations

US (1)