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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: Completed Phase 1 study of Spinal Cord Injury and Shoulder Pain, sponsored by Kessler Foundation.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Shoulder pain intensity will also be assessed weekly using a numerical rating scale (NRS). Subjects will be asked to rate their average pain, most severe pain, and least severe pain during the past week using an 11-point scale (i.e. 0-10) anchored at the ends by "no pain" and "worst pain ever experienced." An 11-point NRS measure of pain intensity allows for comparison across clinical trials of chronic pain treatment and is recommended as a core outcome measure for chronic pain clinical trials.
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 |
What the finished NCT01355549 record still lists
NCT01355549 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (93% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01355549's enrollment target sits among peer trials
6 94th of 99 higher than 5 of 99 other Spinal Cord Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injury 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.
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