Electrical Stimulation for the Treatment of Chronic Post-Stroke Shoulder Pain Using the Smartpatch System

NCT01847885 | Completed Results DMC

• 1 other identifier: 0131-CSP-000
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to determine if electrical stimulation (small levels of electricity) reduces post-stroke shoulder pain. This study involves a device called the Smartpatch System. The Smartpatch System delivers mild electrical stimulation to the muscles in the shoulder. The Smartpatch System includes a small wire (called a "Lead") that is placed through the skin into the muscle of the shoulder. It also includes a device worn on the body that delivers stimulation (called the Smartpatch Stimulator).

Conditions

Post-stroke Shoulder Pain; Hemiplegic Shoulder Pain

Keywords

electrical stimulation; neurostimulation; neuromodulation; post-stroke shoulder pain; hemiplegic shoulder pain

Outcome Measures

Primary Outcomes (2)

• Change From Baseline Shoulder Pain Intensity at End of Treatment (EOT)

  A diary was used in the study to capture daily worst shoulder pain intensity over a 7-day period. The diary included a pain intensity question asked each day to the subject. The pain intensity question is excerpted from the Brief Pain Inventory - Short Form Question 3 (BPI-3) and is stated as "please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours". BPI-3 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. The median scores were calculated for each diary period. The median diary score at End of Treatment (EOT) was compared to the median baseline diary score to calculate the change in pain intensity. The group mean of the median scores for treatment was compared to the group mean of the medians scores for the control group at baseline and at EOT.

  Baseline, End of Treatment (4-weeks of Treatment/Control)

• Number of Participants With Device Related Adverse Event Rates in Treatment and Control Groups

  At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.

  16 weeks total - 4 weeks from baseline visit to EOT visit, followed by 12 weeks post-treatment

Secondary Outcomes (7)

• Change From Baseline Shoulder Pain Interference at End of Treatment

  Baseline, End of Treatment (4-weeks of Treatment/Control)

• Durability of Change From Baseline Shoulder Pain Intensity at 12-weeks Beyond Treatment

  Baseline, 12-wks post-treatment

• Change From Baseline Quality of Life at End of Treatment

  Baseline, End of Treatment (4-weeks of Treatment/Control)

• Change From Baseline Average Pain Intensity at End of Treatment

  Baseline, End of Treatment (4-weeks of Treatment/Control)

• Patient Global Impression of Change at End of Treatment

  End of Treatment (4-weeks of Treatment/Control)

Other Outcomes (3)

• User Satisfaction With The Smartpatch System at End of Treatment

  End of Treatment (4-weeks of Treatment/Control)

• User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment

  12-week post-treatment

• Performance of the Smartpatch System

  At completion of study, approximately 2.5 years

Study Arms (2)

Smartpatch Treatment Group

EXPERIMENTAL

Subjects in the Treatment Group will have a Smartpatch Lead placed in the shoulder, will use the Smartpatch Peripheral Nerve Stimulation (PNS) System, and will receive electrical stimulation.

Device: Smartpatch Peripheral Nerve Stimulation (PNS) System

Smartpatch Control Group

SHAM COMPARATOR

Subjects in the Control Group will have a Smartpatch Lead placed in the shoulder, will use the Smartpatch Peripheral Nerve Stimulation (PNS) System, but will not receive any electrical stimulation.

Device: Smartpatch Peripheral Nerve Stimulation (PNS) System

Interventions

Smartpatch Peripheral Nerve Stimulation (PNS) System DEVICE

The Smartpatch System is an Investigation Device which delivers mild electrical stimulation to the muscles in the shoulder. The Smartpatch System includes a small wire (called a "Lead") that is placed through the skin into the muscle of the shoulder. It also includes a device worn on the body that delivers stimulation (called the Smartpatch Stimulator).

Also known as: Smartpatch System, Smartpatch

Smartpatch Control Group; Smartpatch Treatment Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 21 years of age
• Post-stroke shoulder pain
• At least 6 months after stroke that caused shoulder pain

You may not qualify if:

• Use of habit-forming (narcotic) medications
• Bleeding disorder
• History of recurrent skin infections
• Parkinson's Disease, Spinal Cord Injury, traumatic brain injury, Multiple Sclerosis, or Complex Regional Pain Syndrome
• Heart arrhythmia or artificial heart valves
• Uncontrolled seizures
• Implanted Electronic Device
• Pregnant

Sponsors & Collaborators

• SPR Therapeutics, Inc.: lead

Study Sites (5)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Kessler Foundation Research Center

West Orange, New Jersey, 07052, United States

Location

Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Carolinas Rehabilitation/Carolinas Healthcare

Charlotte, North Carolina, 28203, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Limitations and Caveats

This study included a pre-planned interim analysis for sample size re-estimation. The study was suspended because the treatment effect (both groups experienced clinically significant reductions in pain) required a sample size more than 90 subjects.

Results Point of Contact

• Title: Clinical Affairs
• Organization: SPR Therapeutics

support@SPRTherapeutics.com

216-378-9108

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• 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: April 23, 2013
• First Posted: May 7, 2013
• Study Start: April 1, 2013
• Primary Completion: August 21, 2015
• Study Completion: November 14, 2016
• Last Updated: October 16, 2017
• Results First Posted: October 16, 2017

Record last verified: 2017-10

Locations

US (5)