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NCT01355549 · ClinicalTrials.gov registry record · Phase 1
Platelet-Rich Plasma Therapy for Shoulder Pain in Persons With Spinal Cord Injury
A Phase 1 study of Spinal Cord Injury and Shoulder Pain, sponsored by Kessler Foundation.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT01355549 is a Phase 1 study of Spinal Cord Injury and Shoulder Pain that has completed, run by Kessler Foundation. The registered enrollment target is 6 participants, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01355549, a Phase 1 study of Spinal Cord Injury and Shoulder Pain, has completed, sponsored by Kessler Foundation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
Shoulder pain is common in persons with spinal cord injury (SCI). It is most often caused by overuse injuries to the muscles and tendons that can occur during wheelchair propulsion, transfers, and other activities of daily living. Normally, shoulder pain resolves with conservative treatments such non-steroidal anti-inflammatory drugs (e.g. aspirin, ibuprofen, naproxen, etc.) and physical therapy. However, when these treatments fail, shoulder surgery may be the only option. Platelet Rich Plasma therapy, or PRP, is a treatment option for non-healing muscle and tendon injuries such as those that cause shoulder pain in persons with SCI. Using one's own blood, cells within the blood called "platelets" are concentrated and then re-injected into the muscle and tendon of the shoulder. These platelets release substances known as "growth factors" that lead to tissue healing. By concentrating the platelets we increase the growth factors up to eight times which will promote the healing of tendons. PRP therapy has shown promise in treating tendon and muscle injuries in able-bodied persons; however, its effectiveness in persons with SCI is unknown. The purpose of this study is to explore the feasibility, safety, and efficacy of PRP therapy for chronic shoulder pain in persons with SCI. The human body has a remarkable ability to heal itself and we hypothesize that re-injecting concentrated platelets will facilitate the natural healing process and will reduce shoulder pain in persons with SCI.
Conditions Studied
Interventions
- BIOLOGICAL Platelet-rich plasma (PRP) therapy
Study Locations (1)
New Jersey
- Kessler Institute for Rehabilitation - West Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01355549
The ClinicalTrials.gov registry entry for NCT01355549 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (93% lower). The listed sponsor is Kessler Foundation, which has 104 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Spinal Cord Injury appearing as the primary indexed condition, and to 1 intervention - of which Platelet-rich plasma (PRP) therapy is the first listed.
NCT01355549 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.
Frequently Asked Questions
What is clinical trial NCT01355549 about?
NCT01355549 is a clinical study titled "Platelet-Rich Plasma Therapy for Shoulder Pain in Persons With Spinal Cord Injury". Shoulder pain is common in persons with spinal cord injury (SCI). It is most often caused by overuse injuries to the muscles and tendons that can occur during wheelchair propulsion, transfers, and other activities of daily living. Normally, shoulder pain resolves with conservative treatments such no...
What is the current status of trial NCT01355549?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2011-05. Estimated completion is 2012-11.
What conditions does trial NCT01355549 study?
This clinical trial studies the following conditions: Spinal Cord Injury, Shoulder Pain, Rotator Cuff Tendinitis, Rotator Cuff Syndrome.
What interventions are being tested in trial NCT01355549?
The interventions under investigation include: Platelet-rich plasma (PRP) therapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT01355549?
This trial is sponsored by Kessler Foundation, which has 104 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01355549 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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