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

A Prospective Comparison of Ultrasound-Guided Percutaneous Platelet-Rich Plasma Injection Versus Tenotomy for Treatment of Gluteus Minimus and Medius Tendinosis

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

Study Overview

• Status: Completed
• Conditions: Tendinosis; Tendinitis
• Intervention / Treatment: Procedure: Tenotomy (no injection); Drug: Ultrasound guided platelet rich plasma injection

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Exclusion Criteria:

• pregnancy
• risk of bleeding due to anticoagulant medication
• presence of malignancy
• steroid injection less than 3 months before enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 (no injection); Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy.
Active Comparator: Plasma Injection Group; Treatment is Ultrasound guided platelet rich plasma injection.	Drug: Ultrasound guided platelet rich plasma injection; Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm. The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called "Ultrasound guided platelet rich plasma injection." Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study. Subjects will see their referring physician two weeks after treatment to begin physical therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Level and Interference With Activity	Patient symptoms are measured on a 50 point scale where 0 is no pain or interference with activities and 50 is highest pain and interference. A verbal 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 affecting common activities of daily living. The outcomes will be assessed at 2 follow up periods, 1 and approximately 2 weeks after treatment (but no more than 23 days).	Up to 23 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Showing Symptomatic Improvement as Assessed in Patient Chart	Information from patient charts were retrospectively reviewed to determine if symptoms were reported as improved, worse, or no change over a time period (range 15 to 555 days post treatment).	15 to 555 days post treatment

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Jon Jacobson, MD, University of Michigan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2010
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: May 1, 2012
• First Submitted That Met QC Criteria: May 16, 2012
• First Posted (Estimate): May 17, 2012

Study Record Updates

• Last Update Posted (Actual): April 5, 2017
• Last Update Submitted That Met QC Criteria: February 20, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: HUM00039445

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No