search
Back to results

The Effect of Electrical Stimulation on Impairment of the Painful Post-Stroke Shoulder

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TENS
t-NMES
No stimulation
Sponsored by
MetroHealth Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Electrical stimulation therapy, TENS, t-NMES, Stroke

Eligibility Criteria

21 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • at least 3 months post-stroke
  • worst shoulder pain in the last week at least 4 on the 0-10 numerical rating scale,
  • adequate cognitive ability to be able to rate their pain in the past week

Exclusion Criteria:

  • history of tachyarrhythmia with decreased blood pressure
  • uncontrolled seizures (defined as more than one per month)
  • an implanted electrical device
  • uncompensated hemi-neglect

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    TENS/t-NMES/No stimulation

    Arm Description

    TENS stimulation parameters were of a symmetric waveform, a frequency of 100 Hz, and a pulse duration of 300 microseconds (EMPI 300PVTM program PPR #7) applied for 10 seconds. t-NMES parameters were a symmetric waveform with 2 second ramp-up and 2 second ramp-down, a frequency of 35Hz, and a pulse duration of 300 microseconds (EMPI 300PVTM program PPR #3). The t-NMES current intensity was set by adjusting the amplitude to yield the strongest contraction of the underlying muscles without initiating pain. Device and electrodes remained in place but no stimulation was delivered over the 10 second interval. Exposed to each stimulation 3 times for each shoulder ROM.

    Outcomes

    Primary Outcome Measures

    Passive Range of Motion of Shoulder in Shoulder External Rotation
    passive range of motion of shoulder in shoulder external rotation as measured with hand-held goniometer
    Passive Range of Motion of Shoulder in Shoulder Abduction
    passive range of motion of shoulder in shoulder abduction as measured with hand-held goniometer

    Secondary Outcome Measures

    Full Information

    First Posted
    September 23, 2018
    Last Updated
    August 13, 2019
    Sponsor
    MetroHealth Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03683901
    Brief Title
    The Effect of Electrical Stimulation on Impairment of the Painful Post-Stroke Shoulder
    Official Title
    The Effect of Electrical Stimulation on Impairment of the Painful Post-Stroke Shoulder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 27, 2010 (Actual)
    Primary Completion Date
    May 1, 2011 (Actual)
    Study Completion Date
    May 1, 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    MetroHealth Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Examination of the effects of short-term use of TENS and t-NMES on passive pain-free ROM of the painful post-stroke shoulder. Treatments are compared with no stimulation.
    Detailed Description
    Single cohort, cross-over study. Subjects undergo passive pain-free ROM of the painful post-stroke shoulder under 3 stimulation conditions. The stimulation was delivered by a trained occupational therapist under three conditions: 10 seconds of TENS, 10 seconds of t-NMES, and 10 seconds of no stimulation. Each subject was exposed to each of the three stimulation conditions three times in a computer-generated random sequence for each outcome measure with a 5-minute wash-out period between each stimulation. This protocol is repeated for each of the two passive movements tested, shoulder abduction and shoulder external rotation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    Electrical stimulation therapy, TENS, t-NMES, Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Cohort study; single group but with random serial allocation of treatment type
    Masking
    None (Open Label)
    Masking Description
    Participant, Investigator, and Outcomes Assessor were masked to the particular stimulation during each range of motion assessment
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TENS/t-NMES/No stimulation
    Arm Type
    Experimental
    Arm Description
    TENS stimulation parameters were of a symmetric waveform, a frequency of 100 Hz, and a pulse duration of 300 microseconds (EMPI 300PVTM program PPR #7) applied for 10 seconds. t-NMES parameters were a symmetric waveform with 2 second ramp-up and 2 second ramp-down, a frequency of 35Hz, and a pulse duration of 300 microseconds (EMPI 300PVTM program PPR #3). The t-NMES current intensity was set by adjusting the amplitude to yield the strongest contraction of the underlying muscles without initiating pain. Device and electrodes remained in place but no stimulation was delivered over the 10 second interval. Exposed to each stimulation 3 times for each shoulder ROM.
    Intervention Type
    Device
    Intervention Name(s)
    TENS
    Other Intervention Name(s)
    Transcutaneous Electrical Nerve Stimulation
    Intervention Description
    Electrical Stimulation
    Intervention Type
    Device
    Intervention Name(s)
    t-NMES
    Other Intervention Name(s)
    transcutaneous-Neuromuscular Electrical Stimulation
    Intervention Description
    Electrical Stimulation
    Intervention Type
    Other
    Intervention Name(s)
    No stimulation
    Intervention Description
    No stimulation
    Primary Outcome Measure Information:
    Title
    Passive Range of Motion of Shoulder in Shoulder External Rotation
    Description
    passive range of motion of shoulder in shoulder external rotation as measured with hand-held goniometer
    Time Frame
    10 seconds
    Title
    Passive Range of Motion of Shoulder in Shoulder Abduction
    Description
    passive range of motion of shoulder in shoulder abduction as measured with hand-held goniometer
    Time Frame
    10 seconds

