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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Shoulder Pain Rotator Cuff Tendinitis Rotator Cuff Syndrome Spinal Cord Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Platelet-rich plasma therapy

Platelet rich plasma (PRP) describes a new technology in which platelets are isolated from a sample of a person's own blood using simple cell-separating systems such as centrifugation in order to obtain highly concentrated samples of platelets that can be re-injected into an injury site to promote healing.

Group Type EXPERIMENTAL

Platelet-rich plasma (PRP) therapy

Intervention Type BIOLOGICAL

Platelet rich plasma (PRP) describes a new technology in which platelets are isolated from a sample of a person's own blood using simple cell-separating systems such as centrifugation in order to obtain highly concentrated samples of platelets that can be re-injected into an injury site to promote healing.

Interventions

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Platelet-rich plasma (PRP) therapy

Platelet rich plasma (PRP) describes a new technology in which platelets are isolated from a sample of a person's own blood using simple cell-separating systems such as centrifugation in order to obtain highly concentrated samples of platelets that can be re-injected into an injury site to promote healing.

Intervention Type BIOLOGICAL

Other Intervention Names

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Autologous blood injections

Eligibility Criteria

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Inclusion Criteria

* The subject is male or female, 18 to 60 years of age, inclusive.
* The subject has neurological impairment secondary to a spinal cord injury that occurred at least twelve (12) months prior to the Screening Visit and the level of the injury is between C6 and L5, inclusive.
* The subject is non-ambulatory except for exercise purposes and uses a manual or power wheelchair as his/her primary means of mobility (\> 40 hours/week).
* The subject currently has chronic shoulder pain due to rotator cuff disease in spite of at least 6 months of conservative treatment. Average shoulder pain intensity during the week leading up to the Screening Visit should be at least 5 out of 10 on an 11-point numerical rating scale (NRS; 0, no pain; 10, maximum pain imaginable), in spite of a past history of completing 6 months of conservative treatment. Rotator cuff disease will be defined as pain over the anterior shoulder, with direct palpation and pain at the shoulder with provocative tests for rotator cuff disease that is confirmed by tendinopathic changes on ultrasound imaging.
* The subject is able and willing to comply with the protocol.
* The subject is able to and has voluntarily given informed consent prior to the performance of any study-specific procedures.

Exclusion Criteria

* The subject reports prior PRP treatment in the same shoulder;
* The subject reports a history of systemic disorders, such as diabetes or rheumatoid arthritis;
* The subject has contra-indications to the procedure, such as infection, coagulopathy, or is currently taking anti-coagulants;
* The subject reports having a glucocorticoid injection in the past 4 weeks;
* The subject is pregnant (documented by a urine pregnancy test);
* The subject has any medical condition, including psychiatric disease, which would interfere with the interpretation of the study results or the conduct of the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No