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

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.