Electrical Stimulation for the Treatment of Post-Stroke Shoulder Pain - Full Text View

Purpose

Post-stroke shoulder pain is defined as pain in the shoulder area that starts after a person has had a stroke. The SPR System is an investigational device that is being studied for the relief of post-stroke shoulder pain. The SPR System uses electrical stimulation and includes a Trial Stage (where a temporary system is used to see if the subject may benefit from this type of therapy) and an Implant Stage (where a small device is implanted under the skin in the chest). The SPR System delivers mild electrical stimulation to the muscles in the shoulder where the subject feels pain. This research study will evaluate the effect of electrical stimulation on shoulder pain.

Individuals who are over the age of 21, who had a stroke at least six months ago, who experience shoulder pain, and have tried other therapies for their shoulder pain, may be eligible to participate. This research study lasts a little over 3 years and includes 15 visits to the study doctor and 6 telephone calls from study staff.

Condition	Intervention
Shoulder Pain	Device: The SPR System

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Prospective Multi-Center Pilot Study of the SPR™ System for the Treatment of Post-Stroke Shoulder Pain

Further study details as provided by NDI Medical, LLC:

Primary Outcome Measures:

Pain Intensity [ Time Frame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage); 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON (Implant Stage) ] [ Designated as safety issue: No ]
Device Related Adverse Events [ Time Frame: Baseline, 48-hour visit, 3-week (Trial Stage), 6-week (Trial Stage); 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON (Implant Stage) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pain Interference [ Time Frame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage); 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON (Implant Stage) ] [ Designated as safety issue: No ]
Pain-Free Passive Range of Motion [ Time Frame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage); 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage) ] [ Designated as safety issue: No ]
Quality of Life [ Time Frame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage); 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage) ] [ Designated as safety issue: No ]
Impact of Stimulation Therapy [ Time Frame: 3-week (Trial Stage), 6-week (Trial Stage); 3-weeks,12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage) ] [ Designated as safety issue: No ]
Emotional Functioning [ Time Frame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage); 3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage) ] [ Designated as safety issue: No ]
User Satisfaction [ Time Frame: 6-week (Trial Stage);12-weeks,12-months post IPG-Stim ON (Implant Stage) ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	April 2010
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Intervention Details:

The SPR System is an investigational two-staged device which delivers stimulation to the muscles in the shoulder. Subjects with chronic post-stroke shoulder pain who meet eligibility criteria will receive the System. The first stage (SPR Trial Stage) involves a temporary Lead and an External Stimulator, which the patients uses to trial the therapy. Subjects who qualify and who agreed to proceed will advance to the second stage (SPR Implant Stage) which uses an Implantable Pulse Generator (IPG) and Implantable Lead. Subjects will be followed until 36-months after IPG stimulation has been started.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

At least 21 years of age
Post-stroke shoulder pain

Exclusion Criteria:

Use of habit-forming (narcotic) medications
Poorly controlled diabetes
Bleeding disorder
Parkinson's Disease, Spinal Cord Injury, traumatic brain injury, MS, or complex regional pain syndrome
Heart arrhythmia or artificial heart valves
Uncontrolled seizures
Implanted Electronic Device

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01094301

Locations

United States, New York
Weill Cornell Medical Center	Completed
New York, New York, United States, 10065
United States, North Carolina
Carolinas Healthcare System/Carolinas Rehabilitation	Active, not recruiting
Charlotte, North Carolina, United States, 28203
United States, Ohio
MetroHealth Medical Center	Recruiting
Cleveland, Ohio, United States, 44109
Contact: Margaret Maloney, RN 216-778-8563
Principal Investigator: John Chae, MD
United States, Pennsylvania
Moss Rehab/ Albert Einstein Healthcare Network	Active, not recruiting
Elkins Park, Pennsylvania, United States, 19027

Sponsors and Collaborators

NDI Medical, LLC

More Information

No publications provided

Responsible Party:	NDI Medical, LLC
ClinicalTrials.gov Identifier:	NCT01094301 History of Changes
Other Study ID Numbers:	NDI-0122-CSP-001
Study First Received:	March 25, 2010
Last Updated:	October 3, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by NDI Medical, LLC:

electrical stimulation
neurostimulation
neuromodulation

shoulder pain
post-stroke shoulder pain
hemiplegic shoulder pain

Additional relevant MeSH terms:

Shoulder Pain
Stroke
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms

Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013