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

Tendinosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600326
• Other study ID #: HUM00039445
• Status: Completed
• Phase: N/A
• First received: May 1, 2012
• Last updated: December 21, 2016
• Start date: July 2010
• Est. completion date: July 2015

Study information

• Verified date: December 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tendinitis
• Tendinopathy
• Tendinosis

Intervention

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 14 and day 30 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.

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 14 and day 30 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.

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	McMaster University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tenotomy	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.	30 days	No
Secondary	Effectiveness of the PRP (platelet rich plasma) injection.	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.	30 days	No