Chronic Plantar Fasciitis
Conditions
Keywords
corticosteroid injection, infracalcaneal peppering injection, Plantar Fasciitis
Brief summary
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.
Detailed description
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.
Interventions
DRUGCorticosteroid injection (CSI) with local anesthetic (LA)
The PI will then administer the injection using an infracalcaneal needle peppering
DRUGLocal anesthetic (LA) with Saline injection
The PI will then administer the injection using an infracalcaneal needle peppering
Sponsors
National Center for Advancing Translational Sciences (NCATS)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
All patients ages 18 years and up with a diagnosis of plantar heel pain will be screened for inclusion into the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women 18 years of age and older * Patient reported history of plantar heel pain and confirmed clinical tenderness of pain with direct palpation of the medial calcaneal tubercle on baseline exam * Diagnosis of chronic plantar fasciitis, defined for study purposes as symptoms greater than or equal to 6 weeks in duration
Exclusion criteria
* Individuals less than 18 years of age * Pregnancy * History of receiving a local heel injection (i.e. corticosteroid injection (CSI) or other injectate) within the last 3 months * Prior heel trauma or surgery * Allergy to local corticosteroid or local anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale Score - General Heel Tenderness | Baseline | 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. |
| Visual Analog Scale Score - First Step Pain | Baseline | 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. |
| Foot Function Index (FFI) Score | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heel Pressure Threshold Score - Asymptomatic Foot | Baseline, Week 2, Week 4, Week 8, Week 12 | 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. |
| Exit Survey Score | Week 12 | 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. |
| Heel Tenderness Score - Asymptomatic Foot | Baseline, week 2, week 4, week 8, week 12 | 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). |
| Heel Tenderness Score - Symptomatic Foot | Baseline, Week 2, Week 4, Week 8, and Week 12 | 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). |
| Number of Completed Exercises | Week 2, Week 4, Week 8, and Week 12 | 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. |
| Heel Pressure Threshold Score - Symptomatic Foot | Baseline, Week 2, Week 4, Week 8, and Week 12 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) The PI will then administer the (CSI/LA) injection using an infracalcaneal needle peppering technique as follows:
1. The hypodermic needle is inserted using infracalcaneal injection approach.
2. The hypodermic needle is withdrawn while at the same depositing injectate
3. The hypodermic needle is redirected without emerging from the skin. The PI will perform steps 1-3 standardly 20-25 times.
Corticosteroid injection (CSI) with local anesthetic (LA): The PI will then administer the injection using an infracalcaneal needle peppering | 21 |
| Local Anesthetic (LA)/Saline Injection The PI will then administer the (LA/Saline) injection using an infracalcaneal needle peppering technique as follows:
1. The hypodermic needle is inserted using infracalcaneal injection approach.
2. The hypodermic needle is withdrawn while at the same depositing injectate
3. The hypodermic needle is redirected without emerging from the skin. The PI will perform steps 1-3 standardly 20-25 times.
Local anesthetic (LA) with Saline injection: The PI will then administer the injection using an infracalcaneal needle peppering | 20 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 5 |
Baseline characteristics
| Characteristic | Local Anesthetic (LA)/Saline Injection | Total | Corticosteroid Injection/ Local Anesthetic (CSI/LA) |
|---|---|---|---|
| Age, Continuous | 53.5 years STANDARD_DEVIATION 13.1 | 54 years STANDARD_DEVIATION 12 | 54 years STANDARD_DEVIATION 12.4 |
| Clinical Duration of Symptoms | 125 days STANDARD_DEVIATION 217 | 166 days STANDARD_DEVIATION 272.5 | 205 days STANDARD_DEVIATION 323 |
| Diabetes Mellitus Diagnosis | 1 participants | 5 participants | 4 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 38 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Heel Spur Size | 5.1 mm STANDARD_DEVIATION 3.9 | 5.1 mm STANDARD_DEVIATION 3.5 | 5.1 mm STANDARD_DEVIATION 3.3 |
| Patients Diagnosed with Heel Spur | 15 participants | 31 participants | 16 participants |
| Plantar Fascia Thickness | 5.2 mm STANDARD_DEVIATION 2.8 | 5.2 mm STANDARD_DEVIATION 1.4 | 5.1 mm STANDARD_DEVIATION 1.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 16 Participants | 35 Participants | 19 Participants |
| Sex: Female, Male Female | 15 Participants | 36 Participants | 21 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 20 |
| other Total, other adverse events | 2 / 21 | 2 / 20 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 |
Outcome results
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Foot Function Index (FFI) Score | 42.4 score on a scale | Standard Deviation 13.5 |
| Local Anesthetic (LA)/Saline Injection | Foot Function Index (FFI) Score | 43.5 score on a scale | Standard Deviation 15.2 |
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.
