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NCT01123382 · ClinicalTrials.gov registry record · NA
Electrical Stimulation for Hemiplegic Shoulder Pain
A NA study, sponsored by MetroHealth Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 25
- Enrollment target
NCT01123382: Completed NA study, sponsored by MetroHealth Medical Center.
NCT01123382 is a NA study that has completed, run by MetroHealth Medical Center. The registered enrollment target is 25 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01123382, a NA study, has completed, sponsored by MetroHealth Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
Study Summary
Post-stroke shoulder pain is a major rehabilitation problem affecting moderate to severely impaired stroke survivors. Surface electrical stimulation (ES) of muscles surrounding the hemiparetic shoulder has been demonstrated to be beneficial, but despite the evidence for therapeutic benefit, the clinical implementation of surface ES for poststroke shoulder pain has been difficult. In order to address the limitations of surface ES, the investigative team pioneered the development of percutaneous intramuscular (IM) ES for the treatment of post-stroke shoulder pain. However, prior to acceptance by the clinical community, additional gaps in the scientific and clinical knowledge need to be addressed. This study begins to do so. The primary objective is to estimate the relative pain reduction associated with IM ES vs. "usual care." We hypothesize that the IM ES group will exhibit a larger effect size with respect to pain reduction compared to "usual care". A secondary objective is to estimate the effect on health related QOL of IM ES vs. "usual care." Demonstration of improvement in QOL will validate the clinical relevance of the intervention. We hypothesize that the IM ES group will exhibit greater improvement in health related QOL compared to "usual care".
Primary Outcome
The BPI is a pain questionnaire, which assesses both pain intensity (sensory dimension) and the interference (reactive dimension) of pain in daily activities. Pain intensity is measured on a 0 - 10 scale, with 0 being no pain and 10 being worst possible.
Interventions
- DEVICE Intramuscular Electrical Stimulator
- OTHER Outpatient Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2010-01 |
| Est. Completion | 2013-02 |
| Phase | NA |
What the finished NCT01123382 record still lists
NCT01123382 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Intramuscular Electrical Stimulator is the first listed.
NCT01123382 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01123382 about?
NCT01123382 is a clinical study titled "Electrical Stimulation for Hemiplegic Shoulder Pain". Post-stroke shoulder pain is a major rehabilitation problem affecting moderate to severely impaired stroke survivors. Surface electrical stimulation (ES) of muscles surrounding the hemiparetic shoulder has been demonstrated to be beneficial, but despite the evidence for therapeutic benefit, the clin...
What is the current status of trial NCT01123382?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2010-01. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01123382?
The interventions under investigation include: Intramuscular Electrical Stimulator (DEVICE), Outpatient Therapy (OTHER).
Who is sponsoring clinical trial NCT01123382?
This trial is sponsored by MetroHealth Medical Center, which has 76 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01123382's enrollment target sits among peer trials
25 1712th of 2000 higher than 265 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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