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

MetroHealth Medical Center

Status: Completed

Conditions: Stroke

Treatments: Device: TENS; Other: No stimulation; Device: t-NMES

Study type: Interventional

Funder types: Other

Identifiers

NCT03683901

IRB10-00491

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 21 to 89 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

TENS/t-NMES/No stimulation

Experimental group

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.

Treatment:

Other: No stimulation

Device: t-NMES

Device: TENS