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Completed

NCT Number: NCT01600326

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

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

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Key information

Conditions

Tendinosis Muscular Diseases Musculoskeletal Diseases Tendinitis Tendinopathy Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tenotomy (no injection)

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.

Ultrasound guided platelet rich plasma injection

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.

Primary outcomes

  1. Pain Level and Interference With Activity

    Time frame: Up to 23 days

    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).

Secondary outcomes

  1. Number of Participants Showing Symptomatic Improvement as Assessed in Patient Chart

    Time frame: 15 to 555 days post treatment

    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).

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
May 17, 2012
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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