Trial Outcomes & Findings for The Effect of Electrical Stimulation on Impairment of the Painful Post-Stroke Shoulder (NCT NCT03683901)
NCT ID: NCT03683901
Last Updated: 2019-09-16
Results Overview
passive range of motion of shoulder in shoulder external rotation as measured with hand-held goniometer
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
10 seconds
Results posted on
2019-09-16
Participant Flow
Single group cohort study with random serial allocation of treatment type. All participants underwent each of the three stimulation conditions (TENS, t-NMES, no stimulation) three times in a computer-generated random sequence for each outcome measure with a 5-minute wash-out period between each stimulation.
Participant milestones
| Measure |
Hemiplegic Shoulder Pain
Cohort study; single group but with random serial allocation of treatment type (TENS/t-NMES/no stimulation)
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
TENS/t-NMES/No Stimulation
n=10 Participants
Electrical 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.
Electrical Stimulation-t-NMES: 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.
No stimulation: 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.
|
|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 11.3 • n=10 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=10 Participants
|
|
Months since stroke
|
46.8 months
STANDARD_DEVIATION 42.1 • n=10 Participants
|
|
Right sided stroke
|
6 Participants
n=10 Participants
|
|
Worst shoulder pain in the last week (0 min-10 max)
|
7.8 units on a scale
STANDARD_DEVIATION 2.5 • n=10 Participants
|
PRIMARY outcome
Timeframe: 10 secondsPopulation: Cross-over design. All participants underwent all interventions
passive range of motion of shoulder in shoulder external rotation as measured with hand-held goniometer
Outcome measures
| Measure |
TENS
n=10 Participants
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. Exposed to this arm 3 times for each shoulder ROM.
TENS: Electrical Stimulation
|
t-NMES
n=10 Participants
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. Exposed to this arm 3 times for each shoulder ROM.
t-NMES: Electrical Stimulation
|
No Stimulation
n=10 Participants
Device and electrodes remained in place but no stimulation was delivered over the 10 second interval. Exposed to this arm 3 times for each shoulder ROM.
No stimulation: No stimulation
|
|---|---|---|---|
|
Passive Range of Motion of Shoulder in Shoulder External Rotation
|
66.9 degrees
Interval 46.9 to 86.8
|
67.4 degrees
Interval 49.4 to 85.4
|
69.1 degrees
Interval 49.6 to 88.7
|
PRIMARY outcome
Timeframe: 10 secondsPopulation: Cross-over design. All participants underwent all interventions
passive range of motion of shoulder in shoulder abduction as measured with hand-held goniometer
Outcome measures
| Measure |
TENS
n=10 Participants
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. Exposed to this arm 3 times for each shoulder ROM.
TENS: Electrical Stimulation
|
t-NMES
n=10 Participants
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. Exposed to this arm 3 times for each shoulder ROM.
t-NMES: Electrical Stimulation
|
No Stimulation
n=10 Participants
Device and electrodes remained in place but no stimulation was delivered over the 10 second interval. Exposed to this arm 3 times for each shoulder ROM.
No stimulation: No stimulation
|
|---|---|---|---|
|
Passive Range of Motion of Shoulder in Shoulder Abduction
|
87.8 degrees
Interval 70.0 to 105.7
|
87.5 degrees
Interval 69.8 to 105.1
|
89.6 degrees
Interval 73.9 to 105.4
|
Adverse Events
Hemiplegic Shoulder Pain
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Victoria Whitehair
MetroHealth Rehabilitation Institute
Phone: 216-778-4414
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place