Electrical Stimulation for the Treatment of Post-Amputation Pain Using the SPRINT System

NCT01996254 | Completed Results

• 1 other identifier: 0123-CSP-000
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively reduce post-amputation pain. This study involves a device called the SPRINT System. The SPRINT System delivers mild electrical stimulation to nerves in the residual limb. The SPRINT System includes a small wire (called a "lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).

Conditions

Post-Amputation Pain; Phantom Limb Pain; Residual Limb Pain

Keywords

electrical stimulation; neurostimulation; neuromodulation; post-amputation pain; phantom limb pain; residual limb pain; neuropathic pain; amputee pain

Outcome Measures

Primary Outcomes (2)

• Proportion of Group 1 (Treatment) and Group 2 (Control) Subjects That Achieved ≥ 50% Reduction in All Qualifying Areas of Pain in the First 4 Weeks of Treatment

  Subjects completed daily diaries to record their average daily pain intensity scores for each qualifying region of pain (phantom limb pain and/or residual limb pain). These pain intensity questions were excerpted from the Brief Pain Inventory - Short Form Question 5 (BPI-5). The BPI-5 is an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." Post-amputation pain intensity scores were determined for each subject by taking the mean of the daily average pain intensity scores from their diaries at Baseline compared to the mean score for the same region(s) of pain reported over 4 weeks after the Start of Treatment (i.e., the average of all diary scores during this period). Subjects that achieved ≥ 50% reduction in their qualifying area(s) of pain were considered successful. Missing diary data were replaced using 1-week BPI-5 recall; if recall scores were unavailable, baseline values were imputed.

  Baseline and Weeks 1-4 Post-Start of Treatment

• Number of Subjects That Experienced at Least One Study-Related Adverse Event in Treatment and Control Groups

  At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition had occurred since their previous visit. If the subject experienced a change that was an 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.

  Each participant enrolled was assessed for adverse events from the time of informed consent through the 12-month follow up visit. The total assessment period was approximately 13 months for each participant.

Secondary Outcomes (8)

• Number of Group 1 (Treatment) Subjects That Experienced ≥ 50% Reduction in All Qualifying Areas of Pain During Weeks 5-8 Compared to Group 2 (Control) Subjects During Weeks 1-4

  Baseline and Weeks 1-8 Post-Start of Treatment

• Proportion of Subjects That Experienced ≥ 50% Reduction in All Qualifying Areas of Pain at Months 3-12 Post-Start of Treatment

  3-months Post-SOT, 4-months Post-SOT, 5-months Post-SOT, 6-months Post-SOT, 7-months Post-SOT, 8-months Post-SOT, 9-months Post-SOT, 10-months Post-SOT, 11-months Post-SOT, and 12-months Post-SOT

• Proportion of Subjects That Experienced ≥50% Reduction in Average Pain Interference With Daily Activities

  Baseline, 4-weeks Post-Start of Treatment (SOT), 8-weeks Post-SOT, 3-months Post-SOT, 4-months Post-SOT, 5-months Post-SOT, 6-months Post-SOT, 7-months Post-SOT, 8-months Post-SOT, 9-months Post-SOT, 10-months Post-SOT, 11-mo Post-SOT, & 12-mo Post-SOT

• Proportion of Group 1 (Treatment) Subjects That Experienced ≥ 10-point Reduction in Pain Disability at Monthly Intervals Post-Start of Treatment Compared to Group 2 (Control) Subjects at Week 4 Post-Start of Treatment

  Baseline, 4-weeks Post-Start of Treatment (SOT), 8-weeks Post-SOT, 3-months Post-SOT, 4-months Post-SOT, 5-months Post-SOT, 6-months Post-SOT, 7-months Post-SOT, 8-months Post-SOT, 9-months Post-SOT, 10-months Post-SOT, 11-mo Post-SOT, & 12-mo Post-SOT

• Depression at Monthly Intervals After Start of Therapy

  Baseline, 4-weeks Post-Start of Treatment (SOT), 8-weeks Post-SOT, 3-months Post-SOT, 4-months Post-SOT, 5-months Post-SOT, 6-months Post-SOT, 7-months Post-SOT, 8-months Post-SOT, 9-months Post-SOT, 10-months Post-SOT, 11-mo Post-SOT, & 12-mo Post-SOT

Study Arms (2)

SPRINT Group 1

EXPERIMENTAL

Subjects in Group 1 will have a Lead placed in the residual limb in the upper leg. These subjects will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and will receive electrical stimulation for 8 weeks.

