Ice House, Carleton University
Sport Medicine & Physiotherapy:
Sport Med: (613) 520-3510
Medical Team of:
Dr. Taryn Taylor, Faculty & Principal Investigator
Dr. Ryan Shields, collaborator
Brigitte Roy, Research Assistant
Purpose: The purpose of this comparison study is to:
1) To investigate the use of ACP as treatment for labral tears compared to corticosteroid injection
2) Determine the proportion of patients willing to be randomized, the outcome and cost measures to determine which outcome measures to use, the recruitment and retention rates; and to estimate the levels of outcome variability to calculate sample sizes for the main study.
Task requirements: We are asking you to be a research participant in this study. On your second visit, you will be required to have blood taken from a vein in your arm and then either receive one injection of either ACP or corticosteroid into your affected hip by one of Drs. Taylor, Bradley, or Sheridan. You will then complete 4 follow-up visits over a 12-month period in which you will see a physician, complete a questionnaire (iHOT-33) about your symptoms and ability to perform daily activities, and your analgesic (painkiller) use.
At your injection visit, after the skin surface of your inner elbow is thoroughly cleaned with either chlorhexidine or alcohol swabs, a needle is inserted to withdraw approximately 15ml of blood. This may be performed under ultrasound guidance if necessary. If you are randomized to receive ACP, this blood will be spun down in a centrifuge and the plasma portion will be injected into your affected hip joint. The syringe contents will be concealed in order to blind you to which treatment you are receiving.
You will then be required to lie on your back with your upper leg/groin exposed. An ultrasound machine will be used to visualize the hip joint. The area will be cleaned with either chlorhexidine or alcohol swabs. The hip joint will be entered with a needle attached to a syringe containing either ACP or CS.
Benefits/compensation: You may have improved hip pain and function after injection. You will not receive any compensation for participating in this research. Researchers are not receiving any compensation.
Potential risk/discomfort: Potential adverse events include vasovagal reaction (<10%), post-injection flare (2-10%), rash from alcohol or chlorhexidine, bruising at the site of injection, bleeding at the skin or within the joint, joint pain or stiffness, cartilage damage, blood vessel damage, nerve damage, parasthesias (tingling sensation), bursitis, and tendonitis. Potential adverse events specific to the intra-articular steroid injections include steroid arthropathy (0.8%), tendon rupture, and hypersensitivity reaction (<1%). The most serious adverse reaction is infection (
Some of these risks are decreased by using ultrasound guidance. Some individuals might feel uncomfortable when asked to how they are coping with their symptoms and with how it is affecting their day to day activities. If you feel any discomfort or distress, you may choose not to answer specific questions, and you will not be penalized in any way if you do this.
Adverse Events: The occurrence of the risks as described above will be monitored and you will be notified if any unforeseen events occur during the study. If it is found that one treatment is significantly more harmful or beneficial than the other, the study will be terminated.
Anonymity/Confidentiality: The data collected in this study are strictly confidential. All data are coded such that your name is not associated with the responses you provide. Any identifying information associated with your code will be confined to a single page that will be separated from your questionnaire, and kept in a separate, secured file by the research investigators, who will keep this information confidential. The informed consent and all other identifying information will be destroyed after three years. The anonymously coded data will be kept and will be used for research and teaching purposes.
Right to withdraw: Your participation in this study is entirely voluntary. If you choose not to participate in the study, this will not impact the quality of care which is provided to you. At any point during the study, you have the right to withdraw, be informed which injection you received and request that your data be deleted. If you would like the alternate injection performed then we will be provided this if desired, however the cost this injection will not be covered.
Debriefing: At your final visit you will be told which injection you received, at your discretion.
This study has received clearance by Carleton University Research Ethics Board-B
(Protocol #16-063). Date of ethics clearance expiration is March 2017.
Should you have any ethical concerns with the study, please contact Dr. Andy Adler (Chair, Carleton University Research Ethics Board-B (by phone: 613-520-2600 ext. 4085 or email: firstname.lastname@example.org).
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Keep checking back for the final report.