Patellar Tendinitis
Conditions
Brief summary
The overall goal of this research is to find an effective treatment for patellar tendinopathy (PT). To achieve this, we will conduct a double-blinded randomized controlled trial to investigate if platelet-rich plasma is effective for treatment. Clinical (pain and function scores) and bio-mechanical (knee strength) measures will be correlated with disease modification changes assessed using conventional and novel quantitative magnetic resonance imaging (MRI) and ultrasound (US) techniques.
Detailed description
Sixty-six patients with PT will be randomized to one of three study arms. Subjects in Group 1 (PRP) will receive a single US-guided injection of 5 milliliters of autologous PRP into the patellar tendon, subjects in Group 2 (DN) will undergo ultrasound guided dry needling of the patellar tendon, and subjects in Group 3 (SH) will undergo a sham control ultrasound guided dry needling in the subcutaneous tissue only (not intratendon) at the level of the patellar tendon. The efficacy of the different treatment options will be assessed by pain- and function-dependent, PT-specific Victorian Institute of Sport Assessment Patella (VISA-P) quality of life scores, activity level scores, knee strength measurements, and conventional and novel MRI and US imaging at baseline, 16, 32, and 52 weeks post-treatment.
Interventions
BIOLOGICALPRP
Injection of autologous platelet rich plasma (PRP)
PROCEDUREDry Needling
This is a therapeutic procedure that involves the same injection procedures under ultrasound guidance as in the PRP group but no PRP will be injected inside the patellar tendon.
PROCEDUREDry Needling - Sham
This is a sham procedure that involves similar injection procedures under ultrasound guidance as in the PRP and DN groups with no injection of PRP or needle placement inside the patellar tendon.
Sponsors
General Electric
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Subjects and assessors will be blinded to the subject group allocation. Subjects will be identified to study personnel using a unique study number only and results of the imaging studies will be blinded, batched, and evaluated in a randomized manner.
Intervention model description
Double-blinded randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 39 years 2. Chronic (\>3 months) PT 3. Clinical examination consistent with PT 4. MRI or US confirmation of PT 5. Pain score of 3 or greater on a 10-point visual analogue scale 6. Self-report failure of supervised physical therapy 7. Self-report failure of at least 2 of the most common treatment options for PT (e.g. NSAIDs, relative rest, ice and bracing).
Exclusion criteria
1. Inability to comply with study follow-up requirements 2. History of bleeding disorders or other hematologic conditions 3. Knee pain from other possible etiologies (e.g., degenerative joint disease, meniscal tear, ligament injury or reconstruction) 4. Full or partial patellar tendon tear 5. Current use of anticoagulation or immunosuppressive therapy 6. Prior knee trauma requiring medical attention or surgery 7. Worker's compensation injury 8. Daily opioid use for pain 9. Contraindication to MRI. 10. Systemic diseases such as Diabetes and connective tissue diseases. 11. Prior PRP or DN procedure. 12. Women that are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Measure of Pain Level: VISA-P Score | baseline, 16 weeks, 32 weeks, 52 weeks | A quality of life measure, the Victoria Institute of Sport Assessment - Patellar Tendon (VISA-P) will be used to evaluate pain before and after the intervention. The instrument is scored from 0-100 with higher scores indicating less pain. |
| Change in Visual Analogue Scale (VAS) Pain Score | baseline, 16 weeks, 32 weeks, 52 weeks | Participant pain level was assessed using a VAS score from 0 (no pain) to 10 (worst pain). |
| Change in Measure of Activity Level: Tegner Activity Level Score | baseline, 16 weeks, 32 weeks, 52 weeks | The Tegner Activity Level Score will be used to evaluate activity level before and after the intervention. It is scored from 0-10 with 0 indicating disability and 10 competitive elite sport. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness) | baseline, 16 weeks, 52 weeks | To demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures. |
| MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (T2 Signal Intensity) | baseline, 16 weeks, 52 weeks | To demonstrate treatment-related changes in pathologic imaging features of PT using conventional MRI measures. |
| MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness) | baseline, 16 weeks, 52 weeks | To demonstrate treatment-related changes in pathologic imaging features of PT using conventional MRI measures. |
| Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline | baseline, 16 weeks, 52 weeks | To demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures. Echogenicity is the grey scale images found on standard B-mode exams. The grey scale can change with pathology, therefore, the grading scale is implemented. The data reported are scores from a grading system, where 0 - normal; 1- mild; 2- moderate; 3- severe. |
| Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline | baseline, 16 weeks, 52 weeks | To demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures. Hyperemia means an increase in the number of blood vessels, it is scored on a semi-qualitative scale where 0 - normal; 1- mild; 2- moderate; 3- severe. If there's an improvement in hyperemia grading then the score decreases. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Relationship Between Changes in Novel Quantitative MRI and US Parameters of PT and Clinical and Biomechanical Improvement Following Treatment. | 52 weeks | To investigate the relationship between changes in novel quantitative MRI techniques and US parameters of PT and clinical and biomechanical improvement following treatment. |
| T2* Fraction of Fast-relaxing Macromolecular-bound Water (FF) | baseline, 16 weeks, 52 weeks | — |
| Isokinetic Dynamometer Measure of Flexor and Extensor Muscle Strength Before and After the Intervention | baseline, 16 weeks, 52 weeks | Flexor and extensor muscle strength will be measured with this device before and after the intervention. |
| Ultrashort Time to Echo (UTE) T2* Relaxation Time (T2*Single) | baseline, 16 weeks, 52 weeks | Exploratory MRI measure |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from April 2017 to June 2021.
Pre-assignment details
One person was consented and enrolled to the study, but post-imaging analysis, did not have patellar tendinopathy and did not fully onboard to study.
Participants by arm
| Arm | Count |
|---|---|
| Platelet-Rich Plasma (PRP) Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP.
PRP: Injection of autologous platelet rich plasma (PRP) | 10 |
| Dry Needling Procedure Group 2 (dry needling) will undergo US-guided dry needling procedure similar to PRP injection.
Dry Needling: This is a therapeutic procedure that involves the same injection procedures under ultrasound guidance as in the PRP group but no PRP will be injected inside the patellar tendon. | 10 |
| Sham Procedure Group 3 (sham) will undergo US-guided sham dry needling procedure.
Dry Needling - Sham: This is a sham procedure that involves similar injection procedures under ultrasound guidance as in the PRP and DN groups with no injection of PRP or needle placement inside the patellar tendon. | 9 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Platelet-Rich Plasma (PRP) | Dry Needling Procedure | Sham Procedure | Total |
|---|---|---|---|---|
| Age, Customized 20-29 years old | 7 Participants | 6 Participants | 7 Participants | 20 Participants |
| Age, Customized 30-39 years old | 3 Participants | 4 Participants | 2 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 10 Participants | 8 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 8 Participants | 10 Participants | 6 Participants | 24 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 9 participants | 29 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 7 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 9 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 9 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 9 |
Outcome results
Primary
Change in Measure of Activity Level: Tegner Activity Level Score
The Tegner Activity Level Score will be used to evaluate activity level before and after the intervention. It is scored from 0-10 with 0 indicating disability and 10 competitive elite sport.
Time frame: baseline, 16 weeks, 32 weeks, 52 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Platelet-Rich Plasma (PRP) | Change in Measure of Activity Level: Tegner Activity Level Score | 52 weeks | 4.8 score on a scale | Standard Deviation 7.3 |
| Platelet-Rich Plasma (PRP) | Change in Measure of Activity Level: Tegner Activity Level Score | 16 weeks | 3.5 score on a scale | Standard Deviation 6 |
| Platelet-Rich Plasma (PRP) | Change in Measure of Activity Level: Tegner Activity Level Score | 32 weeks | 4.2 score on a scale | Standard Deviation 6.7 |
| Platelet-Rich Plasma (PRP) | Change in Measure of Activity Level: Tegner Activity Level Score | baseline | 2.8 score on a scale | Standard Deviation 5.2 |
| Dry Needling Procedure | Change in Measure of Activity Level: Tegner Activity Level Score | 16 weeks | 4.5 score on a scale | Standard Deviation 6.9 |
| Dry Needling Procedure | Change in Measure of Activity Level: Tegner Activity Level Score | baseline | 5 score on a scale | Standard Deviation 7.2 |
| Dry Needling Procedure | Change in Measure of Activity Level: Tegner Activity Level Score | 32 weeks | 5.1 score on a scale | Standard Deviation 7.5 |
| Dry Needling Procedure | Change in Measure of Activity Level: Tegner Activity Level Score | 52 weeks | 5.2 score on a scale | Standard Deviation 7.9 |
| Sham Procedure | Change in Measure of Activity Level: Tegner Activity Level Score | 32 weeks | 4.5 score on a scale | Standard Deviation 7 |
| Sham Procedure | Change in Measure of Activity Level: Tegner Activity Level Score | 16 weeks | 4.6 score on a scale | Standard Deviation 7.1 |
| Sham Procedure | Change in Measure of Activity Level: Tegner Activity Level Score | baseline | 5.3 score on a scale | Standard Deviation 7.8 |
| Sham Procedure | Change in Measure of Activity Level: Tegner Activity Level Score | 52 weeks | 4.5 score on a scale | Standard Deviation 7 |
Primary
Change in Measure of Pain Level: VISA-P Score
A quality of life measure, the Victoria Institute of Sport Assessment - Patellar Tendon (VISA-P) will be used to evaluate pain before and after the intervention. The instrument is scored from 0-100 with higher scores indicating less pain.
Time frame: baseline, 16 weeks, 32 weeks, 52 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Platelet-Rich Plasma (PRP) | Change in Measure of Pain Level: VISA-P Score | baseline | 32.2 score on a scale | Standard Deviation 57.8 |
| Platelet-Rich Plasma (PRP) | Change in Measure of Pain Level: VISA-P Score | 16 weeks | 52.5 score on a scale | Standard Deviation 78.1 |
| Platelet-Rich Plasma (PRP) | Change in Measure of Pain Level: VISA-P Score | 32 weeks | 62.1 score on a scale | Standard Deviation 87.7 |
| Platelet-Rich Plasma (PRP) | Change in Measure of Pain Level: VISA-P Score | 52 weeks | 64 score on a scale | Standard Deviation 89.6 |
| Dry Needling Procedure | Change in Measure of Pain Level: VISA-P Score | 52 weeks | 55.6 score on a scale | Standard Deviation 83 |
| Dry Needling Procedure | Change in Measure of Pain Level: VISA-P Score | baseline | 46.3 score on a scale | Standard Deviation 69.5 |
| Dry Needling Procedure | Change in Measure of Pain Level: VISA-P Score | 32 weeks | 56.2 score on a scale | Standard Deviation 81.3 |
| Dry Needling Procedure | Change in Measure of Pain Level: VISA-P Score | 16 weeks | 56.9 score on a scale | Standard Deviation 82 |
| Sham Procedure | Change in Measure of Pain Level: VISA-P Score | 52 weeks | 60.3 score on a scale | Standard Deviation 87 |
| Sham Procedure | Change in Measure of Pain Level: VISA-P Score | 16 weeks | 53.7 score on a scale | Standard Deviation 79.4 |
| Sham Procedure | Change in Measure of Pain Level: VISA-P Score | 32 weeks | 58.9 score on a scale | Standard Deviation 85.7 |
| Sham Procedure | Change in Measure of Pain Level: VISA-P Score | baseline | 43.2 score on a scale | Standard Deviation 68.8 |
Primary
Change in Visual Analogue Scale (VAS) Pain Score
Participant pain level was assessed using a VAS score from 0 (no pain) to 10 (worst pain).
