Trial Outcomes & Findings for Infracalcaneal Peppering Injection Technique for Chronic Plantar Fasciitis (NCT NCT05868577)
NCT ID: NCT05868577
Last Updated: 2025-10-30
Results Overview
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.
COMPLETED
PHASE1
41 participants
Baseline
2025-10-30
Participant Flow
Participant milestones
| Measure |
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 The hypodermic needle is withdrawn while at the same depositing injectate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
|
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 The hypodermic needle is withdrawn while at the same depositing injectate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
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
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 The hypodermic needle is withdrawn while at the same depositing injectate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
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
Baseline Characteristics
Infracalcaneal Peppering Injection Technique for Chronic Plantar Fasciitis
Baseline characteristics by cohort
| Measure |
Corticosteroid Injection/ Local Anesthetic (CSI/LA)
n=21 Participants
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
|
Local Anesthetic (LA)/Saline Injection
n=20 Participants
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
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
53.5 years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
54 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Diabetes Mellitus Diagnosis
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Clinical Duration of Symptoms
|
205 days
STANDARD_DEVIATION 323 • n=5 Participants
|
125 days
STANDARD_DEVIATION 217 • n=7 Participants
|
166 days
STANDARD_DEVIATION 272.5 • n=5 Participants
|
|
Plantar Fascia Thickness
|
5.1 mm
STANDARD_DEVIATION 1.7 • n=5 Participants
|
5.2 mm
STANDARD_DEVIATION 2.8 • n=7 Participants
|
5.2 mm
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Heel Spur Size
|
5.1 mm
STANDARD_DEVIATION 3.3 • n=5 Participants
|
5.1 mm
STANDARD_DEVIATION 3.9 • n=7 Participants
|
5.1 mm
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
Patients Diagnosed with Heel Spur
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineA 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.
Outcome measures
| Measure |
Corticosteroid Injection/ Local Anesthetic (CSI/LA)
n=21 Participants
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
|
Local Anesthetic (LA)/Saline Injection
n=20 Participants
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
|
|---|---|---|
|
Visual Analog Scale Score - General Heel Tenderness
|
46.7 score on a scale
Standard Deviation 19.3
|
47.5 score on a scale
Standard Deviation 17.7
|
PRIMARY outcome
Timeframe: Week 2Population: 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.
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.
Outcome measures
| Measure |
Corticosteroid Injection/ Local Anesthetic (CSI/LA)
n=17 Participants
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
|
Local Anesthetic (LA)/Saline Injection
n=15 Participants
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
|
|---|---|---|
|
Visual Analog Scale Score - General Heel Tenderness
|
35.9 score on a scale
Standard Deviation 23.1
|
41.8 score on a scale
Standard Deviation 20.3
|
PRIMARY outcome
Timeframe: Week 4Population: 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.
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.
Outcome measures
| Measure |
Corticosteroid Injection/ Local Anesthetic (CSI/LA)
n=16 Participants
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
|
Local Anesthetic (LA)/Saline Injection
n=16 Participants
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
|
|---|---|---|
|
Visual Analog Scale Score - General Heel Tenderness
|
36.6 score on a scale
Standard Deviation 25.6
|
32.6 score on a scale
Standard Deviation 21.8
|
PRIMARY outcome
Timeframe: Week 8Population: 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
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.
Outcome measures
| Measure |
Corticosteroid Injection/ Local Anesthetic (CSI/LA)
n=13 Participants
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
|
Local Anesthetic (LA)/Saline Injection
n=16 Participants
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
|
|---|---|---|
|
Visual Analog Scale Score - General Heel Tenderness
|
29.3 score on a scale
Standard Deviation 30.8
|
22.6 score on a scale
Standard Deviation 19.6
|
PRIMARY outcome
Timeframe: Week 12Population: 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
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.
Outcome measures
| Measure |
Corticosteroid Injection/ Local Anesthetic (CSI/LA)
n=16 Participants
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
|
Local Anesthetic (LA)/Saline Injection
n=15 Participants
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
|
|---|---|---|
|
Visual Analog Scale Score - General Heel Tenderness
|
31.4 score on a scale
Standard Deviation 25.3
|
24.4 score on a scale
Standard Deviation 23.7
|
PRIMARY outcome
Timeframe: BaselineA 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.
