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Trial record 28 of 55 for:    Recruiting, Not yet recruiting, Available Studies | "Neuroma"

Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain

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ClinicalTrials.gov Identifier: NCT03484429
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Hunter Holmes Mcguire Veteran Affairs Medical Center

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
Phantom Limb Pain Postoperative Pain Neuroma Acute Pain Chronic Pain Residual Limbs Amputation Device: Peripheral nerve stimulation Other: Standard Medical Therapy Not Applicable

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  (Clinical Trial)
Estimated 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 : December 1, 2017
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2019

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




Primary Outcome Measures :
  1. Change from Baseline in Residual Limb Pain [ Time Frame: 2 months, 3 months, 6 months, and 12 months ]
    Assessed by Brief Pain Inventory questionnaire

  2. Change from Baseline in Phantom Limb Pain [ Time Frame: 2 months, 3 months, 6 months, and 12 months ]
    Assessed by Brief Pain Inventory questionnaire


Secondary Outcome Measures :
  1. Change from Baseline in Interference of daily activities due to pain [ Time Frame: 2 months, 3 months, 6 months, and 12 months ]
    Assessed by Brief Pain Inventory questionnaire

  2. Change from Baseline in opioid pain medication use [ Time Frame: 2 months, 3 months, 6 months, and 12 months ]
    Assessed by weekly pill count

  3. Change from Baseline in Patient Global Impression of Change score [ Time Frame: 2 months, 3 months, 6 months, and 12 months ]
    Assessed by questionnaire. Rates perception of change in activity limitations, symptoms, emotions, and overall quality of life in relation to pain since beginning treatment. The scale ranges from 0 defined as "No change" to 7 defined as "A great deal better, and a considerable improvement that has made all the difference."

  4. Change from Baseline in Functional Independence Measure score [ Time Frame: 2 months ]
    Uniform system of measurement for disability based on the International Classification of Impairment, Disabilities and Handicaps. Assessed by physical therapist evaluation.

  5. Change from Baseline in Pain Disability Index score [ Time Frame: 2 months, 3 months, 6 months, and 12 months ]
    Instrument which measures subjects' disruption in various aspects of life secondary to chronic pain, including family/home responsibilities, recreation, social activity, occupation, sexual behavior, self-care, and life-support activities. Each category is rated on an 11-point scale from "0" to "10" with "0" defined as "No Disability" and "10" defined as "Worst Disability."

  6. Change from Baseline in Pain Catastrophizing Scale [ Time Frame: 2 months, 3 months, 6 months, and 12 months ]
    13-question instrument to assess rumination (4 questions), magnification (3 questions), and helplessness (6 questions). The survey asks participants to think back on painful experiences in the past and reflect on how often they had specific thoughts or feelings. Each question is scored on a 0-4 scale with 0 = "not at all" and 4 = "all the time". Higher scores indicate a greater tendency towards catastrophizing pain.



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484429


Contacts
Contact: Denise Lester, MD 8046755188 Denise.Lester@va.gov
Contact: Thomas Phan, MD 8587364782 Thomas.Phan@vcuhealth.org

Locations
United States, Virginia
Hunter Holmes McGuire VA Medical Center Recruiting
Richmond, Virginia, United States, 23249
Contact: IRB Coordinator    804-675-5677    Shelkieta.Kelley@va.gov   
Sponsors and Collaborators
Hunter Holmes Mcguire Veteran Affairs Medical Center
Investigators
Principal Investigator: Denise Lester, MD Hunter Holmes McGuire VA Medical Center

Responsible Party: Hunter Holmes Mcguire Veteran Affairs Medical Center
ClinicalTrials.gov Identifier: NCT03484429     History of Changes
Other Study ID Numbers: 2343
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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
Pain, Postoperative
Chronic Pain
Acute Pain
Phantom Limb
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Perceptual Disorders
Neurobehavioral Manifestations
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms