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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001420 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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Although no single treatment has shown superiority, short-term pain relief may be offered via a targeted local corticosteroid injection (CSI), used often in combination with local anesthetic (LA), which may reduce plantar fasciitis symptoms for up to 1 month. Moreover, administering a CSI is relatively quick and easy for any Provider to perform, though it is not without potential deleterious side effects and risks, including fibroblast degradation, fat pad atrophy, skin depigmentation, and even plantar fascia rupture.
Research performed in other musculoskeletal disorders (e.g. lateral epicondylitis) suggest that the "method" (i.e peppering vs single bolus deposition) of injection is more favorable than the steroid itself, though evidence for this positive effect in plantar fasciitis is rather scarce.
Injection via peppering is a minimally invasive percutaneous technique which involves repeatedly fenestrating the pathologic site (i.e. plantar fascia) via hypodermic needle insertion at the tender area, then sequentially injecting a substance, withdrawing, redirecting, and reinserting all without emerging from the skin. Though hypothetical, this technique is thought to disrupt the degenerative process of Plantar Fasciitis (PF), encouraging both localized bleeding and fibroblastic proliferation and stimulating a local inflammatory response that would trigger the body's own reparative mechanism, leading to recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| corticosteroid injection/ local anesthetic (CSI/LA) | Experimental | The PI will then administer the (CSI/LA) injection using an infracalcaneal needle peppering technique as follows:
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| local anesthetic (LA)/Saline injection | Placebo Comparator | The PI will then administer the (LA/Saline) injection using an infracalcaneal needle peppering technique as follows:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corticosteroid injection (CSI) with local anesthetic (LA) | Drug | The PI will then administer the injection using an infracalcaneal needle peppering |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale Score - General Heel Tenderness | A sheet of paper with a printed VAS scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their general heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range 0-100. | Baseline |
| Visual Analog Scale Score - General Heel Tenderness | A sheet of paper with a printed visual analog score scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their general heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100. | Week 2 |
| Visual Analog Scale Score - General Heel Tenderness | A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their general heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range 0-100. | Week 4 |
| Visual Analog Scale Score - General Heel Tenderness | A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their general heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100. | Week 8 |
| Visual Analog Scale Score - General Heel Tenderness |
| Measure | Description | Time Frame |
|---|---|---|
| Exit Survey Score | Upon completion of study related procedures and assessments, participants will be given a paper exit survey to complete. 5 questions asked relating to their experience in the study and if they would recommend the study to others. Total score range 1-10 with 1 being worst experience and 10 being best experience. | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael A Jones, DPM | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Corticosteroid Injection/ Local Anesthetic (CSI/LA) | The PI will then administer the (CSI/LA) injection using an infracalcaneal needle peppering technique as follows:
Corticosteroid injection (CSI) with local anesthetic (LA): The PI will then administer the injection using an infracalcaneal needle peppering |
| FG001 | Local Anesthetic (LA)/Saline Injection | The PI will then administer the (LA/Saline) injection using an infracalcaneal needle peppering technique as follows:
Local anesthetic (LA) with Saline injection: The PI will then administer the injection using an infracalcaneal needle peppering |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Corticosteroid Injection/ Local Anesthetic (CSI/LA) | The PI will then administer the (CSI/LA) injection using an infracalcaneal needle peppering technique as follows:
Corticosteroid injection (CSI) with local anesthetic (LA): The PI will then administer the injection using an infracalcaneal needle peppering |
| 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, Continuous | Mean |
| 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 | Visual Analog Scale Score - General Heel Tenderness | A sheet of paper with a printed VAS scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their general heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range 0-100. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
Baseline through Week 12
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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 | Corticosteroid Injection/ Local Anesthetic (CSI/LA) | The PI will then administer the (CSI/LA) injection using an infracalcaneal needle peppering technique as follows:
Corticosteroid injection (CSI) with local anesthetic (LA): The PI will then administer the injection using an infracalcaneal needle peppering |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Jones, DPM | Atrium Health Wake Forest Baptist | 704-355-2000 | michael.jones4@advocatehealth.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 | Apr 5, 2024 | Sep 2, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 3, 2024 | Aug 28, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D036981 | Fasciitis, Plantar |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D061888 | Craniospinal Irradiation |
| D000779 | Anesthetics, Local |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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All patients ages 18 years and up with a diagnosis of plantar heel pain will be screened for inclusion into the study.