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    89 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: at least 3 months post-stroke worst shoulder pain in the last week at least 4 on the 0-10 numerical rating scale, adequate cognitive ability to be able to rate their pain in the past week Exclusion Criteria: history of tachyarrhythmia with decreased blood pressure uncontrolled seizures (defined as more than one per month) an implanted electrical device uncompensated hemi-neglect
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John Chae, MD
    Organizational Affiliation
    MetroHealth Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    10084443
    Citation
    Chantraine A, Baribeault A, Uebelhart D, Gremion G. Shoulder pain and dysfunction in hemiplegia: effects of functional electrical stimulation. Arch Phys Med Rehabil. 1999 Mar;80(3):328-31. doi: 10.1016/s0003-9993(99)90146-6.
    Results Reference
    background
    PubMed Identifier
    8291967
    Citation
    Faghri PD, Rodgers MM, Glaser RM, Bors JG, Ho C, Akuthota P. The effects of functional electrical stimulation on shoulder subluxation, arm function recovery, and shoulder pain in hemiplegic stroke patients. Arch Phys Med Rehabil. 1994 Jan;75(1):73-9.
    Results Reference
    background
    PubMed Identifier
    2363027
    Citation
    Leandri M, Parodi CI, Corrieri N, Rigardo S. Comparison of TENS treatments in hemiplegic shoulder pain. Scand J Rehabil Med. 1990;22(2):69-71.
    Results Reference
    background
    PubMed Identifier
    21167792
    Citation
    Roosink M, Renzenbrink GJ, Buitenweg JR, van Dongen RT, Geurts AC, Ijzerman MJ. Somatosensory symptoms and signs and conditioned pain modulation in chronic post-stroke shoulder pain. J Pain. 2011 Apr;12(4):476-85. doi: 10.1016/j.jpain.2010.10.009. Epub 2010 Dec 17.
    Results Reference
    background
    PubMed Identifier
    10215661
    Citation
    Sluka KA, Deacon M, Stibal A, Strissel S, Terpstra A. Spinal blockade of opioid receptors prevents the analgesia produced by TENS in arthritic rats. J Pharmacol Exp Ther. 1999 May;289(2):840-6.
    Results Reference
    background
    PubMed Identifier
    23255268
    Citation
    Soo Hoo J, Paul T, Chae J, Wilson RD. Central hypersensitivity in chronic hemiplegic shoulder pain. Am J Phys Med Rehabil. 2013 Jan;92(1):1-9; quiz 10-3. doi: 10.1097/PHM.0b013e31827df862.
    Results Reference
    background

    Learn more about this trial

    The Effect of Electrical Stimulation on Impairment of the Painful Post-Stroke Shoulder

    We'll reach out to this number within 24 hrs