A Prospective Comparison of Ultrasound-Guided Percutaneous Platelet-Rich Plasma Injection - Full Text View

Purpose

The purpose of this study is to determine the effectiveness of various treatment soft tendinosis also known as tendinitis.

Condition	Intervention
Tendinosis Tendinitis	Procedure: Tenotomy Drug: Ultrasound guided percutaneous platelet rich plasma injection

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Prospective Comparison of Ultrasound-Guided Percutaneous Platelet-Rich Plasma Injection Versus Tenotomy for Treatment of Gluteus Minimus and Medius Tendinosis

Further study details as provided by University of Michigan:

Primary Outcome Measures:

Tenotomy [ Time Frame: 30 days ] [ Designated as safety issue: No ]
An evaluation and assessment of subject's pain and symptoms will be completed prior to treatment. After receiving medication a second evaluation will be taken to determine how well the medication has relieved and controlled the subject's pain and inflammation associated with tendinitis.

Subjects will be specifically asked to rate the level of pain and how the pain is effecting common activities of daily living. The outcomes will be assessed at 1 and 2 weeks, and then following their progress via clinic notes.

Secondary Outcome Measures:

Effectiveness of the PRP (platelet rich plasma) injection. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Evaluation of PRP(platelet rich plasma) injection treatment and pain assessment versus Tenotomy group. Subject's who receive the platlet rich plasma injections will be evaluated prior to the injection to determine what the level of pain they are currently experiencing. The subjects will be questioned and evaluated at 15 and 30 day intervals to determine the effectiveness of the injection in controlling the pain/discomfort and inflammatory symptoms associated with tendinitis.

Estimated Enrollment:	30
Study Start Date:	July 2010
Estimated Study Completion Date:	August 2014
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Tenotomy Group Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.	Procedure: Tenotomy Subjects randomized to this group will sign a treatment consent and complete a pretreatment pain assessment survey which should take approximately 15 min. to complete. Subjects will also have blood drawn from one of the veins in their arm. Follow-up by principal investigator who will contact the subject by telephone or email which subject prefers, on day 14 and day 30 to complete the pain assessment survey questionnaire. Subjects will be asked to without any non steroidal anti inflammatory medications for 2 weeks prior to enrollment. 2 weeks after enrollment in study, subjects will see their referring physician to begin physical therapy.
Active Comparator: PRP Injection group Treatment is an ultrasound guided percutaneous injection of platelet-rich plasma injection.	Drug: Ultrasound guided percutaneous platelet rich plasma injection Subjects will have an ultrasound performed; will have blood drawn from a vein in the arm. The blood that is drawn will be spun in a centrifuge. Spinning the blood will separate the blood cells from the fluid in your blood. The fluid will rise to the top of the tube; this fluid is called plasma. The plasma will then be used for injection into the tendon. Under sterile conditions the subject will be given a local anesthetic called lidocaine. A pain assessment survey will be completed before the procedure. The primary investigator will also contact the subject via telephone or by email on day 14 and day 30 to complete the pain assessment questionnaire. Subject will be asked to withhold any non steroidal anti inflammatory medications for 2 weeks prior to enrollment in the study and for two weeks after enrollment unless other medical conditions require their use. Subjects will also be asked to see their referring physician two weeks after treatment to begin physical therapy.

Arms

Assigned Interventions

Active Comparator: Tenotomy Group

Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.

Procedure: Tenotomy

Subjects randomized to this group will sign a treatment consent and complete a pretreatment pain assessment survey which should take approximately 15 min. to complete. Subjects will also have blood drawn from one of the veins in their arm. Follow-up by principal investigator who will contact the subject by telephone or email which subject prefers, on day 14 and day 30 to complete the pain assessment survey questionnaire. Subjects will be asked to without any non steroidal anti inflammatory medications for 2 weeks prior to enrollment. 2 weeks after enrollment in study, subjects will see their referring physician to begin physical therapy.

Active Comparator: PRP Injection group

Treatment is an ultrasound guided percutaneous injection of platelet-rich plasma injection.

Drug: Ultrasound guided percutaneous platelet rich plasma injection

Subjects will have an ultrasound performed; will have blood drawn from a vein in the arm. The blood that is drawn will be spun in a centrifuge. Spinning the blood will separate the blood cells from the fluid in your blood. The fluid will rise to the top of the tube; this fluid is called plasma. The plasma will then be used for injection into the tendon. Under sterile conditions the subject will be given a local anesthetic called lidocaine. A pain assessment survey will be completed before the procedure. The primary investigator will also contact the subject via telephone or by email on day 14 and day 30 to complete the pain assessment questionnaire. Subject will be asked to withhold any non steroidal anti inflammatory medications for 2 weeks prior to enrollment in the study and for two weeks after enrollment unless other medical conditions require their use. Subjects will also be asked to see their referring physician two weeks after treatment to begin physical therapy.

Detailed Description:

Currently there are three treatments that are considered standard of care; rest, tenotomy and tenotomy with injections of platelet-rich plasma (PRP). Tenotomy is performed by passing a needle through the abnormal tendon repeatedly until the needle has passed through all areas of the abnormal tendon with softening of the tendon. Tenotomy with PRP injections is performed in the same manner but includes an injection of platelet-rich plasma (PRP) into the tendon. This study will evaluate the effectiveness of tenotomy versus PRP treatment.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult subjects with a diagnosis of tendinosis of the hip.
Adult subjects who have been referred to Dr. Jacobson for the treatment of tendinosis by tenotomy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01600326

Contacts

Contact: Jon Jacobson, M.D.

734-936-4365

jjacobsn@umich.edu

Locations

United States, Michigan
University of Michigan Hospital	Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jon Jacobson, M.D. 734-936-4365 jjacobsn@umich.edu

Sponsors and Collaborators

University of Michigan

Investigators

Principal Investigator:

Jon Jacobson, MD

University of Michigan Hospital

More Information

No publications provided

Responsible Party:	Jon Jacobson, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier:	NCT01600326 History of Changes
Other Study ID Numbers:	HUM00039445
Study First Received:	May 1, 2012
Last Updated:	November 7, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on June 17, 2013