Time frame: baseline, 16 weeks, 32 weeks, 52 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Platelet-Rich Plasma (PRP) | Change in Visual Analogue Scale (VAS) Pain Score | 16 weeks | 2.5 score on a scale | Standard Deviation 5.6 |
| Platelet-Rich Plasma (PRP) | Change in Visual Analogue Scale (VAS) Pain Score | baseline | 5.9 score on a scale | Standard Deviation 9 |
| Platelet-Rich Plasma (PRP) | Change in Visual Analogue Scale (VAS) Pain Score | 32 weeks | 1.1 score on a scale | Standard Deviation 4.1 |
| Platelet-Rich Plasma (PRP) | Change in Visual Analogue Scale (VAS) Pain Score | 52 weeks | 0 score on a scale | Standard Deviation 3.2 |
| Dry Needling Procedure | Change in Visual Analogue Scale (VAS) Pain Score | 52 weeks | 2.8 score on a scale | Standard Deviation 6.1 |
| Dry Needling Procedure | Change in Visual Analogue Scale (VAS) Pain Score | 16 weeks | 4.2 score on a scale | Standard Deviation 7.2 |
| Dry Needling Procedure | Change in Visual Analogue Scale (VAS) Pain Score | 32 weeks | 3.8 score on a scale | Standard Deviation 6.8 |
| Dry Needling Procedure | Change in Visual Analogue Scale (VAS) Pain Score | baseline | 5.5 score on a scale | Standard Deviation 8.3 |
| Sham Procedure | Change in Visual Analogue Scale (VAS) Pain Score | 32 weeks | 1.6 score on a scale | Standard Deviation 4.7 |
| Sham Procedure | Change in Visual Analogue Scale (VAS) Pain Score | 16 weeks | 2.9 score on a scale | Standard Deviation 6 |
| Sham Procedure | Change in Visual Analogue Scale (VAS) Pain Score | baseline | 6.1 score on a scale | Standard Deviation 9.2 |
| Sham Procedure | Change in Visual Analogue Scale (VAS) Pain Score | 52 weeks | 1.8 score on a scale | Standard Deviation 4.9 |
Secondary
MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (T2 Signal Intensity)
To demonstrate treatment-related changes in pathologic imaging features of PT using conventional MRI measures.
Time frame: baseline, 16 weeks, 52 weeks
Population: T2 signal intensity was not measured via MRI, rather MRI was used for exploratory measures using novel software as updated in the Other Pre-specified measures.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (T2 Signal Intensity) | baseline | — |
| Unknown | MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (T2 Signal Intensity) | 16 weeks | — |
| Unknown | MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (T2 Signal Intensity) | 52 weeks | — |
Secondary
MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness)
To demonstrate treatment-related changes in pathologic imaging features of PT using conventional MRI measures.
Time frame: baseline, 16 weeks, 52 weeks
Population: MRI was not used to measure thickness, Ultrasound was used to assess thickness.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness) | baseline | — |
| Unknown | MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness) | 16 weeks | — |
| Unknown | MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness) | 52 weeks | — |
Secondary
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline
To demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures. Echogenicity is the grey scale images found on standard B-mode exams. The grey scale can change with pathology, therefore, the grading scale is implemented. The data reported are scores from a grading system, where 0 - normal; 1- mild; 2- moderate; 3- severe.
Time frame: baseline, 16 weeks, 52 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Platelet-Rich Plasma (PRP) | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline | Change from Baseline at 16 weeks | 1.3 score on a scale | Standard Deviation 2.5 |
| Platelet-Rich Plasma (PRP) | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline | baseline | 1.3 score on a scale | Standard Deviation 2.5 |
| Platelet-Rich Plasma (PRP) | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline | Change from Baseline at 52 weeks | 1.3 score on a scale | Standard Deviation 2.5 |
| Dry Needling Procedure | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline | baseline | 1.5 score on a scale | Standard Deviation 2.5 |
| Dry Needling Procedure | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline | Change from Baseline at 16 weeks | 1.3 score on a scale | Standard Deviation 2.4 |
| Dry Needling Procedure | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline | Change from Baseline at 52 weeks | 1.4 score on a scale | Standard Deviation 2.6 |
| Sham Procedure | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline | baseline | 1.4 score on a scale | Standard Deviation 2.6 |
| Sham Procedure | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline | Change from Baseline at 52 weeks | 1.1 score on a scale | Standard Deviation 2.3 |
| Sham Procedure | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Echogenicity) From Baseline | Change from Baseline at 16 weeks | 1.9 score on a scale | Standard Deviation 3 |
Secondary
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline
To demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures. Hyperemia means an increase in the number of blood vessels, it is scored on a semi-qualitative scale where 0 - normal; 1- mild; 2- moderate; 3- severe. If there's an improvement in hyperemia grading then the score decreases.
