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NCT01094301 · ClinicalTrials.gov registry record · NA
Electrical Stimulation for the Treatment of Post-Stroke Shoulder Pain
A NA study, sponsored by SPR Therapeutics.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
NCT01094301: Completed NA study, sponsored by SPR Therapeutics.
NCT01094301 is a NA study that has completed, run by SPR Therapeutics. The registered enrollment target is 28 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
NCT01094301, a NA study, has completed, sponsored by SPR Therapeutics.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
Study Summary
Post-stroke shoulder pain is defined as pain in the shoulder area that starts after a person has had a stroke. The SPR System is an investigational device that is being studied for the relief of post-stroke shoulder pain. The SPR System uses electrical stimulation and includes a Trial Stage (where a temporary system is used to see if the subject may benefit from this type of therapy) and may include an Implant Stage (where a small device is implanted under the skin in the chest). The SPR System delivers mild electrical stimulation to the shoulder where the subject feels pain. This research study will evaluate the effect of electrical stimulation on shoulder pain. Individuals who are over the age of 21, who had a stroke at least six months ago, who experience shoulder pain, and have tried other therapies for their shoulder pain, may be eligible to participate in the first stage of the SPR System. Subjects meeting the specified success criteria at the conclusion of the SPR Trial Stage who experience a return of pain within 6 months of completion of the Trial Stage may be eligible for the second stage (SPR Implant Stage). This research study lasts a little over 3 years and may include 17 visits to the study doctor and at least 8 telephone calls from study staff.
Primary Outcome
Subjects were asked to report their worst pain score on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average scores across subjects were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Treatment).
Interventions
- DEVICE The SPR System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2010-04 |
| Est. Completion | 2017-07-25 |
| Phase | NA |
What the finished NCT01094301 record still lists
NCT01094301 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 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 1 intervention - of which The SPR System is the first listed.
NCT01094301 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01094301 about?
NCT01094301 is a clinical study titled "Electrical Stimulation for the Treatment of Post-Stroke Shoulder Pain". Post-stroke shoulder pain is defined as pain in the shoulder area that starts after a person has had a stroke. The SPR System is an investigational device that is being studied for the relief of post-stroke shoulder pain. The SPR System uses electrical stimulation and includes a Trial Stage (where a...
What is the current status of trial NCT01094301?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2010-04. Estimated completion is 2017-07-25.
What interventions are being tested in trial NCT01094301?
The interventions under investigation include: The SPR System (DEVICE).
Who is sponsoring clinical trial NCT01094301?
This trial is sponsored by SPR Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01094301's enrollment target sits among peer trials
28 1704th of 2000 higher than 293 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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