Treatment of the Rotator Cuff Disease With Platelet Rich Plasma Injection

NCT01123889 | Completed Results

• 1 other identifier: 59322
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Subacromial Impingement Syndrome; Partial Thickness Rotator Cuff Tear

Keywords

subacromial impingement; partial thickness rotator cuff; PRP; platelet rich plasma

Outcome Measures

Primary Outcomes (3)

• Pain and Disability of the Shoulder Through Validated Questionnaires

  Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function.

  6 weeks from initial injection of corticosteroid versus platelet rich plasma

• Pain and Disability of the Shoulder Through Validated Questionnaires

  Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function.

  12 weeks from initial injection of corticosteroid versus platelet rich plasma

• Pain and Disability of the Shoulder Through Validated Questionnaires

  Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function.

  15 minutes prior to initial injection of corticosteroid versus platelet rich plasma

Study Arms (2)

control

ACTIVE COMPARATOR

corticosteroid injection into subacromial space

Drug: corticosteroid injection

experimental

EXPERIMENTAL

patients will receive an injection of platelet rich plasma into the subacromial space

Biological: platelet rich plasma injection

Interventions

platelet rich plasma injection BIOLOGICAL

45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions.

Also known as: platelet rich plasma - PRP, naropin, xylocaine

experimental

corticosteroid injection DRUG

Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions.

Also known as: triamcinalone, naropin, xylocaine

control

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University

Loma Linda, California, 92354, United States

Location

Related Publications (4)

• 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.

  PMID: 12585570 BACKGROUND

• 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.

  PMID: 8934482 BACKGROUND

• 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.

  PMID: 16735582 BACKGROUND

• Buchbinder R, Green S, Youd JM. Corticosteroid injections for shoulder pain. Cochrane Database Syst Rev. 2003;2003(1):CD004016. doi: 10.1002/14651858.CD004016.

  PMID: 12535501 BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Ropivacaine; Lidocaine; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Liz Clarke
• Organization: Loma Linda University Orthopaedic Surgery

eaclarke@llu.edu

909-558-5592

Study Officials

• Montri D Wongworawat, MD

  Loma Linda University Department of Orthopedics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: May 14, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: February 11, 2014
• Results First Posted: February 11, 2014

Record last verified: 2013-12

Locations

US (1)