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A nurse or staff member will open a previously prepared and sealed opaque envelope (prepared beforehand by the clinical coordinator) labeled with the participant identification (ID) of the patient, which will be unique to the individual and different from their Medical Record Number (MRN). In this envelope, they will discover the patient's assigned treatment arm. The nurse or staff member will then prepare the syringe with the assigned treatment arm. Once the syringe is filled with the designated substance, the syringe will be wrapped with opaque tape or dark Coban wrap to conceal the contents in the syringe for both the PI and study participant.
|
| Local anesthetic (LA) with Saline injection | Drug | The PI will then administer the injection using an infracalcaneal needle peppering |
|
|
A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their general heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100. |
| Week 12 |
| Visual Analog Scale Score - First Step Pain | A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their first step heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100. | Baseline |
| Visual Analog Scale Score - First Step Pain | A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their first step heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100. | Week 2 |
| Visual Analog Scale Score - First Step Pain | A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their first step heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100. | Week 4 |
| Visual Analog Scale Score - First Step Pain | A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their first step heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100. | Week 8 |
| Visual Analog Scale Score - First Step Pain | A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their first step heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100. | Week 12 |
| Foot Function Index (FFI) Score | Questionnaire that measures pain, activity limitation, and disability in the foot. The FFI consists of 23 items grouped into three subscales: (1) Pain (9 items); (2) Disability (9 items); and (3) Activity Limitation (5 items). Each item is rated on a scale from 0-9 for the Pain and Disability subscales and 0-5 for the Activity Limitation subscale. For each subscale, scores are summed, divided by the maximum possible total for applicable items (excluding any marked "not applicable"), and multiplied by 100 to yield a percentage score from 0 to 100. Lower FFI scores indicate better foot function, while higher FFI scores reflect greater impairment. | Baseline |
| Foot Function Index (FFI) Score | Questionnaire that measures pain, activity limitation, and disability in the foot. The FFI consists of 23 items grouped into three subscales: (1) Pain (9 items); (2) Disability (9 items); and (3) Activity Limitation (5 items). Each item is rated on a scale from 0-9 for the Pain and Disability subscales and 0-5 for the Activity Limitation subscale. For each subscale, scores are summed, divided by the maximum possible total for applicable items (excluding any marked "not applicable"), and multiplied by 100 to yield a percentage score from 0 to 100. Lower FFI scores indicate better foot function, while higher FFI scores reflect greater impairment. | Week 2 |
| Foot Function Index (FFI) Score | Questionnaire that measures pain, activity limitation, and disability in the foot. The FFI consists of 23 items grouped into three subscales: (1) Pain (9 items); (2) Disability (9 items); and (3) Activity Limitation (5 items). Each item is rated on a scale from 0-9 for the Pain and Disability subscales and 0-5 for the Activity Limitation subscale. For each subscale, scores are summed, divided by the maximum possible total for applicable items (excluding any marked "not applicable"), and multiplied by 100 to yield a percentage score from 0 to 100. Lower FFI scores indicate better foot function, while higher FFI scores reflect greater impairment. | Week 4 |
| Foot Function Index (FFI) Score | Questionnaire that measures pain, activity limitation, and disability in the foot. The FFI consists of 23 items grouped into three subscales: (1) Pain (9 items); (2) Disability (9 items); and (3) Activity Limitation (5 items). Each item is rated on a scale from 0-9 for the Pain and Disability subscales and 0-5 for the Activity Limitation subscale. For each subscale, scores are summed, divided by the maximum possible total for applicable items (excluding any marked "not applicable"), and multiplied by 100 to yield a percentage score from 0 to 100. Lower FFI scores indicate better foot function, while higher FFI scores reflect greater impairment. | Week 8 |