Time frame: Week 2
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Foot Function Index (FFI) Score | 28.3 score on a scale | Standard Deviation 16.6 |
| Local Anesthetic (LA)/Saline Injection | Foot Function Index (FFI) Score | 33.1 score on a scale | Standard Deviation 15.5 |
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.
Time frame: Week 4
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Foot Function Index (FFI) Score | 22.2 score on a scale | Standard Deviation 16.9 |
| Local Anesthetic (LA)/Saline Injection | Foot Function Index (FFI) Score | 25.3 score on a scale | Standard Deviation 18.8 |
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.
Time frame: Week 8
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Foot Function Index (FFI) Score | 22.6 score on a scale | Standard Deviation 20.2 |
| Local Anesthetic (LA)/Saline Injection | Foot Function Index (FFI) Score | 17.1 score on a scale | Standard Deviation 17.2 |
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.
Time frame: Week 12
Population: For the CSI/LA arm, 5 participants did not complete study. For the LA/saline arm, 5 participants did not complete study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Foot Function Index (FFI) Score | 26.5 score on a scale | Standard Deviation 23.3 |
| Local Anesthetic (LA)/Saline Injection | Foot Function Index (FFI) Score | 18.6 score on a scale | Standard Deviation 20.2 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Visual Analog Scale Score - First Step Pain | 62.6 score on a scale | Standard Deviation 20.2 |
| Local Anesthetic (LA)/Saline Injection | Visual Analog Scale Score - First Step Pain | 70.6 score on a scale | Standard Deviation 15.3 |
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.
Time frame: Week 2
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Visual Analog Scale Score - First Step Pain | 40.4 score on a scale | Standard Deviation 26.3 |
| Local Anesthetic (LA)/Saline Injection | Visual Analog Scale Score - First Step Pain | 50.6 score on a scale | Standard Deviation 23.1 |
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.
Time frame: Week 4
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Visual Analog Scale Score - First Step Pain | 40.3 score on a scale | Standard Deviation 27.9 |
| Local Anesthetic (LA)/Saline Injection | Visual Analog Scale Score - First Step Pain | 37.8 score on a scale | Standard Deviation 23.6 |
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.
Time frame: Week 8
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Visual Analog Scale Score - First Step Pain | 38.7 score on a scale | Standard Deviation 32.7 |
| Local Anesthetic (LA)/Saline Injection | Visual Analog Scale Score - First Step Pain | 24.9 score on a scale | Standard Deviation 23 |
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.
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Visual Analog Scale Score - First Step Pain | 37.1 score on a scale | Standard Deviation 29.8 |
| Local Anesthetic (LA)/Saline Injection | Visual Analog Scale Score - First Step Pain | 22.9 score on a scale | Standard Deviation 22.6 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Visual Analog Scale Score - General Heel Tenderness | 46.7 score on a scale | Standard Deviation 19.3 |
| Local Anesthetic (LA)/Saline Injection | Visual Analog Scale Score - General Heel Tenderness | 47.5 score on a scale | Standard Deviation 17.7 |
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.
Time frame: Week 2
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Visual Analog Scale Score - General Heel Tenderness | 35.9 score on a scale | Standard Deviation 23.1 |
| Local Anesthetic (LA)/Saline Injection | Visual Analog Scale Score - General Heel Tenderness | 41.8 score on a scale | Standard Deviation 20.3 |
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.
Time frame: Week 4
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Visual Analog Scale Score - General Heel Tenderness | 36.6 score on a scale | Standard Deviation 25.6 |
| Local Anesthetic (LA)/Saline Injection | Visual Analog Scale Score - General Heel Tenderness | 32.6 score on a scale | Standard Deviation 21.8 |
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.