Outcome measures
| Measure |
Corticosteroid Injection/ Local Anesthetic (CSI/LA)
n=21 Participants
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
|
Local Anesthetic (LA)/Saline Injection
n=20 Participants
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
|
|---|---|---|
|
Visual Analog Scale Score - First Step Pain
|
62.6 score on a scale
Standard Deviation 20.2
|
70.6 score on a scale
Standard Deviation 15.3
|
PRIMARY outcome
Timeframe: Week 2Population: 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.
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.
Outcome measures
| Measure |
Corticosteroid Injection/ Local Anesthetic (CSI/LA)
n=17 Participants
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
|
Local Anesthetic (LA)/Saline Injection
n=17 Participants
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
|
|---|---|---|
|
Visual Analog Scale Score - First Step Pain
|
40.4 score on a scale
Standard Deviation 26.3
|
50.6 score on a scale
Standard Deviation 23.1
|
PRIMARY outcome
Timeframe: Week 4Population: 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.
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.
Outcome measures
| Measure |
Corticosteroid Injection/ Local Anesthetic (CSI/LA)
n=17 Participants
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
|
Local Anesthetic (LA)/Saline Injection
n=17 Participants
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
|
|---|---|---|
|
Visual Analog Scale Score - First Step Pain
|
40.3 score on a scale
Standard Deviation 27.9
|
37.8 score on a scale
Standard Deviation 23.6
|
PRIMARY outcome
Timeframe: Week 8Population: 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.
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.
Outcome measures
| Measure |
Corticosteroid Injection/ Local Anesthetic (CSI/LA)
n=14 Participants
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
|
Local Anesthetic (LA)/Saline Injection
n=15 Participants
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
|
|---|---|---|
|
Visual Analog Scale Score - First Step Pain
|
38.7 score on a scale
Standard Deviation 32.7
|
24.9 score on a scale
Standard Deviation 23.0
|
PRIMARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Corticosteroid Injection/ Local Anesthetic (CSI/LA)
n=16 Participants
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
|
Local Anesthetic (LA)/Saline Injection
n=15 Participants
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
|
|---|---|---|
|
Visual Analog Scale Score - First Step Pain
|
37.1 score on a scale
Standard Deviation 29.8
|
22.9 score on a scale
Standard Deviation 22.6
|
PRIMARY outcome
Timeframe: BaselineQuestionnaire 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.
Outcome measures
| Measure |
Corticosteroid Injection/ Local Anesthetic (CSI/LA)
n=21 Participants
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
|
Local Anesthetic (LA)/Saline Injection
n=20 Participants
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
|
|---|---|---|
|
Foot Function Index (FFI) Score
|
42.4 score on a scale
Standard Deviation 13.5
|
43.5 score on a scale
Standard Deviation 15.2
|
PRIMARY outcome
Timeframe: Week 2Population: 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.
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.
Outcome measures
| Measure |
Corticosteroid Injection/ Local Anesthetic (CSI/LA)
n=18 Participants
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
|
Local Anesthetic (LA)/Saline Injection
n=18 Participants
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
|
|---|---|---|
|
Foot Function Index (FFI) Score
|
28.3 score on a scale
Standard Deviation 16.6
|
33.1 score on a scale
Standard Deviation 15.5
|
PRIMARY outcome
Timeframe: Week 4Population: 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.
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.
Outcome measures
| Measure |
Corticosteroid Injection/ Local Anesthetic (CSI/LA)
n=18 Participants
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
|
Local Anesthetic (LA)/Saline Injection
n=17 Participants
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
|
|---|---|---|
|
Foot Function Index (FFI) Score
|
22.2 score on a scale
Standard Deviation 16.9
|
25.3 score on a scale
Standard Deviation 18.8
|
PRIMARY outcome
Timeframe: Week 8Population: 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.
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.
Outcome measures
| Measure |
Corticosteroid Injection/ Local Anesthetic (CSI/LA)
n=14 Participants
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
|
Local Anesthetic (LA)/Saline Injection
n=16 Participants
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
|
|---|---|---|
|
Foot Function Index (FFI) Score
|
22.6 score on a scale
Standard Deviation 20.2
|
17.1 score on a scale
Standard Deviation 17.2
|
PRIMARY outcome
Timeframe: Week 12Population: For the CSI/LA arm, 5 participants did not complete study. For the LA/saline arm, 5 participants did not complete study.
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.
