An interventional study of Peripheral nerve stimulation and Standard Medical Therapy in Phantom Limb Pain, Postoperative Pain and Neuroma, sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-21.
Sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center · Not applicable, Interventional, and Treatment
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.
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
163 studies on the registry are indexed under Phantom Limb; 35 are open to participants now.
This study's enrollment of 16 is below the median of 30 across 125 interventional studies indexed under Phantom Limb.
Browse Phantom Limb studies →Hunter Holmes Mcguire Veteran Affairs Medical Center is the lead sponsor of 31 studies on the registry; 1 is open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Standard medical therapy only
Other: Standard Medical Therapy
Up to 60 days of peripheral nerve stimulation
Medications, physical therapy, or other pain treatments
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Weeks 1-4, Weeks 5-8, and Month 3
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.
Time frame: Preop, Hospital Discharge, Weeks 1-4, Weeks 5-8, Week 12
Average Oral Morphine Equivalents (OME)
Opioid consumption (daily OME) over time was collected for all subjects.
Time frame: Preoperative, Hospital discharge, Weeks 1-4, Weeks 5-8, and Week 12
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.
Time frame: Preoperative, Week 4, and Week 8
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.
Time frame: Baseline, Weeks 4, 8, and 12
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.
Time frame: Weeks 4, 8, and 12
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.
Time frame: Baseline, Weeks 4, 8, and 12
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.
Time frame: Weeks 4, Week 8, and Week 12
30-day Readmission Rate
Percent of Group that was readmitted to the hospital within 30 days following hospital discharge.
Time frame: 30 days from hospital discharge
Hospital Length of Stay (LOS)
Hospital LOS was calculated from day of surgery to day of discharge from inpatient hospital ward to rehabilitation facility.
Time frame: Number of days from surgery to discharge
| Milestone | Peripheral Nerve Stimulation (PNS) | Standard Medical Therapy (SMT) |
|---|---|---|
| Started | 8 | 8 |
| Postamputation week 1-4 | 8 | 8 |
| Postamputation week 5-8 | 5 | 8 |
| Postamputation month 3 | 5 | 7 |
| Completed | 5 | 8 |
| Not completed | 3 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Adverse event | 2 | 0 |
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.
| score on a scale | Peripheral Nerve Stimulation (PNS) | Control |
|---|---|---|
| Baseline | 4.1 ± 3.2 | 3.1 ± 2.7 |
| Weeks 1-4 | 2.2 ± 2.4 | 3.0 ± 1.7 |
| Weeks 5-8 | 1.0 ± 1.2 | 2.2 ± 2.2 |
| Month 3 | 1.0 ± 1.2 | 1.3 ± 2.2 |
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.
| score on a scale | Peripheral Nerve Stimulation (PNS) | Control |
|---|---|---|
| Baseline | 7.1 ± 2.2 | 4.4 ± 1.4 |
| Weeks 1-4 | 3.6 ± 2.5 | 2.2 ± 1.6 |
| Weeks 5-8 | 1 ± 1 | 2.1 ± 2 |
| Month 3 | 0 ± 0 | 1.1 ± 1.9 |
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.
| score on a scale | Peripheral Nerve Stimulation (PNS) | Control |
|---|---|---|
| Baseline | 6.5 ± 4.4 | 5.9 ± 4.0 |
| Weeks 1-4 | 3.1 ± 3.1 | 5.4 ± 2.6 |
| Weeks 5-8 | 2.2 ± 1.6 | 3.6 ± 3.3 |
| Month 3 | 2.2 ± 2.7 | 2.0 ± 3.2 |
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.
| score on a scale | Peripheral Nerve Stimulation (PNS) | Control |
|---|---|---|
| Baseline | 8.3 ± 1.9 | 7.8 ± 1.9 |
| Weeks 1-4 | 5.1 ± 2.6 | 4.1 ± 2.5 |
| Weeks 5-8 | 1.7 ± 1.5 | 3.2 ± 2.7 |
| Month 3 | 0 ± 0 | 1.9 ± 2.9 |
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.
