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Electrical Stimulation for the Treatment of Post-Stroke Shoulder Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by NDI Medical, LLC
Sponsor:
Information provided by (Responsible Party):
NDI Medical, LLC
ClinicalTrials.gov Identifier:
NCT01094301
First received: March 25, 2010
Last updated: September 24, 2014
Last verified: September 2014
  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 may include 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 in the first stage of the SPR System. Subjects meeting the specified success criteria at the conclusion of the SPR Trial Stage who experience a return of pain within 6 months of completion of the Trial Stage may be eligible for the second stage (SPR Implant Stage). This research study lasts a little over 3 years and may include 17 visits to the study doctor and at least 8 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 (Trial Stage Success) [ Time Frame: Baseline, 3-week (Trial Stage), 6-week (Trial Stage) ] [ Designated as safety issue: No ]
    Change in pain intensity

  • 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 ]
  • Pain Intensity (Implant Stage Success) [ Time Frame: 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 ]
    Change in pain intensity


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 ]
  • Economic Impact of Shoulder Pain [ Time Frame: Baseline ] [ 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 ]
  • Global Impact of Stimulation Therapy [ Time Frame: 3-week (Trial Stage), 6-week (Trial Stage); 3-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 ]

Estimated Enrollment: 20
Study Start Date: April 2010
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: The SPR System
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 for the first stage (SPR Trial Stage) will receive a temporary Lead and External Stimulator. 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.
Device: The SPR System
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 for the first stage (SPR Trial Stage) will receive a temporary Lead and External Stimulator. 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

Trial Stage Inclusion Criteria:

  • At least 21 years of age
  • Post-stroke shoulder pain

Trial Stage Exclusion Criteria:

  • Use of habit-forming (narcotic) medications
  • History of recurrent skin infections
  • Bleeding disorder
  • 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

Implant Stage Inclusion Criteria

  • Had a "return of pain" defined as an increase in pain of at least 2 points compared to the pain intensity score at Visit 5 and has a pain intensity score of at least 4
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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    216-957-3558      
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: September 24, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014