21 and older, any sex, with Neuropathic Pain or Amputation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Subjects With ≥50% Reduction in Average Post-Amputation Pain (Residual Limb Pain [RLP] and/or Phantom Limb Pain [PLP])Primary· Baseline and 5 to 8 weeks post-start of treatment (SOT)
All subjects were asked to complete daily diaries to record their average residual limb pain and/or phantom pain intensities during the past 24 hours on each day of a 7-day period using an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average pain scores were calculated across the 7-day period for each region of pain at baseline and across weeks 5 to 8 post-start of treatment. Percent reduction was then calculated for each subject's qualifying region of pain (residual limb and/or phantom limb pain with qualifying average pa
Group
Value
95% CI
Group 1 (Treatment)
6
Group 2 (Control)
3
Number of Subjects That Experienced at Least One Study-Related Adverse EventPrimary· Up to 14 months for each Group 1 subject and up to 18 months for each Group 2 subject (time from baseline to last study visit)
At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition have occurred since their previous visit. If the subject experienced a change that was a study-related adverse event, an Adverse Event Form was completed by the site. The number of subjects that experienced at least one study-related adverse event is reported here.
Question 9 of the Brief Pain Inventory-Short Form (BPI-9) is a 7-part question that assesses the level of interference that subjects experience in their daily lives due to pain. The 7 categories are general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Subjects were asked to rate how much their post-amputation residual and/or phantom limb pains interfere with each aspect on an 11-point numerical scale where 0 represents "Does Not Interfere" and 10 represents "Completely Interferes." The average of these 7 scores was calculated for each
The Pain Disability Index (PDI) is a validated survey measuring the degree to which pain disrupts 7 categories of life activities on a scale from 0 to 10, with higher scores indicating greater disability. The 7 scores were summed for each subject to provide an overall pain disability score ranging from 0 to 70. A score of 0 indicates no disability while a score of 70 signifies that all of the activities in which the individual would normally be involved have been totally disrupted or prevented by pain. To be considered a success, subjects must have a ≥ 10-point reduction in their total PDI sco
Visit 7: 4-weeks Post-SOT
Group
Value
95% CI
Group 1 (Treatment)
10
Group 2 (Control)
9
Visit 11: 8-weeks Post-SOT
Group
Value
95% CI
Group 1 (Treatment)
10
Group 2 (Control)
9
Visit 13: 3-months Post-SOT
Group
Value
95% CI
Group 1 (Treatment)
12
Group 2 (Control)
5
Visit 14: 6-months Post-SOT
Group
Value
95% CI
Group 1 (Treatment)
10
Visit 16: 12-months Post-SOT
Group
Value
95% CI
Group 1 (Treatment)
6
Patient Global Impression of Change (PGIC) SurveySecondary· Visit 7 (4-weeks post-Start of Therapy [SOT]), Visit 11 (8-weeks post-SOT), Visit 13 (3-months post-SOT), Visit 14 (6-months post-SOT), and Visit 16 (12-months post-SOT)
The Patient Global Impression of Change (PGIC) Survey asks subjects to rate their improvement with treatment on a 7-point scale ranging from -3 to 0 to +3, where -3 represents "very much worse," 0 is "no change," and +3 represents "very much improved" as compared to before stimulation treatment. The subjects combine all the components of their experience into one overall score. The mean rank score of each group was calculated for each time frame.
Visit 7: 4-weeks Post-SOT
Group
Value
95% CI
Group 1 (Treatment)
1.8
± 0.73
Group 2 (Control)
1.0
± 1.1
Visit 11: 8-weeks Post-SOT
Group
Value
95% CI
Group 1 (Treatment)
1.5
± 0.66
Group 2 (Control)
0.88
± 1.6
Visit 13: 3-months Post-SOT
Group
Value
95% CI
Group 1 (Treatment)
1.2
± 0.93
Group 2 (Control)
0.75
± 1.2
Visit 14: 6-months Post-SOT
Group
Value
95% CI
Group 1 (Treatment)
1.3
± 1.4
Visit 16: 12-months Post-SOT
Group
Value
95% CI
Group 1 (Treatment)
1.3
± 1.3
Pain Catastrophizing Scale (PCS)Secondary· Visit 1 (Baseline), Visit 7 (4-weeks post-Start of Treatment [SOT]), and Visit 11 (8-weeks post-SOT)
The Pain Catastrophizing Scale (PCS) questionnaire has 13 questions that assess rumination, magnification, and helplessness. Subjects are asked to think back on painful experiences in the past and reflect on how often they had specific thoughts or feelings. Each of the 13 questions is scored on a 5-point scale where 0 represents "not at all," and 4 represents "all the time." The scores from each question were summed for each subject to provide a total PCS score, with a possible range from 0 to 52 with higher scores indicating a greater tendency to catastrophize pain (i.e. a higher score indica
Visit 1: Baseline
Group
Value
95% CI
Group 1 (Treatment)
17.6
± 10.1
Group 2 (Control)
24.1
± 11.6
Visit 7: 4-weeks Post-SOT
Group
Value
95% CI
Group 1 (Treatment)
12.3
± 10.0
Group 2 (Control)
17.2
± 14.3
Visit 11: 8-weeks Post-SOT
Group
Value
95% CI
Group 1 (Treatment)
8.3
± 8.4
Group 2 (Control)
19.2
± 15.4
Pain Medication UsageSecondary· Baseline, 1 to 4 weeks post-start of treatment (SOT), 5 to 8 weeks post-SOT, 3 months post-SOT, 6 months post-SOT, and 12 months post-SOT
Subjects completed 7-day diaries in which they tracked their daily use of analgesic medications. Opioid analgesic usage was converted into a morphine equivalent dosage (MED), which is measured in units of morphine milligram equivalents (MME), for subjects who were using opioid analgesics at baseline. The average MED was calculated for each subject at each time point.
