StrokeNCT03683901

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

A study testing TENS, t-NMES and No stimulation in people with Stroke, run by MetroHealth Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 21 to 89 years
Conditions the study is for: Stroke
What is being tested?: TENS, t-NMES and No stimulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: No sites listed yet
Study dates: 27 Dec 2010to 1 May 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 89 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

history of tachyarrhythmia with decreased blood pressure
uncontrolled seizures (defined as more than one per month)
an implanted electrical device
uncompensated hemi-neglect

About this study

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.

Read the 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.

Conditions: Stroke
Being tested: TENS, t-NMES, No stimulation
Keywords: Electrical stimulation therapy, TENS, t-NMES, Stroke
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TENSDevice
Also called Transcutaneous Electrical Nerve Stimulation
Electrical Stimulation
t-NMESDevice
Also called transcutaneous-Neuromuscular Electrical Stimulation
Electrical Stimulation
No stimulationOther
No stimulation

Study groups in NCT03683901
Study group	Role	What they receive
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. Receives: Device: TENS; Device: t-NMES; Other: No stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 10 seconds

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Dec 20101 May 2011

First posted25 Sep 2018
Study start27 Dec 2010
Primary completion1 May 2011
Study completion1 May 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Cohort study; single group but with random serial allocation of treatment type
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03683901
Sponsor's protocol ID: IRB10-00491
Status last verified: Aug 2019
First submitted: 23 Sep 2018
Last updated: 16 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 10084443
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.
PubMed 8291967
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.
PubMed 2363027
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.
PubMed 21167792
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.
PubMed 10215661
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.
PubMed 23255268

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Electrical Stimulation on Impairment of the Painful Post-Stroke Shoulder
ClinicalTrials.gov ID: NCT03683901
Acronym / sponsor ID: IRB10-00491
Conditions: Stroke
Keywords: Electrical stimulation therapy, TENS, t-NMES, Stroke
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: MetroHealth Medical CenterUniversity, hospital or other
Study start: 27 Dec 2010 (actual)
Primary completion: 1 May 2011 (actual)
Study completion: 1 May 2011 (actual)
First posted: 25 Sep 2018 (actual)
Results: Posted 16 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Cohort study; single group but with random serial allocation of treatment type

Arm	Type	Receives
TENS/t-NMES/No stimulation	Experimental	Device: TENS, Device: t-NMES, Other: No stimulationTENS 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.

Who may qualify

Ages: 21 to 89 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

history of tachyarrhythmia with decreased blood pressure
uncontrolled seizures (defined as more than one per month)
an implanted electrical device
uncompensated hemi-neglect

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TENSAlso: Transcutaneous Electrical Nerve StimulationElectrical Stimulation	Device	TENS/t-NMES/No stimulation
t-NMESAlso: transcutaneous-Neuromuscular Electrical StimulationElectrical Stimulation	Device	TENS/t-NMES/No stimulation
No stimulationNo stimulation	Other	TENS/t-NMES/No stimulation

Primary outcome

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

Results and safety

Results posted to the registry on 16 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hemiplegic Shoulder Pain	10	10

Primary outcome: Passive Range of Motion of Shoulder in Shoulder External Rotation

Time frame: 10 seconds. Mean (95% Confidence Interval). Unit: degrees

Measure	TENS n = 10	t-NMES n = 10	No Stimulation n = 10
Value	66.9 (46.9 to 86.8)	67.4 (49.4 to 85.4)	69.1 (49.6 to 88.7)

Population analysed: Cross-over design. All participants underwent all interventions

Primary outcome: Passive Range of Motion of Shoulder in Shoulder Abduction

Time frame: 10 seconds. Mean (95% Confidence Interval). Unit: degrees

Measure	TENS n = 10	t-NMES n = 10	No Stimulation n = 10
Value	87.8 (70.0 to 105.7)	87.5 (69.8 to 105.1)	89.6 (73.9 to 105.4)

Population analysed: Cross-over design. All participants underwent all interventions

Adverse events

Time frame: 1 day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hemiplegic Shoulder Pain	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 10084443Chantraine 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.
Background: PubMed 8291967Faghri 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.
Background: PubMed 2363027Leandri M, Parodi CI, Corrieri N, Rigardo S. Comparison of TENS treatments in hemiplegic shoulder pain. Scand J Rehabil Med. 1990;22(2):69-71.
Background: PubMed 21167792Roosink 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.
Background: PubMed 10215661Sluka 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.
Background: PubMed 23255268Soo 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.
Individual participant dataSharing planned: No

Related trials for Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Chae, MD principal investigator

MetroHealth Medical Center

Questions about this trial

What is this clinical trial studying?

A study testing TENS, t-NMES and No stimulation in people with Stroke, run by MetroHealth Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Passive Range of Motion of Shoulder in Shoulder External Rotation (time frame: 10 seconds). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03683901, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2019.