Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03484429
• Other study ID #: 2343
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: April 17, 2021

Study information

• Verified date: June 2021
• Source: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 17, 2021
• Est. primary completion date: April 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

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

Locations

Country	Name	City	State
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Hunter Holmes Mcguire Veteran Affairs Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

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