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Electrical Stimulation for Hemiplegic Shoulder Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01123382
First Posted: May 14, 2010
Last Update Posted: December 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Case Western Reserve University
Information provided by (Responsible Party):
John Chae, MD, MetroHealth Medical Center
Results First Submitted: September 15, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Stroke
Shoulder Pain
Interventions: Device: Intramuscular Electrical Stimulator
Other: Outpatient Therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
IM Electrical Stimulation (IM ES)

The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.

Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed.

Usual Care (UC)

The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.

Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant.


Participant Flow:   Overall Study
    IM Electrical Stimulation (IM ES)   Usual Care (UC)
STARTED   13   12 
Received Intervention   12   10 
COMPLETED   11   6 
NOT COMPLETED   2   6 
Withdrawal by Subject                1                4 
Lost to Follow-up                1                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
IM Electrical Stimulation (IM ES)

The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.

Intramuscular Electrical Stimulator: A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed.

Usual Care (UC)

The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.

Outpatient Therapy: Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant.

Total Total of all reporting groups

Baseline Measures
   IM Electrical Stimulation (IM ES)   Usual Care (UC)   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   12   25 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 54.0 
 (50.5 to 68.0) 
 55.5 
 (50.0 to 62.5) 
 55.0 
 (50.0 to 65.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      6  46.2%      7  58.3%      13  52.0% 
Male      7  53.8%      5  41.7%      12  48.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White      6  46.2%      5  41.7%      11  44.0% 
African American      7  53.8%      6  50.0%      13  52.0% 
Hispanic/Latino      0   0.0%      1   8.3%      1   4.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   13   12   25 
Shoulder pain > 18 mos 
[Units: Participants]
Count of Participants
 8   7   15 
Time Since Stroke 
[Units: Years]
Median (Inter-Quartile Range)
 2.1 
 (0.9 to 4.0) 
 2.3 
 (0.8 to 4.8) 
 2.1 
 (0.9 to 4.6) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Brief Pain Inventory Short Form   [ Time Frame: Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16) ]

2.  Secondary:   ShoulderQ VGRS Scale   [ Time Frame: Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16) ]

3.  Secondary:   SF-36 Bodily Pain Component   [ Time Frame: Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16) ]

4.  Secondary:   Pain-free External ROM, Degrees   [ Time Frame: Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16) ]

5.  Secondary:   Fugl-Myer Motor Assessment (FMA) - Upper Extremity   [ Time Frame: Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16) ]

6.  Secondary:   Pain Interference Questionnaire   [ Time Frame: Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16) ]

7.  Secondary:   Isometric Shoulder Abduction Moment, Ratio Affected to Unaffected   [ Time Frame: Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16) ]

8.  Secondary:   Delay in Initiation of Shoulder Abduction EMG Activity   [ Time Frame: Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16) ]

9.  Secondary:   Delay in Termination of Shoulder Abduction EMG Activity   [ Time Frame: Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Richard WIlson, MD
Organization: MetroHealth Medical Center
phone: 216-957-3559
e-mail: rwilson@metrohealth.org


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: John Chae, MD, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT01123382     History of Changes
Other Study ID Numbers: R01HD059777 ( U.S. NIH Grant/Contract )
First Submitted: May 12, 2010
First Posted: May 14, 2010
Results First Submitted: September 15, 2017
Results First Posted: December 12, 2017
Last Update Posted: December 12, 2017