Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03484429

Enrollment

Registered

2018-03-30

Start date

2017-12-01

Completion date

2021-04-17

Last updated

2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Neurostimulation, Peripheral nerve stimulation

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.

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

Interventions

DEVICEPeripheral nerve stimulation

Up to 60 days of peripheral nerve stimulation

OTHERStandard Medical Therapy

Medications, physical therapy, or other pain treatments

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Average Phantom Limb Pain (PLP) Score	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.
Average Residual Limb Pain (RLP) Score	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.
Worst Phantom Limb Pain (PLP) Score	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.
Worst Residual Limb Pain (RLP) Score	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.
Best Phantom Limb Pain (PLP) Score	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.
Best Residual Limb Pain (RLP) Score	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

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

Countries

United States

Participant flow

Participants by arm

Arm	Count
Peripheral Nerve Stimulation (PNS) Up to 60 days of PNS starting within 7 days after major lower limb amputation surgery. Subjects also received standard medical therapy (SMT). SMT is defined as pharmacotherapy, physical therapy, or other therapies.	8
Control Subjects received SMT only after major lower limb amputation surgery. SMT is defined as pharmacotherapy, physical therapy, or other therapies.	8
Total	16

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	2	0
Overall Study	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	Peripheral Nerve Stimulation (PNS)	Control	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	6 Participants	7 Participants	13 Participants
Age, Categorical Between 18 and 65 years	2 Participants	1 Participants	3 Participants
Indication for Surgery Diabetes (DM)	1 Participants	3 Participants	4 Participants
Indication for Surgery Pain	2 Participants	0 Participants	2 Participants
Indication for Surgery Peripheral Arterial Disease (PAD)	2 Participants	1 Participants	3 Participants
Indication for Surgery Peripheral Vascular Disease (PVD)	3 Participants	4 Participants	7 Participants
Level of Amputation Above Knee	5 Participants	4 Participants	9 Participants
Level of Amputation Below Knee	3 Participants	4 Participants	7 Participants
Perineural Catheter Infusion	6 Days STANDARD_DEVIATION 1	5.5 Days STANDARD_DEVIATION 2.5	5.75 Days STANDARD_DEVIATION 2.5
Race and Ethnicity Not Collected	—	—	0 Participants
Region of Enrollment United States	8 participants	8 participants	16 participants
Sex: Female, Male Female	1 Participants	0 Participants	1 Participants
Sex: Female, Male Male	7 Participants	8 Participants	15 Participants
Taking Opioids Preoperatively	3 Participants	2 Participants	5 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	1 / 8	0 / 8
other Total, other adverse events	2 / 8	0 / 0
serious Total, serious adverse events	0 / 8	0 / 8

Outcome results

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.

Time frame: Baseline, Weeks 1-4, Weeks 5-8, and Month 3.