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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Device: TENS
* Device: t-NMES
* Other: No stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Cohort study; single group but with random serial allocation of treatment type
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TENS/t-NMES/No stimulation<br>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. | Device: TENS<br>* Electrical Stimulation<br>* Other names: Transcutaneous Electrical Nerve Stimulation;Device: t-NMES<br>* Electrical Stimulation<br>* Other names: transcutaneous-Neuromuscular Electrical Stimulation;Other: No stimulation<br>* No stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 10 seconds | 
| Passive Range of Motion of Shoulder in Shoulder Abduction | passive range of motion of shoulder in shoulder abduction as measured with hand-held goniometer | 10 seconds | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TENS, Electrical stimulation therapy, t-NMES, Stroke