Time frame: baseline, 16 weeks, 52 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Platelet-Rich Plasma (PRP) | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline | Change from Baseline at 16 weeks | 0.7 score on a scale | Standard Deviation 2 |
| Platelet-Rich Plasma (PRP) | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline | baseline | 1.1 score on a scale | Standard Deviation 2.5 |
| Platelet-Rich Plasma (PRP) | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline | Change from Baseline at 52 weeks | 0.4 score on a scale | Standard Deviation 1.8 |
| Dry Needling Procedure | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline | Change from Baseline at 16 weeks | 0.4 score on a scale | Standard Deviation 1.7 |
| Dry Needling Procedure | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline | baseline | 0.6 score on a scale | Standard Deviation 1.8 |
| Dry Needling Procedure | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline | Change from Baseline at 52 weeks | -0.2 score on a scale | Standard Deviation 1.2 |
| Sham Procedure | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline | baseline | 1.4 score on a scale | Standard Deviation 2.8 |
| Sham Procedure | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline | Change from Baseline at 52 weeks | 0.4 score on a scale | Standard Deviation 1.8 |
| Sham Procedure | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Hyperemia) From Baseline | Change from Baseline at 16 weeks | 1.3 score on a scale | Standard Deviation 2.7 |
Secondary
Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness)
To demonstrate treatment-related changes in pathologic imaging features of PT using conventional ultrasound measures.
Time frame: baseline, 16 weeks, 52 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Platelet-Rich Plasma (PRP) | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness) | 16 weeks | 6.5 millimeters | Standard Deviation 8.5 |
| Platelet-Rich Plasma (PRP) | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness) | baseline | 6.6 millimeters | Standard Deviation 8.6 |
| Platelet-Rich Plasma (PRP) | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness) | 52 weeks | 6 millimeters | Standard Deviation 8 |
| Dry Needling Procedure | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness) | 16 weeks | 5.4 millimeters | Standard Deviation 7.3 |
| Dry Needling Procedure | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness) | baseline | 5.2 millimeters | Standard Deviation 7.1 |
| Dry Needling Procedure | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness) | 52 weeks | 5.4 millimeters | Standard Deviation 7.4 |
| Sham Procedure | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness) | baseline | 7 millimeters | Standard Deviation 9 |
| Sham Procedure | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness) | 52 weeks | 5.7 millimeters | Standard Deviation 7.7 |
| Sham Procedure | Ultrasound Scan to Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness) | 16 weeks | 7 millimeters | Standard Deviation 9.1 |
Other Pre-specified
Isokinetic Dynamometer Measure of Flexor and Extensor Muscle Strength Before and After the Intervention
Flexor and extensor muscle strength will be measured with this device before and after the intervention.
Time frame: baseline, 16 weeks, 52 weeks
Other Pre-specified
Relationship Between Changes in Novel Quantitative MRI and US Parameters of PT and Clinical and Biomechanical Improvement Following Treatment.
To investigate the relationship between changes in novel quantitative MRI techniques and US parameters of PT and clinical and biomechanical improvement following treatment.
Time frame: 52 weeks
Other Pre-specified
T2* Fraction of Fast-relaxing Macromolecular-bound Water (FF)
Time frame: baseline, 16 weeks, 52 weeks
Other Pre-specified
Ultrashort Time to Echo (UTE) T2* Relaxation Time (T2*Single)
Exploratory MRI measure
Time frame: baseline, 16 weeks, 52 weeks