Stroke
Conditions
Keywords
Electrical stimulation therapy, TENS, t-NMES, Stroke
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.
Interventions
Sponsors
MetroHealth Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Participant, Investigator, and Outcomes Assessor were masked to the particular stimulation during each range of motion assessment
Intervention model description
Cohort study; single group but with random serial allocation of treatment type
Eligibility
Sex/Gender
ALL
Age
21 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| TENS/t-NMES/No Stimulation 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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | TENS/t-NMES/No Stimulation | — |
|---|---|---|
| Age, Continuous | 59.1 years STANDARD_DEVIATION 11.3 | — |
| Months since stroke | 46.8 months STANDARD_DEVIATION 42.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Right sided stroke | 6 Participants | — |
| Sex: Female, Male Female | 6 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
| Worst shoulder pain in the last week (0 min-10 max) | 7.8 units on a scale STANDARD_DEVIATION 2.5 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Passive Range of Motion of Shoulder in Shoulder Abduction
passive range of motion of shoulder in shoulder abduction as measured with hand-held goniometer
Time frame: 10 seconds
Population: Cross-over design. All participants underwent all interventions
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TENS | Passive Range of Motion of Shoulder in Shoulder Abduction | 87.8 degrees |
| t-NMES | Passive Range of Motion of Shoulder in Shoulder Abduction | 87.5 degrees |
| No Stimulation | Passive Range of Motion of Shoulder in Shoulder Abduction | 89.6 degrees |
Primary
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
Time frame: 10 seconds
Population: Cross-over design. All participants underwent all interventions
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TENS | Passive Range of Motion of Shoulder in Shoulder External Rotation | 66.9 degrees |
| t-NMES | Passive Range of Motion of Shoulder in Shoulder External Rotation | 67.4 degrees |
| No Stimulation | Passive Range of Motion of Shoulder in Shoulder External Rotation | 69.1 degrees |