| Foot Function Index (FFI) Score | Questionnaire that measures pain, activity limitation, and disability in the foot. The FFI consists of 23 items grouped into three subscales: (1) Pain (9 items); (2) Disability (9 items); and (3) Activity Limitation (5 items). Each item is rated on a scale from 0-9 for the Pain and Disability subscales and 0-5 for the Activity Limitation subscale. For each subscale, scores are summed, divided by the maximum possible total for applicable items (excluding any marked "not applicable"), and multiplied by 100 to yield a percentage score from 0 to 100. Lower FFI scores indicate better foot function, while higher FFI scores reflect greater impairment. | Week 12 |
| Number of Completed Exercises |
Participants will document in a daily exercise diary if any of the three recommended exercises (calf stretching, plantar fascia specific stretching, and loading exercise) were completed. Participants will also be asked to document why exercises were not completed if applicable. |
| Week 2, Week 4, Week 8, and Week 12 |
| Heel Pressure Threshold Score - Symptomatic Foot | Using a dolorimeter each participant's heel pressure threshold will be assessed. Level of pain on a 35-point scale will be noted with 0 meaning no pain and 35 meaning extreme pain. | Baseline, Week 2, Week 4, Week 8, and Week 12 |
| Heel Pressure Threshold Score - Asymptomatic Foot | Using a dolorimeter each participant's heel pressure threshold will be assessed. Level of pain on a 35-point scale will be noted with 0 meaning no pain and 35 meaning extreme pain. | Baseline, Week 2, Week 4, Week 8, Week 12 |
| Heel Tenderness Score - Symptomatic Foot | The physician will assess heel pain on palpation. Heel tenderness index will be used which has a range of 0-3 points (0 points = no pain, 1 point = painful, 2 points = painful and winces, 3 points = painful, winces, and withdraws). | Baseline, Week 2, Week 4, Week 8, and Week 12 |
| Heel Tenderness Score - Asymptomatic Foot | The physician will assess heel pain on palpation. Heel tenderness index will be used which has a range of 0-3 points (0 points = no pain, 1 point = painful, 2 points = painful and winces, 3 points = painful, winces, and withdraws). | Baseline, week 2, week 4, week 8, week 12 |
| BG001 | Local Anesthetic (LA)/Saline Injection | The PI will then administer the (LA/Saline) injection using an infracalcaneal needle peppering technique as follows:
Local anesthetic (LA) with Saline injection: The PI will then administer the injection using an infracalcaneal needle peppering |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Diabetes Mellitus Diagnosis | Number | participants |
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| Clinical Duration of Symptoms | Mean | Standard Deviation | days |
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| Plantar Fascia Thickness | Mean | Standard Deviation | mm |
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| Heel Spur Size | Mean | Standard Deviation | mm |
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| Patients Diagnosed with Heel Spur | Number | participants |
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| OG001 | Local Anesthetic (LA)/Saline Injection | The PI will then administer the (LA/Saline) injection using an infracalcaneal needle peppering technique as follows:
Local anesthetic (LA) with Saline injection: The PI will then administer the injection using an infracalcaneal needle peppering |
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| Primary | Visual Analog Scale Score - General Heel Tenderness | A sheet of paper with a printed visual analog score scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their general heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100. | For CSI/LA arm, 2 participants did not complete the study, 2 participant missed Week 2 appointment. For LA/saline arm, 2 participants missed Week 2 appointment, 1 participant did not complete the study, 2 missing data. | Posted | Mean | Standard Deviation | score on a scale | Week 2 |
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| Primary | Visual Analog Scale Score - General Heel Tenderness | A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their general heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range 0-100. | For CSI/LA arm, 2 participant missed Week 4 appointment, 2 participants did not complete the study 1 missing data. For LA/saline arm, 3 missed appointment, 1 participants did not complete the study. | Posted | Mean | Standard Deviation | score on a scale | Week 4 |