Device: SPRINT Peripheral Nerve Stimulation (PNS) System

SPRINT Group 2

SHAM COMPARATOR

Subjects in Group 2 will have a Lead placed in the residual limb in the upper leg. These subjects will then use the SPRINT Peripheral Nerve Stimulation (PNS) System for a total of 8 weeks. They will receive 4 weeks of stimulation and 4 weeks with no stimulation.

Device: SPRINT Peripheral Nerve Stimulation (PNS) System

Interventions

SPRINT Peripheral Nerve Stimulation (PNS) System DEVICE

The SPRINT System is an Investigational Device which delivers mild electrical stimulation to nerves in the residual limb. The SPRINT System includes a small wire (called a "Lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).

Also known as: SPRINT System, SPRINT, Smartpatch System, Smartpatch

SPRINT Group 1; SPRINT Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old
• Traumatic lower extremity amputation(s)
• Healed amputation and healthy residual limb based upon the investigator's evaluation

You may not qualify if:

• Change of prescribed medications affecting pain within the past 4 weeks
• Compromised immune system based on medical history
• Implanted electronic device
• Bleeding disorder
• History of valvular heart disease
• Confounding central nervous system injuries and disorders
• History of recurrent skin infections

Sponsors & Collaborators

• SPR Therapeutics, Inc.: lead
• NDI Medical, LLC: collaborator
• United States Department of Defense: collaborator

Study Sites (10)

Arizona Pain

Scottsdale, Arizona, 85258, United States

Location

University of California San Diego

La Jolla, California, 92093, United States

Location

Denver Clinic for Extremities at Risk

Denver, Colorado, 80218, United States

Location

International Spine, Pain and Performance Center

Washington D.C., District of Columbia, 20037, United States

Location

Holy Cross Hospital

Fort Lauderdale, Florida, 33334, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Premier Pain Centers

Shrewsbury, New Jersey, 07702, United States

Location

Ainsworth Institute of Pain Management

New York, New York, 10022, United States

Location

Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Related Publications (2)

• Gilmore CA, Ilfeld BM, Rosenow JM, Li S, Desai MJ, Hunter CW, Rauck RL, Nader A, Mak J, Cohen SP, Crosby ND, Boggs JW. Percutaneous 60-day peripheral nerve stimulation implant provides sustained relief of chronic pain following amputation: 12-month follow-up of a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2019 Nov 17:rapm-2019-100937. doi: 10.1136/rapm-2019-100937. Online ahead of print.

  PMID: 31740443 DERIVED

• Gilmore C, Ilfeld B, Rosenow J, Li S, Desai M, Hunter C, Rauck R, Kapural L, Nader A, Mak J, Cohen S, Crosby N, Boggs J. Percutaneous peripheral nerve stimulation for the treatment of chronic neuropathic postamputation pain: a multicenter, randomized, placebo-controlled trial. Reg Anesth Pain Med. 2019 Jun;44(6):637-645. doi: 10.1136/rapm-2018-100109. Epub 2019 Apr 5.

  PMID: 30954936 DERIVED

Related Links

• Sponsor's Website
• Collaborator's Website

MeSH Terms

Conditions

Phantom Limb; Neuralgia

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Clinical Affairs
• Organization: SPR Therapeutics, Inc.

support@SPRTherapeutics.com

216-378-9108

Study Officials

• Josh Boggs, PhD

  SPR Therapeutics, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 27, 2013
• Study Start: October 1, 2013
• Primary Completion: January 28, 2019
• Study Completion: January 28, 2019
• Last Updated: March 26, 2020
• Results First Posted: March 26, 2020

Record last verified: 2020-03

Locations

US (10)