Tendinitis, Tendinosis
Conditions
Brief summary
The purpose of this study is to determine the effectiveness of various treatment soft tendinosis also known as tendinitis.
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.
Interventions
PROCEDURETenotomy (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.
DRUGUltrasound 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.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Level and Interference With Activity | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Showing Symptomatic Improvement as Assessed in Patient Chart | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Plasma Injection Group | Tenotomy Group |
|---|---|---|---|
| 50 Point Pain and Interfence with Activity scale | 31.9 units on a scale | 31.4 units on a scale | 32.4 units on a scale |
| Age, Continuous | 57 years | 53 years | 60 years |
| Region of Enrollment United States | 30 participants | 15 participants | 15 participants |
| Sex: Female, Male Female | 24 Participants | 14 Participants | 10 Participants |
| Sex: Female, Male Male | 6 Participants | 1 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 1 / 15 |
Outcome results
Primary
Pain Level and Interference With Activity
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).
Time frame: Up to 23 days
Population: One data point is missing for time point one for Plasma Injection Group, as noted below.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tenotomy Group | Pain Level and Interference With Activity | 2 wks post treatment ( no more than 23 days) | 15.2 units on a scale |
| Tenotomy Group | Pain Level and Interference With Activity | 1 week after treatment | 16.8 units on a scale |
| Plasma Injection Group | Pain Level and Interference With Activity | 1 week after treatment | 25.5 units on a scale |
| Plasma Injection Group | Pain Level and Interference With Activity | 2 wks post treatment ( no more than 23 days) | 19.4 units on a scale |
p-value: <0.0001Tukey
Comparison: One way repeated measure analysis of variance for outcome of total pain score over time adjusted for treatment with post hoc Tukey correction to adjust for multiple comparisonp-value: <0.0001Tukey
Secondary
Number of Participants Showing Symptomatic Improvement as Assessed in Patient Chart
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).
Time frame: 15 to 555 days post treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tenotomy Group | Number of Participants Showing Symptomatic Improvement as Assessed in Patient Chart | 10 Participants |
| Plasma Injection Group | Number of Participants Showing Symptomatic Improvement as Assessed in Patient Chart | 11 Participants |
p-value: >0.99Fisher Exact