Trial Outcomes & Findings for A Prospective Comparison of Ultrasound-Guided Percutaneous Platelet-Rich Plasma Injection (NCT NCT01600326)
NCT ID: NCT01600326
Last Updated: 2017-04-05
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Up to 23 days
Results posted on
2017-04-05
Participant Flow
Participant milestones
| Measure |
Tenotomy Group
Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.
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.
|
Plasma Injection Group
Treatment is Ultrasound guided platelet rich plasma injection.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
Primary Outcome Measure Data Collection
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Tenotomy Group
Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.
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.
|
Plasma Injection Group
Treatment is Ultrasound guided platelet rich plasma injection.
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
A Prospective Comparison of Ultrasound-Guided Percutaneous Platelet-Rich Plasma Injection
Baseline characteristics by cohort
| Measure |
Tenotomy Group
n=15 Participants
Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.
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.
|
Plasma Injection Group
n=15 Participants
Treatment is Ultrasound guided platelet rich plasma injection.
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.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=99 Participants
|
53 years
n=107 Participants
|
57 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
15 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
50 Point Pain and Interfence with Activity scale
|
32.4 units on a scale
n=99 Participants
|
31.4 units on a scale
n=107 Participants
|
31.9 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 23 daysPopulation: One data point is missing for time point one for Plasma Injection Group, as noted below.
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).
Outcome measures
| Measure |
Tenotomy Group
n=15 Participants
Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.
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.
|
Plasma Injection Group
n=15 Participants
Treatment is Ultrasound guided platelet rich plasma injection.
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.
|
|---|---|---|
|
Pain Level and Interference With Activity
1 week after treatment
|
16.8 units on a scale
Interval 0.0 to 34.0
|
25.5 units on a scale
Interval 9.0 to 41.0
|
|
Pain Level and Interference With Activity
2 wks post treatment ( no more than 23 days)
|
15.2 units on a scale
Interval 0.0 to 34.0
|
19.4 units on a scale
Interval 4.0 to 42.0
|
SECONDARY outcome
Timeframe: 15 to 555 days post treatmentInformation 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).
Outcome measures
| Measure |
Tenotomy Group
n=14 Participants
Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.
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.
|
Plasma Injection Group
n=14 Participants
Treatment is Ultrasound guided platelet rich plasma injection.
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.
|
|---|---|---|
|
Number of Participants Showing Symptomatic Improvement as Assessed in Patient Chart
|
10 Participants
|
11 Participants
|
Adverse Events
Tenotomy Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Plasma Injection Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tenotomy Group
n=15 participants at risk
Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.
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.
|
Plasma Injection Group
n=15 participants at risk
Treatment is Ultrasound guided platelet rich plasma injection.
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.
|
|---|---|---|
|
Infections and infestations
Fever
|
0.00%
0/15 • Two data collection points, the second of which is between 14 and 23 days following treatment
|
6.7%
1/15 • Two data collection points, the second of which is between 14 and 23 days following treatment
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place