| score on a scale | Peripheral Nerve Stimulation (PNS) | Control |
|---|---|---|
| Baseline | 1.4 ± 2.1 | 1.3 ± 1.6 |
| Weeks 1-4 | 0.8 ± 1.1 | 1.4 ± 1.4 |
| Weeks 5-8 | 0.6 ± 1.0 | 1.1 ± 0.9 |
| Month 3 | 0.4 ± 0.7 | 1.0 ± 1.4 |
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.
| score on a scale | Peripheral Nerve Stimulation (PNS) | Control |
|---|---|---|
| Baseline | 4.1 ± 2.6 | 1.5 ± 1.5 |
| Weeks 1-4 | 1.7 ± 1.4 | 1.0 ± 0.8 |
| Weeks 5-8 | 0.4 ± 0.7 | 1.0 ± 0.9 |
| Month 3 | 0.0 ± 0.0 | 0.4 ± 1.1 |
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.
| Participants | Peripheral Nerve Stimulation (PNS) | Control |
|---|---|---|
| Baseline | 3 | 2 |
| Hospital Discharge | 6 | 7 |
| Weeks 1-4 | 3 | 5 |
| Weeks 5-8 | 1 | 4 |
| Week 12 | 1 | 3 |
Opioid consumption (daily OME) over time was collected for all subjects.
| oral morphine equivalents (mg) | Peripheral Nerve Stimulation (PNS) | Control |
|---|---|---|
| Preop | 36.1 ± 60.5 | 7.2 ± 13.3 |
| Hospital Discharge | 44.1 ± 57.2 | 36.1 ± 30.4 |
| Weeks 1-4 | 23.4 ± 47.7 | 16.6 ± 30.0 |
| Weeks 5-8 | 13.5 ± 24.9 | 20.3 ± 31.0 |
| Week 12 | 13.5 ± 23.9 | 10.7 ± 20.7 |
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.
| score on a scale | Peripheral Nerve Stimulation (PNS) | Control |
|---|---|---|
| Walk (Preop) | 1 ± 0 | 1 ± 0 |
| Walk (Week 4) | 1 ± 0 | 1.2 ± 0.4 |
| Walk (Week 8) | 1.7 ± 1.5 | 1.3 ± 0.8 |
| Wheelchair (Preop) | 4.8 ± 1.6 | 5.4 ± 0.7 |
| Wheelchair (Week 4) | 5.8 ± 0.4 | 5.8 ± 0.4 |
| Wheelchair (Week 8) | 5.9 ± 0.4 | 6.1 ± 0.0 |
| Tub/Shower Transfer (Preop) | 4.1 ± 1.6 | 4.1 ± 1.1 |
| Tub/Shower Transfer (Week 4) | 5.8 ± 0.4 | 5.4 ± 1.5 |
| Tub/Shower Transfer (Week 8) | 5.7 ± 0.5 | 5.7 ± 0.5 |
| Toilet Transfer (Preop) | 4.6 ± 0.9 | 3.9 ± 1.4 |
| Toilet Transfer (Week 4) | 5.8 ± 0.4 | 5.0 ± 1.7 |
| Toilet Transfer (Week 8) | 5.7 ± 0.5 | 5.7 ± 0.5 |
| Bed/Chair/Wheelchair Mobility (Preop) | 4.9 ± 1.0 | 4.3 ± 0.7 |
| Bed/Chair/Wheelchair Mobility (Week 4) | 5.9 ± 0.4 | 5.7 ± 0.9 |
| Bed/Chair/Wheelchair Mobility (Week 8) | 5.7 ± 0.5 | 6.0 ± 0.0 |
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.
| score on a scale | Peripheral Nerve Stimulation (PNS) | Control |
|---|---|---|
| Baseline | 2.7 ± 3.1 | 3.7 ± 2.3 |
| Week 4 | 2 ± 2.6 | 1.1 ± 1.5 |
| Week 8 | 1.0 ± 1.1 | 1.0 ± 2.1 |
| Week 12 | 0.2 ± 0.4 | 0.8 ± 1.2 |
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.