Baseline
Group
Value
95% CI
Group 1 (Treatment)
32.3
± 37.2
Group 2 (Control)
14.4
± 13.7
1 to 4 weeks Post-SOT
Group
Value
95% CI
Group 1 (Treatment)
32.4
± 36.9
Group 2 (Control)
16.3
± 13.0
5 to 8 weeks Post-SOT
Group
Value
95% CI
Group 1 (Treatment)
30.4
± 38.7
Group 2 (Control)
12.4
± 10.4
3-months Post-SOT
Group
Value
95% CI
Group 1 (Treatment)
30.7
± 38.9
Group 2 (Control)
9.0
± 12.7
6-months Post-SOT
Group
Value
95% CI
Group 1 (Treatment)
21.1
± 21.5
12-months Post-SOT
Group
Value
95% CI
Group 1 (Treatment)
45.0
± 0.0
Number of Subjects With ≥ 50% Reduction in Average Post-Amputation Pain (Residual Limb Pain [RLP] and/or Phantom Limb Pain [PLP]) 1 to 4 Weeks After Start of TreatmentSecondary· Baseline and 1 to 4 weeks post-start of treatment (SOT)
All subjects were asked to complete daily diaries to record their average residual limb pain and/or phantom pain intensities during the past 24 hours on each day of a 7-day period using an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average pain scores were calculated across the 7-day period for each region of pain at baseline and across weeks 1 to 4 post-start of treatment (i.e., the first half of the 8-week treatment period). Percent reduction was then calculated for each subject's qualifying region of pain (residual li
Group
Value
95% CI
Group 1 (Treatment)
3
Group 2 (Control)
3
Number of Subjects With ≥ 50% Reduction in Average Residual Limb Pain (RLP) 5 to 8 Weeks After Start of TreatmentSecondary· Baseline and 5 to 8 weeks post-start of treatment (SOT)
All subjects were asked to complete daily diaries to record their average residual limb pain and/or phantom pain intensities during the past 24 hours on each day of a 7-day period using an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average residual limb pain scores were calculated across the 7-day period at baseline and for weeks 5 to 8 post-start of treatment (for subjects with qualifying residual limb average pain intensity at baseline). Percent reduction from baseline was then calculated, and the number of subjects th
Group
Value
95% CI
Group 1 (Treatment)
5
Group 2 (Control)
3
Number of Subjects With ≥ 50% Reduction in Average Phantom Limb Pain (PLP) 5 to 8 Weeks After Start of TreatmentSecondary· Baseline and 5 to 8 weeks post-start of treatment (SOT)
All subjects were asked to complete daily diaries to record their average residual limb pain and/or phantom pain intensities during the past 24 hours on each day of a 7-day period using an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average phantom limb pain scores were calculated across the 7-day period at baseline and for weeks 5 to 8 post-start of treatment (for subjects with qualifying phantom limb average pain intensity at baseline). Percent reduction from baseline was then calculated, and the number of subjects that
Group
Value
95% CI
Group 1 (Treatment)
7
Group 2 (Control)
3
Durability of Treatment Effect on Average Post-Amputation Pain Intensity (Residual Limb Pain [RLP] and/or Phantom Limb Pain [PLP])Secondary· Baseline, 3-months post-Start of Treatment (SOT), 6-months post-SOT, and 12-months post-SOT
All subjects were asked to complete daily diaries to record their average residual limb pain and/or phantom limb pain intensities during the past 24 hours on each day of a 7-day period using an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average pain scores were calculated across the 7-day period for each region of pain at baseline and at 3, 6, and 12 months post-start of treatment. Percent reduction was then calculated for each subject's qualifying region of pain (residual limb and/or phantom limb pain with qualifying av
3-months Post-SOT
Group
Value
95% CI
Group 1 (Treatment)
4
Group 2 (Control)
3
6-months Post-SOT
Group
Value
95% CI
Group 1 (Treatment)
4
Group 2 (Control)
0
12-months Post-SOT
Group
Value
95% CI
Group 1 (Treatment)
3
Group 2 (Control)
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Each participant enrolled was assessed for adverse events from the time of informed consent through their final study visit. For subjects in Group 1, the total assessment period was approximately 14 months for each participant. Each Group 2 subject that did not crossover to receive stimulation treatment was assessed for approximately 5 months. Group 2 subjects that crossed over to receive treatment were each assessed for approximately 18 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to determine if pain can be relieved by delivering small amounts of electricity (called "electrical stimulation") to the nerves in an individual's amputated leg.This study will involve the use of a Peripheral Nerve Stimulation (PNS) System that is made by SPR Therapeutics (the sponsor of the study). The PNS System was cleared by the FDA for up to 60 days of use for the management of chronic pain, including extremity (leg) pain.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Other trials of SPRINT Peripheral Nerve Stimulation (PNS) System
Trials testing the same drug.
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· NA
· completed
NCT03179202 — Electrical Stimulation for the Treatment of Back Pain Using Peripheral Nerve Stimulation (PNS)
· NA
· completed
NCT02468934 — Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Using the SPRINT System
· NA
· completed
Other recruiting trials for Neuropathic Pain
Currently open trials in the same condition.
NCT07493213 — USG-Guided Shoulder Injections in Frozen Shoulder
· NA
· recruiting
NCT07493226 — Efficacy of Chemically Distinct Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Pain Phenotypes in Adhesive Capsulitis
· NA
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by SPR Therapeutics, Inc.
Last refreshed: 29 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03783689.