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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TENS/t-NMES/No stimulation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TENS | Device | Electrical Stimulation |
|
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Chae, MD | MetroHealth Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10084443 | Background | Chantraine A, Baribeault A, Uebelhart D, Gremion G. Shoulder pain and dysfunction in hemiplegia: effects of functional electrical stimulation. Arch Phys Med Rehabil. 1999 Mar;80(3):328-31. doi: 10.1016/s0003-9993(99)90146-6. | |
| 8291967 | Background | Faghri PD, Rodgers MM, Glaser RM, Bors JG, Ho C, Akuthota P. The effects of functional electrical stimulation on shoulder subluxation, arm function recovery, and shoulder pain in hemiplegic stroke patients. Arch Phys Med Rehabil. 1994 Jan;75(1):73-9. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hemiplegic Shoulder Pain | Cohort study; single group but with random serial allocation of treatment type (TENS/t-NMES/no stimulation) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants underwent all interventions.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Cross-over design. All participants underwent all interventions | Posted | Mean | 95% Confidence Interval | degrees | 10 seconds |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hemiplegic Shoulder Pain | 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. |
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Electrode placement was determined to provide best possible response for the two movements and stimulation types to maintain blinding; however, may have led to a sub-optimal location for either or both types of stimulation. Small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Victoria Whitehair | MetroHealth Rehabilitation Institute | 216-778-4414 | vwhitehair@metrohealth.org |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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Cohort study; single group but with random serial allocation of treatment type
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Participant, Investigator, and Outcomes Assessor were masked to the particular stimulation during each range of motion assessment
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| t-NMES | Device | Electrical Stimulation |
|
|
| No stimulation | Other | No stimulation |
|
| 2363027 | Background | Leandri M, Parodi CI, Corrieri N, Rigardo S. Comparison of TENS treatments in hemiplegic shoulder pain. Scand J Rehabil Med. 1990;22(2):69-71. |
| 21167792 | Background | Roosink M, Renzenbrink GJ, Buitenweg JR, van Dongen RT, Geurts AC, Ijzerman MJ. Somatosensory symptoms and signs and conditioned pain modulation in chronic post-stroke shoulder pain. J Pain. 2011 Apr;12(4):476-85. doi: 10.1016/j.jpain.2010.10.009. Epub 2010 Dec 17. |
| 10215661 | Background | Sluka KA, Deacon M, Stibal A, Strissel S, Terpstra A. Spinal blockade of opioid receptors prevents the analgesia produced by TENS in arthritic rats. J Pharmacol Exp Ther. 1999 May;289(2):840-6. |
| 23255268 | Background | Soo Hoo J, Paul T, Chae J, Wilson RD. Central hypersensitivity in chronic hemiplegic shoulder pain. Am J Phys Med Rehabil. 2013 Jan;92(1):1-9; quiz 10-3. doi: 10.1097/PHM.0b013e31827df862. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Months since stroke | Mean | Standard Deviation | months |
|
| Right sided stroke | Count of Participants | Participants |
|
| Worst shoulder pain in the last week (0 min-10 max) | Mean | Standard Deviation | units on a scale |
|
| OG002 | No Stimulation | 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 |
|
|
| 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 | Cross-over design. All participants underwent all interventions | Posted | Mean | 95% Confidence Interval | degrees | 10 seconds |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |