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Completed

NCT Number: NCT03683901

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

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.

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Key information

Age range

21 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TENS

Device

Electrical Stimulation

Other names: Transcutaneous Electrical Nerve Stimulation

t-NMES

Device

Electrical Stimulation

Other names: transcutaneous-Neuromuscular Electrical Stimulation

No stimulation

Other

No stimulation

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

MetroHealth Medical Center

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 25, 2018
Registry last updated
Sep 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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