| score on a scale | Peripheral Nerve Stimulation (PNS) | Control |
|---|---|---|
| Week 4 | 4.3 ± 2.6 | 3.9 ± 2.2 |
| Week 8 | 4.1 ± 2.7 | 5.1 ± 2.1 |
| Week 12 | 3.8 ± 2.2 | 2.4 ± 1.5 |
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.
| score on a scale | Peripheral Nerve Stimulation (PNS) | Control |
|---|---|---|
| Baseline | 20.3 ± 7.7 | 12.3 ± 9.2 |
| Week 4 | 10.3 ± 7.2 | 8 ± 10.4 |
| Week 8 | 4.1 ± 10.1 | 4.6 ± 7.4 |
| Week 12 | 17 ± 21.8 | 9.8 ± 14.3 |
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.
| score on a scale | Peripheral Nerve Stimulation (PNS) | Control |
|---|---|---|
| Week 4 | 22.2 ± 26.3 | 6 ± 11.3 |
| Week 8 | 15.9 ± 26.3 | 6 ± 12.9 |
| Week 12 | 44.7 ± 38.8 | 7.7 ± 18.3 |
Percent of Group that was readmitted to the hospital within 30 days following hospital discharge.
| Participants | Peripheral Nerve Stimulation (PNS) | Control |
|---|---|---|
| 30-day Readmission Rate | 0 | 2 |
Hospital LOS was calculated from day of surgery to day of discharge from inpatient hospital ward to rehabilitation facility.
| days | Peripheral Nerve Stimulation (PNS) | Control |
|---|---|---|
| Hospital Length of Stay (LOS) | 7 ± 1.6 | 6 ± 3.3 |
Collected over Week 4 and Week 8, Month 3, Month 6, and Month 12. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Peripheral Nerve Stimulation (PNS) | 1/8 (12.5%) | 0/8 (0%) | 2/8 (25%) |
| Control | 0/8 (0%) | 0/8 (0%) | — |
| Event | Peripheral Nerve Stimulation (PNS) | Control |
|---|---|---|
| PNS Lead ReimplantationSurgical and medical procedures | 2/8 | — |
| Age, Categorical(Participants) | Peripheral Nerve Stimulation (PNS) | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 1 | 3 |
| >=65 years | 6 | 7 | 13 |
| Sex: Female, Male(Participants) | Peripheral Nerve Stimulation (PNS) | Control | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 7 | 8 | 15 |
| Race and Ethnicity Not Collected(Participants) | Peripheral Nerve Stimulation (PNS) | Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Peripheral Nerve Stimulation (PNS) | Control | Total |
|---|---|---|---|
| United States | 8 | 8 | 16 |
| Perineural Catheter Infusion(Days) | Peripheral Nerve Stimulation (PNS) | Control | Total |
|---|---|---|---|
| Mean | 6 ± 1 | 5.5 ± 2.5 | 5.75 ± 2.5 |
| Taking Opioids Preoperatively(Participants) | Peripheral Nerve Stimulation (PNS) | Control | Total |
|---|---|---|---|
| Count of participants | 3 | 2 | 5 |
| Level of Amputation(Participants) | Peripheral Nerve Stimulation (PNS) | Control | Total |
|---|---|---|---|
| Above Knee | 5 | 4 | 9 |
| Below Knee | 3 | 4 | 7 |
| Indication for Surgery(Participants) | Peripheral Nerve Stimulation (PNS) | Control | Total |
|---|---|---|---|
| Peripheral Vascular Disease (PVD) | 3 | 4 | 7 |
| Peripheral Arterial Disease (PAD) | 2 | 1 | 3 |
| Pain | 2 | 0 | 2 |
| Diabetes (DM) | 1 | 3 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Dec 2017 to primary completion in Apr 2021, 40 months.
Results were first posted in Jul 2021, 3 months after primary completion.
Of 61 non-industry interventional studies with no phase under Phantom Limb, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 40 months is above that.
Counting every sponsor, half of 64 studies reached it within 34 months; a quarter within 13 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Hunter Holmes Mcguire Veteran Affairs Medical Center