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

NCT ID: NCT03683901

Last Updated: 2019-09-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-27

Study Completion Date

2011-05-01

Brief Summary

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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.

Detailed Description

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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

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Cohort study; single group but with random serial allocation of treatment type
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Participant, Investigator, and Outcomes Assessor were masked to the particular stimulation during each range of motion assessment

Study Groups

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TENS/t-NMES/No stimulation

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.

Group Type EXPERIMENTAL

TENS

Intervention Type DEVICE

Electrical Stimulation

t-NMES

Intervention Type DEVICE

Electrical Stimulation

No stimulation

Intervention Type OTHER

No stimulation

Interventions

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TENS

Electrical Stimulation

Intervention Type DEVICE

t-NMES

Electrical Stimulation

Intervention Type DEVICE

No stimulation

No stimulation

Intervention Type OTHER

Other Intervention Names

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Transcutaneous Electrical Nerve Stimulation transcutaneous-Neuromuscular Electrical Stimulation

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MetroHealth Medical Center

OTHER

Sponsor Role lead

Responsible Party

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John Chae, MD

VP Research Instititute; Chair, Department of PM&R

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Chae, MD

Role: PRINCIPAL_INVESTIGATOR

MetroHealth Medical Center

References

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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.

Reference Type BACKGROUND
PMID: 10084443 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8291967 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2363027 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21167792 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10215661 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23255268 (View on PubMed)

Other Identifiers

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IRB10-00491

Identifier Type: -

Identifier Source: org_study_id

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