Time frame: Week 8
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Visual Analog Scale Score - General Heel Tenderness | 29.3 score on a scale | Standard Deviation 30.8 |
| Local Anesthetic (LA)/Saline Injection | Visual Analog Scale Score - General Heel Tenderness | 22.6 score on a scale | Standard Deviation 19.6 |
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.
Time frame: Week 12
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Visual Analog Scale Score - General Heel Tenderness | 31.4 score on a scale | Standard Deviation 25.3 |
| Local Anesthetic (LA)/Saline Injection | Visual Analog Scale Score - General Heel Tenderness | 24.4 score on a scale | Standard Deviation 23.7 |
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.
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Exit Survey Score | 8.8 score on a scale | Standard Deviation 1.8 |
| Local Anesthetic (LA)/Saline Injection | Exit Survey Score | 9.6 score on a scale | Standard Deviation 0.7 |
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.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Heel Pressure Threshold Score - Asymptomatic Foot | week 2 | 15.7 score on a scale | Standard Deviation 7.7 |
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Heel Pressure Threshold Score - Asymptomatic Foot | week 8 | 15.6 score on a scale | Standard Deviation 6.8 |
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Heel Pressure Threshold Score - Asymptomatic Foot | week 4 | 14.5 score on a scale | Standard Deviation 5.3 |
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Heel Pressure Threshold Score - Asymptomatic Foot | week 12 | 14.4 score on a scale | Standard Deviation 6.1 |
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Heel Pressure Threshold Score - Asymptomatic Foot | baseline | 16.0 score on a scale | Standard Deviation 6.5 |
| Local Anesthetic (LA)/Saline Injection | Heel Pressure Threshold Score - Asymptomatic Foot | week 12 | 15.2 score on a scale | Standard Deviation 5.9 |
| Local Anesthetic (LA)/Saline Injection | Heel Pressure Threshold Score - Asymptomatic Foot | baseline | 18.0 score on a scale | Standard Deviation 11.5 |
| Local Anesthetic (LA)/Saline Injection | Heel Pressure Threshold Score - Asymptomatic Foot | week 2 | 19.2 score on a scale | Standard Deviation 12.1 |
| Local Anesthetic (LA)/Saline Injection | Heel Pressure Threshold Score - Asymptomatic Foot | week 4 | 17.1 score on a scale | Standard Deviation 8.7 |
| Local Anesthetic (LA)/Saline Injection | Heel Pressure Threshold Score - Asymptomatic Foot | week 8 | 15.4 score on a scale | Standard Deviation 5.4 |
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.
Time frame: Baseline, Week 2, Week 4, Week 8, and Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Heel Pressure Threshold Score - Symptomatic Foot | week 2 | 12.6 score on a scale | Standard Deviation 6.8 |
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Heel Pressure Threshold Score - Symptomatic Foot | week 8 | 13.4 score on a scale | Standard Deviation 6.8 |
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Heel Pressure Threshold Score - Symptomatic Foot | week 4 | 12.5 score on a scale | Standard Deviation 5.7 |
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Heel Pressure Threshold Score - Symptomatic Foot | week 12 | 12.8 score on a scale | Standard Deviation 7 |
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Heel Pressure Threshold Score - Symptomatic Foot | baseline | 12.3 score on a scale | Standard Deviation 7.2 |
| Local Anesthetic (LA)/Saline Injection | Heel Pressure Threshold Score - Symptomatic Foot | week 12 | 15.4 score on a scale | Standard Deviation 7.7 |
| Local Anesthetic (LA)/Saline Injection | Heel Pressure Threshold Score - Symptomatic Foot | baseline | 12.3 score on a scale | Standard Deviation 6.8 |
| Local Anesthetic (LA)/Saline Injection | Heel Pressure Threshold Score - Symptomatic Foot | week 2 | 12.8 score on a scale | Standard Deviation 6 |
| Local Anesthetic (LA)/Saline Injection | Heel Pressure Threshold Score - Symptomatic Foot | week 4 | 14.1 score on a scale | Standard Deviation 5.9 |
| Local Anesthetic (LA)/Saline Injection | Heel Pressure Threshold Score - Symptomatic Foot | week 8 | 13.1 score on a scale | Standard Deviation 5.9 |
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).
