Clinical trial NCT01355549: Platelet-Rich Plasma Therapy for Shoulder Pain in Persons With Spinal Cord Injury
Official title: A Pilot Study to Evaluate the Feasibility of Platelet-Rich Plasma Therapy as a Treatment for Chronic Shoulder Pain in Persons With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Shoulder Pain
Rotator Cuff Tendinitis
Rotator Cuff Syndrome
Spinal Cord Injury
Keywords: Shoulder pain
Rotator cuff disease
Spinal cord injuries
Platelet-rich plasma therapy
Rehabilitation
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2011-05-18
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Numerical Rating Scale (NRS)
timeFrame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the PRP treatment.
Secondary outcomes:
measure: Wheelchair User's Shoulder Pain Index (WUSPI)
timeFrame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the PRP treatment.
measure: Patient Global Impression of Change
timeFrame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the PRP treatment.
measure: Brief Pain Inventory interference items (BPI-I)
timeFrame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the PRP treatment.
measure: Rotator Cuff Disease Score
timeFrame: Baseline and at the 12-Week and 24-Weeks Follow-up Visit after the PRP treatment.
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Institute for Rehabilitation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Trevor A. Dyson-Hudson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dyson-Hudson TA, Hogaboom NS, Nakamura R, Terry A, Malanga GA. Ultrasound-guided platelet-rich plasma injection for the treatment of recalcitrant rotator cuff disease in wheelchair users with spinal cord injury: A pilot study. J Spinal Cord Med. 2022 Jan;45(1):42-48. doi: 10.1080/10790268.2020.1754676. Epub 2020 May 7.