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| Primary | Visual Analog Scale Score - General Heel Tenderness | A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their general heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100. | For the CSI.LA arm, 4 participants did not complete the study, 1 participant did not have this data point collected at Week 8 appointment, and 3 participants missed Week 8 appointment. For the LA/saline arm, 4 patients did not complete the study | Posted | Mean | Standard Deviation | score on a scale | Week 8 |
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| Primary | Visual Analog Scale Score - General Heel Tenderness | A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their general heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100. | For CSI/LA arm, 5 participants did not complete the study. For LA/saline arm, 4 patients did not complete the study, and 1 patient missed Week 12 appointment | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Primary | Visual Analog Scale Score - First Step Pain | A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their first step heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Primary | Visual Analog Scale Score - First Step Pain | A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their first step heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100. | For the CSI/LA arm, 2 participants did not complete the study, 2 person missed Week 2 appointment. For LA/saline arm, 2 participants missed Week 2 appointment, 1 participant did not complete study. | Posted | Mean | Standard Deviation | score on a scale | Week 2 |
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| Primary | Visual Analog Scale Score - First Step Pain | A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their first step heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100. | For the CSI/LA arm, 2 participants missed Week 4 appointment, 2 participants did not complete study. For LA/saline injection arm, 3 participants did not complete the study. | Posted | Mean | Standard Deviation | score on a scale | Week 4 |
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| Primary | Visual Analog Scale Score - First Step Pain | A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their first step heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100. | For the CSI/LA arm, 4 participants did not complete the study, 3 participants missed Week 8 appointment. For the LA/saline arm, 1 participant did not have this data point collected, 4 participants did not complete the study. | Posted | Mean | Standard Deviation | score on a scale | Week 8 |
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| Primary | Visual Analog Scale Score - First Step Pain | A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their first step heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100. | For the CSI/LA arm, 5 participants did not complete study. For the LA/saline arm, 4 participants did not complete the study, 1 participant missed Week 12 appointment. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Primary | Foot Function Index (FFI) Score | Questionnaire that measures pain, activity limitation, and disability in the foot. The FFI consists of 23 items grouped into three subscales: (1) Pain (9 items); (2) Disability (9 items); and (3) Activity Limitation (5 items). Each item is rated on a scale from 0-9 for the Pain and Disability subscales and 0-5 for the Activity Limitation subscale. For each subscale, scores are summed, divided by the maximum possible total for applicable items (excluding any marked "not applicable"), and multiplied by 100 to yield a percentage score from 0 to 100. Lower FFI scores indicate better foot function, while higher FFI scores reflect greater impairment. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Primary | Foot Function Index (FFI) Score | Questionnaire that measures pain, activity limitation, and disability in the foot. The FFI consists of 23 items grouped into three subscales: (1) Pain (9 items); (2) Disability (9 items); and (3) Activity Limitation (5 items). Each item is rated on a scale from 0-9 for the Pain and Disability subscales and 0-5 for the Activity Limitation subscale. For each subscale, scores are summed, divided by the maximum possible total for applicable items (excluding any marked "not applicable"), and multiplied by 100 to yield a percentage score from 0 to 100. Lower FFI scores indicate better foot function, while higher FFI scores reflect greater impairment. | For the CSI/LA arm, 2 participants did not complete study, 1 missed appointment. For LA/saline arm, 1 participant missed Week 2 appointment, 1 participant did not complete study. | Posted | Mean | Standard Deviation | score on a scale | Week 2 |
