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

Not Applicable

Completed

Conditions: Stroke

Interventions: Device: TENS
Device: t-NMES
Other: No stimulation

Registration Number: NCT03683901

Lead Sponsor: MetroHealth Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TENS/t-NMES/No stimulation	TENS	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.
TENS/t-NMES/No stimulation	t-NMES	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.
TENS/t-NMES/No stimulation	No stimulation	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.

Primary Outcome Measures

Name	Time	Method
Passive Range of Motion of Shoulder in Shoulder External Rotation	10 seconds	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	10 seconds	passive range of motion of shoulder in shoulder abduction as measured with hand-held goniometer

Secondary Outcome Measures