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| ID | Type | Description | Link |
|---|---|---|---|
| A539300 | Other Identifier | UW Madison | |
| SMPH/RADIOLOGY/RADIOLOGY* | Other Identifier | UW Madison | |
| Protocol Ver 0.15, 12/23/2021 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| General Electric | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet-Rich Plasma (PRP) | Experimental | Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous PRP. |
|
| Dry Needling Procedure | Placebo Comparator | Group 2 (dry needling) will undergo US-guided dry needling procedure similar to PRP injection. |
|
| Sham Procedure | Sham Comparator | Group 3 (sham) will undergo US-guided sham dry needling procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP | Biological | Injection of autologous platelet rich plasma (PRP) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 16 weeks, 32 weeks, 52 weeks |
| 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. | baseline, 16 weeks, 32 weeks, 52 weeks |
| 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). | baseline, 16 weeks, 32 weeks, 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 16 weeks, 52 weeks |
| MRI Scan To Demonstrate Treatment-related Changes in Pathologic Imaging Features of PT (Thickness) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 16 weeks, 52 weeks |
| Relationship Between Changes in Novel Quantitative MRI and US Parameters of PT and Clinical and Biomechanical Improvement Following Treatment. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Lee, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin, Madison | Madison | Wisconsin | 53705 | United States |
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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 were recruited from April 2017 to June 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | Dry Needling Procedure |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, 16 weeks, 32 weeks, 52 weeks |
|
up to 52 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Lee, MD, MBA | University of Wisconsin School of Medicine and Public Health | (608) 263-9387 | klee2@uwhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 23, 2021 | Aug 14, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000079245 | Dry Needling |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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Double-blinded randomized controlled trial
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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.
| Dry Needling |
| Procedure |
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. |
|
| Dry Needling - Sham | Procedure | 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. |
|
To demonstrate treatment-related changes in pathologic imaging features of PT using conventional MRI measures. |
| baseline, 16 weeks, 52 weeks |
| 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. | baseline, 16 weeks, 52 weeks |
| 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. | baseline, 16 weeks, 52 weeks |
| 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. | baseline, 16 weeks, 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. |
| 52 weeks |
| Ultrashort Time to Echo (UTE) T2* Relaxation Time (T2*Single) | Exploratory MRI measure | baseline, 16 weeks, 52 weeks |
| T2* Fraction of Fast-relaxing Macromolecular-bound Water (FF) | baseline, 16 weeks, 52 weeks |
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.
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG002 | 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. |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, 16 weeks, 32 weeks, 52 weeks |
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | baseline, 16 weeks, 32 weeks, 52 weeks |
|
|
|
| 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. | 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. | Posted | baseline, 16 weeks, 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. | MRI was not used to measure thickness, Ultrasound was used to assess thickness. | Posted | baseline, 16 weeks, 52 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | millimeters | baseline, 16 weeks, 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, 16 weeks, 52 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, 16 weeks, 52 weeks |
|
|
|
| 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. | Not Posted | baseline, 16 weeks, 52 weeks | Participants |
| 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. | Not Posted | 52 weeks | Participants |
| Other Pre-specified | Ultrashort Time to Echo (UTE) T2* Relaxation Time (T2*Single) | Exploratory MRI measure | Not Posted | baseline, 16 weeks, 52 weeks | Participants |
| Other Pre-specified | T2* Fraction of Fast-relaxing Macromolecular-bound Water (FF) | Not Posted | baseline, 16 weeks, 52 weeks | Participants |
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | 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. | 0 | 9 | 0 | 9 | 0 | 9 |
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| 32 weeks |
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| 52 weeks |
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| 32 weeks |
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| 52 weeks |
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| 52 weeks |
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| Change from Baseline at 52 weeks |
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| Change from Baseline at 52 weeks |
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