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| Primary | Foot Function Index (FFI) Score | Questionnaire that measures pain, activity limitation, and disability in the foot. The FFI consists of 23 items grouped into three subscales: (1) Pain (9 items); (2) Disability (9 items); and (3) Activity Limitation (5 items). Each item is rated on a scale from 0-9 for the Pain and Disability subscales and 0-5 for the Activity Limitation subscale. For each subscale, scores are summed, divided by the maximum possible total for applicable items (excluding any marked "not applicable"), and multiplied by 100 to yield a percentage score from 0 to 100. Lower FFI scores indicate better foot function, while higher FFI scores reflect greater impairment. | For CSI/LA arm, 1 participant missed Week 4 appointment, 2 participants did not complete study. For the LA/saline arm, 3 participants did not complete study. | Posted | Mean | Standard Deviation | score on a scale | Week 4 |
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| Primary | Foot Function Index (FFI) Score | Questionnaire that measures pain, activity limitation, and disability in the foot. The FFI consists of 23 items grouped into three subscales: (1) Pain (9 items); (2) Disability (9 items); and (3) Activity Limitation (5 items). Each item is rated on a scale from 0-9 for the Pain and Disability subscales and 0-5 for the Activity Limitation subscale. For each subscale, scores are summed, divided by the maximum possible total for applicable items (excluding any marked "not applicable"), and multiplied by 100 to yield a percentage score from 0 to 100. Lower FFI scores indicate better foot function, while higher FFI scores reflect greater impairment. | For the CSI/LA arm, 3 participants missed Week 8 appointment, 4 participants did not finish study. For the LA/saline arm, 4 participants did not finish study. | Posted | Mean | Standard Deviation | score on a scale | Week 8 |
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| Primary | Foot Function Index (FFI) Score | Questionnaire that measures pain, activity limitation, and disability in the foot. The FFI consists of 23 items grouped into three subscales: (1) Pain (9 items); (2) Disability (9 items); and (3) Activity Limitation (5 items). Each item is rated on a scale from 0-9 for the Pain and Disability subscales and 0-5 for the Activity Limitation subscale. For each subscale, scores are summed, divided by the maximum possible total for applicable items (excluding any marked "not applicable"), and multiplied by 100 to yield a percentage score from 0 to 100. Lower FFI scores indicate better foot function, while higher FFI scores reflect greater impairment. | For the CSI/LA arm, 5 participants did not complete study. For the LA/saline arm, 5 participants did not complete study. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Secondary | Exit Survey Score | Upon completion of study related procedures and assessments, participants will be given a paper exit survey to complete. 5 questions asked relating to their experience in the study and if they would recommend the study to others. Total score range 1-10 with 1 being worst experience and 10 being best experience. | For the CSI/LA arm, 5 participants did not complete the study, 1 missing data. For the LA/saline arm, 5 did not complete the study. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Secondary | Number of Completed Exercises | Participants will document in a daily exercise diary if any of the three recommended exercises (calf stretching, plantar fascia specific stretching, and loading exercise) were completed. Participants will also be asked to document why exercises were not completed if applicable. | W2: CSI/LA 2 didn't complete study, 2 missed appt, 3 no diary; LA/saline 1 didn't complete study, 1 missed appt, 2 no diary. W4: CSI/LA 3 no diary, 1 missed appt, 2 didn't complete study; LA/saline 3 no diary, 3 didn't complete study. W8: CSI/LA, 1 no diary, 4 didn't complete study, 3 missed appt; LA/saline 4 didn't finish study, 1 no diary. W12: CSI/LA 5 no diary, 5 didn't finish study; LA/saline 4 no diary, 5 didn't complete study. | Posted | Mean | Standard Deviation | exercises completed | Week 2, Week 4, Week 8, and Week 12 |