Time frame: Baseline, week 2, week 4, week 8, week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Heel Tenderness Score - Asymptomatic Foot | week 2 | 0.18 score on a scale | Standard Deviation 0.38 |
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Heel Tenderness Score - Asymptomatic Foot | week 8 | 0 score on a scale | Standard Deviation 0 |
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Heel Tenderness Score - Asymptomatic Foot | week 4 | 0 score on a scale | Standard Deviation 0 |
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Heel Tenderness Score - Asymptomatic Foot | week 12 | 0.27 score on a scale | Standard Deviation 0.57 |
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Heel Tenderness Score - Asymptomatic Foot | baseline | 0.32 score on a scale | Standard Deviation 0.57 |
| Local Anesthetic (LA)/Saline Injection | Heel Tenderness Score - Asymptomatic Foot | week 12 | 0.21 score on a scale | Standard Deviation 0.77 |
| Local Anesthetic (LA)/Saline Injection | Heel Tenderness Score - Asymptomatic Foot | baseline | 0.33 score on a scale | Standard Deviation 0.58 |
| Local Anesthetic (LA)/Saline Injection | Heel Tenderness Score - Asymptomatic Foot | week 2 | 0.21 score on a scale | Standard Deviation 0.56 |
| Local Anesthetic (LA)/Saline Injection | Heel Tenderness Score - Asymptomatic Foot | week 4 | 0.12 score on a scale | Standard Deviation 0.47 |
| Local Anesthetic (LA)/Saline Injection | Heel Tenderness Score - Asymptomatic Foot | week 8 | 0.07 score on a scale | Standard Deviation 0.25 |
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).
Time frame: Baseline, Week 2, Week 4, Week 8, and Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Heel Tenderness Score - Symptomatic Foot | week 2 | 1.29 score on a scale | Standard Deviation 0.57 |
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Heel Tenderness Score - Symptomatic Foot | week 8 | 1.7 score on a scale | Standard Deviation 0.55 |
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Heel Tenderness Score - Symptomatic Foot | week 4 | 1.18 score on a scale | Standard Deviation 0.78 |
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Heel Tenderness Score - Symptomatic Foot | week 12 | 1.0 score on a scale | Standard Deviation 0.82 |
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Heel Tenderness Score - Symptomatic Foot | baseline | 1.95 score on a scale | Standard Deviation 0.65 |
| Local Anesthetic (LA)/Saline Injection | Heel Tenderness Score - Symptomatic Foot | week 12 | 1.0 score on a scale | Standard Deviation 1 |
| Local Anesthetic (LA)/Saline Injection | Heel Tenderness Score - Symptomatic Foot | baseline | 1.75 score on a scale | Standard Deviation 0.62 |
| Local Anesthetic (LA)/Saline Injection | Heel Tenderness Score - Symptomatic Foot | week 2 | 1.38 score on a scale | Standard Deviation 0.6 |
| Local Anesthetic (LA)/Saline Injection | Heel Tenderness Score - Symptomatic Foot | week 4 | 1.35 score on a scale | Standard Deviation 0.76 |
| Local Anesthetic (LA)/Saline Injection | Heel Tenderness Score - Symptomatic Foot | week 8 | 1.13 score on a scale | Standard Deviation 0.72 |
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.
Time frame: Week 2, Week 4, Week 8, and Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Number of Completed Exercises | week 2 | 14.1 exercises completed | Standard Deviation 3 |
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Number of Completed Exercises | week 4 | 13.8 exercises completed | Standard Deviation 2.7 |
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Number of Completed Exercises | week 8 | 26.2 exercises completed | Standard Deviation 4.9 |
| Corticosteroid Injection/ Local Anesthetic (CSI/LA) | Number of Completed Exercises | week 12 | 26.9 exercises completed | Standard Deviation 4.2 |
| Local Anesthetic (LA)/Saline Injection | Number of Completed Exercises | week 12 | 27.2 exercises completed | Standard Deviation 3.4 |
| Local Anesthetic (LA)/Saline Injection | Number of Completed Exercises | week 2 | 13.8 exercises completed | Standard Deviation 1.3 |
| Local Anesthetic (LA)/Saline Injection | Number of Completed Exercises | week 8 | 25.1 exercises completed | Standard Deviation 5.6 |
| Local Anesthetic (LA)/Saline Injection | Number of Completed Exercises | week 4 | 15.9 exercises completed | Standard Deviation 3.3 |