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

NCT ID: NCT01600326

Last Updated: 2017-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2015-07-31

Brief Summary

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

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.

Conditions

Tendinosis; Tendinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tenotomy Group

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

Group Type: ACTIVE_COMPARATOR

Tenotomy (no injection)

Intervention Type: PROCEDURE

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.

Plasma Injection Group

Treatment is Ultrasound guided platelet rich plasma injection.

Group Type: ACTIVE_COMPARATOR

Ultrasound guided platelet rich plasma injection

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Eligibility 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Jon Jacobson

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jon Jacobson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Hospital

Locations

University of Michigan Hospital

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00039445

Identifier Type: -

Identifier Source: org_study_id