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| Secondary | Heel Pressure Threshold Score - Symptomatic Foot | Using a dolorimeter each participant's heel pressure threshold will be assessed. Level of pain on a 35-point scale will be noted with 0 meaning no pain and 35 meaning extreme pain. | Baseline: CSI/LA 1 outlier, data excluded. W2: CSI/LA 2 didn't complete study, 2 missed appt; LA/saline 1 didn't complete study, 3 missed appt. W4: CSI/LA 2 missed appt, 2 didn't complete study; LA/saline 3 didn't complete study. W8: CSI/LA 4 didn't complete study, 5 missed appt; LA/saline 4 didn't finish study, 1 missing data, 2 outliers data excluded. W12: CSI/LA 5 didn't finish study, 1 missing data; LA/saline 5 didn't complete study, 1 missing data, 2 outliers. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 2, Week 4, Week 8, and Week 12 |
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| Secondary | Heel Pressure Threshold Score - Asymptomatic Foot | Using a dolorimeter each participant's heel pressure threshold will be assessed. Level of pain on a 35-point scale will be noted with 0 meaning no pain and 35 meaning extreme pain. | BL:CSI/LA 1 outlier data excluded; LS/saline 3 outliers. W2:CSI/LA 2 didn't complete study, 2 missed appt; LA/saline 1 didn't complete study, 3 missed appt, 2 outliers. W4:CSI/LA 2 missed appt, 2 didn't complete study; LA/saline 3 didn't complete study, 3 outliers. W8:CSI/LA 4 didn't complete study, 5 missed appt; LA/saline 4 didn't finish study, 1 missing data, 4 outliers. W12:CSI/LA 5 didn't finish study, 1 missing; LA/saline 5 didn't complete study, 1 missed appt, 4 outliers. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 2, Week 4, Week 8, Week 12 |
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| Secondary | Heel Tenderness Score - Symptomatic Foot | The physician will assess heel pain on palpation. Heel tenderness index will be used which has a range of 0-3 points (0 points = no pain, 1 point = painful, 2 points = painful and winces, 3 points = painful, winces, and withdraws). | WK 2: CSI/LA 2 missed appt, 2 did not complete study; LA/saline 3 missed appt, 1 did not complete study. WK 4: CSI/LA 2 missed appt, 2 did not finish study; LA/saline 3 did not finish study. WK 8: CSI/LA 5 missed appt, 4 did not finish study; LA/saline 4 did not finish study, 1 missed appt. WK 12: CSI/LA 1 missed data, 5 did not finish study; LA/saline 5 did not finish study, 1 missing data. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 2, Week 4, Week 8, and Week 12 |
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| Secondary | Heel Tenderness Score - Asymptomatic Foot | The physician will assess heel pain on palpation. Heel tenderness index will be used which has a range of 0-3 points (0 points = no pain, 1 point = painful, 2 points = painful and winces, 3 points = painful, winces, and withdraws). | Baseline: CSI/LA 2 missing data; LA/saline 2 missing data. WK 2: CSI/LA 2 missed appt, 2 did not complete study; LA/saline 1 did not complete study, 3 missed appt, 2 missing data. WK 4: CSI/LA 2 missed appt, 2 did not finish study; LA/saline 3 did not finish study. WK 8: CSI/LA 5 missed appt, 4 did not finish study; LA/saline 4 did not finish study, 1 missed appointment. WK 12: CSI/LA 1 missed data, 5 did not finish study; LA/saline 1 missing data, 5 did not finish study. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 2, week 4, week 8, week 12 |
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| 0 |
| 21 |
| 0 |
| 21 |
| 2 |
| 21 |
| EG001 | Local Anesthetic (LA)/Saline Injection | The PI will then administer the (LA/Saline) injection using an infracalcaneal needle peppering technique as follows:
Local anesthetic (LA) with Saline injection: The PI will then administer the injection using an infracalcaneal needle peppering | 0 | 20 | 0 | 20 | 2 | 20 |
| oral surgery | General disorders | Systematic Assessment |
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| mass with sensation | General disorders | Systematic Assessment |
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Not provided
Not provided
Not provided
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
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