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COMPLETED Phase 1

Platelet-Rich Plasma Therapy for Shoulder Pain in Persons With Spinal Cord Injury

NCT01355549 · View on ClinicalTrials.gov ↗

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.

Interventions

  • BIOLOGICAL Platelet-rich plasma (PRP) therapy

Study Locations (1)

New Jersey

  • Kessler Institute for Rehabilitation — West Orange

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2011-05
Est. Completion 2012-11
Phase Phase 1

Sponsor

Kessler Foundation

363 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kessler Foundation, which has 363 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01355549 reports 1 study location spanning 1 distinct geographic area — top geographies include New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01355549?

The interventions under investigation include: Platelet-rich plasma (PRP) therapy (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01355549?

This trial is sponsored by Kessler Foundation, which has 363 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial