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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jon Jacobson, University of Michigan
ClinicalTrials.gov Identifier:
NCT01600326
First received: May 1, 2012
Last updated: February 20, 2017
Last verified: February 2017
  Purpose
The purpose of this study is to determine the effectiveness of various treatment soft tendinosis also known as tendinitis.

Condition Intervention Phase
Tendinosis
Tendinitis
Procedure: Tenotomy (no injection)
Drug: Ultrasound guided platelet rich plasma injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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).


Enrollment: 30
Actual Study Start Date: July 2010
Study Completion Date: July 2015
Primary Completion Date: July 2015 (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 (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.


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   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Exclusion Criteria:

  • pregnancy
  • risk of bleeding due to anticoagulant medication
  • presence of malignancy
  • steroid injection less than 3 months before enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Jon Jacobson, MD University of Michigan Hospital
  More Information

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
Results First Received: February 20, 2017
Last Updated: February 20, 2017
Individual Participant Data  
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 24, 2017