Clinical trial NCT01123889: Treatment of the Rotator Cuff Disease With Platelet Rich Plasma Injection
Official title: Treatment of Rotator Cuff Syndrome With Injection of Autologous Platelet Rich Plasma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacromial Impingement Syndrome
Partial Thickness Rotator Cuff Tear
Keywords: subacromial impingement
partial thickness rotator cuff
PRP
platelet rich plasma
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2010-05-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this investigator initiated study is to clinically evaluate the efficacy of a new treatment for subacromial impingement syndrome and partial thickness rotator cuff tears. This treatment consists of a platelet rich plasma injection into and around the rotator cuff. It is thought that this treatment will dramatically improve outcomes for patients suffering from these two conditions.

Subjects will be randomized by choosing a slip of paper from an envelope. This process will randomize 25 patients to the experimental group, and 25 patients to the control. The experimental group will undergo a blood draw, allowing for an injection of platelet rich plasma around the rotator cuff. The control group will undergo a corticosteroid injection into the subacromial space surrounding the rotator cuff as sole treatment. Patients will be followed for three months for pain, and will fill out questionnaires at six weeks and three months post injection, which will give insight into functionality and pain changes that the rotator cuff is experiencing due to treatment.

Subjects will be outpatients. Subjects may include employees, students, minorities, and elderly, although no subsets of these will be formed.

Subjects will be between 18 and 89 years of age.

In total, subject participation will last approximately 3 months.


Eligibility criteria: Inclusion Criteria:

1. Patients presenting with rotator cuff symptoms for at least 4 weeks
2. Examination reveals diffuse pain with provocative maneuvers
3. Impingement symptoms with or without a partial thickness tear (if available MRI study must be less than 50% tear)
4. Willingness to participate in an investigational technique
5. Willingness to forgo any other concomitant conservative treatment modality including NSAID (must be stopped for at least one week)

Exclusion Criteria:

1. Previous rotator cuff repair
2. Complete rotator cuff tear or two tendon tears
3. Pt w/ complex regional pain syndrome
4. Cervical neuropathy or other nerve pathology
5. RA, local or systemic infection, PVD, metabolic disease such as gout, clotting disorder, anticoagulation therapy
6. Evidence of intraarticular arthritis
7. Work related or compensable injury
8. Previous treatment: corticosteroid injection in the last 6 months
9. Patients who are currently pregnant

Primary outcomes:
measure: Pain and Disability of the Shoulder Through Validated Questionnaires
timeFrame: 6 weeks from initial injection of corticosteroid versus platelet rich plasma
measure: Pain and Disability of the Shoulder Through Validated Questionnaires
timeFrame: 12 weeks from initial injection of corticosteroid versus platelet rich plasma
measure: Pain and Disability of the Shoulder Through Validated Questionnaires
timeFrame: 15 minutes prior to initial injection of corticosteroid versus platelet rich plasma
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University Department of Orthopedics
name: Montri D Wongworawat, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fukuda H. The management of partial-thickness tears of the rotator cuff. J Bone Joint Surg Br. 2003 Jan;85(1):3-11. doi: 10.1302/0301-620x.85b1.13846. No abstract available.
citation: Blair B, Rokito AS, Cuomo F, Jarolem K, Zuckerman JD. Efficacy of injections of corticosteroids for subacromial impingement syndrome. J Bone Joint Surg Am. 1996 Nov;78(11):1685-9. doi: 10.2106/00004623-199611000-00007.
citation: Mishra A, Pavelko T. Treatment of chronic elbow tendinosis with buffered platelet-rich plasma. Am J Sports Med. 2006 Nov;34(11):1774-8. doi: 10.1177/0363546506288850. Epub 2006 May 30.
citation: Buchbinder R, Green S, Youd JM. Corticosteroid injections for shoulder pain. Cochrane Database Syst Rev. 2003;2003(1):CD004016. doi: 10.1002/14651858.CD004016.