Outcome measures
| Measure |
Corticosteroid Injection/ Local Anesthetic (CSI/LA)
n=16 Participants
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
|
Local Anesthetic (LA)/Saline Injection
n=15 Participants
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
|
|---|---|---|
|
Foot Function Index (FFI) Score
|
26.5 score on a scale
Standard Deviation 23.3
|
18.6 score on a scale
Standard Deviation 20.2
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Corticosteroid Injection/ Local Anesthetic (CSI/LA)
n=15 Participants
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
|
Local Anesthetic (LA)/Saline Injection
n=15 Participants
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
|
|---|---|---|
|
Exit Survey Score
|
8.8 score on a scale
Standard Deviation 1.8
|
9.6 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Week 2, Week 4, Week 8, and Week 12Population: 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.
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.
Outcome measures
| Measure |
Corticosteroid Injection/ Local Anesthetic (CSI/LA)
n=21 Participants
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
|
Local Anesthetic (LA)/Saline Injection
n=20 Participants
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
|
|---|---|---|
|
Number of Completed Exercises
week 2
|
14.1 exercises completed
Standard Deviation 3.0
|
13.8 exercises completed
Standard Deviation 1.3
|
|
Number of Completed Exercises
week 4
|
13.8 exercises completed
Standard Deviation 2.7
|
15.9 exercises completed
Standard Deviation 3.3
|
|
Number of Completed Exercises
week 8
|
26.2 exercises completed
Standard Deviation 4.9
|
25.1 exercises completed
Standard Deviation 5.6
|
|
Number of Completed Exercises
week 12
|
26.9 exercises completed
Standard Deviation 4.2
|
27.2 exercises completed
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, and Week 12Population: 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.
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.
Outcome measures
| Measure |
Corticosteroid Injection/ Local Anesthetic (CSI/LA)
n=21 Participants
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
|
Local Anesthetic (LA)/Saline Injection
n=20 Participants
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
|
|---|---|---|
|
Heel Pressure Threshold Score - Symptomatic Foot
baseline
|
12.3 score on a scale
Standard Deviation 7.2
|
12.3 score on a scale
Standard Deviation 6.8
|
|
Heel Pressure Threshold Score - Symptomatic Foot
week 2
|
12.6 score on a scale
Standard Deviation 6.8
|
12.8 score on a scale
Standard Deviation 6.0
|
|
Heel Pressure Threshold Score - Symptomatic Foot
week 4
|
12.5 score on a scale
Standard Deviation 5.7
|
14.1 score on a scale
Standard Deviation 5.9
|
|
Heel Pressure Threshold Score - Symptomatic Foot
week 8
|
13.4 score on a scale
Standard Deviation 6.8
|
13.1 score on a scale
Standard Deviation 5.9
|
|
Heel Pressure Threshold Score - Symptomatic Foot
week 12
|
12.8 score on a scale
Standard Deviation 7.0
|
15.4 score on a scale
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12Population: 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.
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.
Outcome measures
| Measure |
Corticosteroid Injection/ Local Anesthetic (CSI/LA)
n=21 Participants
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
|
Local Anesthetic (LA)/Saline Injection
n=20 Participants
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
|
|---|---|---|
|
Heel Pressure Threshold Score - Asymptomatic Foot
baseline
|
16.0 score on a scale
Standard Deviation 6.5
|
18.0 score on a scale
Standard Deviation 11.5
|
|
Heel Pressure Threshold Score - Asymptomatic Foot
week 2
|
15.7 score on a scale
Standard Deviation 7.7
|
19.2 score on a scale
Standard Deviation 12.1
|
|
Heel Pressure Threshold Score - Asymptomatic Foot
week 4
|
14.5 score on a scale
Standard Deviation 5.3
|
17.1 score on a scale
Standard Deviation 8.7
|
|
Heel Pressure Threshold Score - Asymptomatic Foot
week 8
|
15.6 score on a scale
Standard Deviation 6.8
|
15.4 score on a scale
Standard Deviation 5.4
|
|
Heel Pressure Threshold Score - Asymptomatic Foot
week 12
|
14.4 score on a scale
Standard Deviation 6.1
|
15.2 score on a scale
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, and Week 12Population: 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.
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).
Outcome measures
| Measure |
Corticosteroid Injection/ Local Anesthetic (CSI/LA)
n=21 Participants
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
|
Local Anesthetic (LA)/Saline Injection
n=20 Participants
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
|
|---|---|---|
|
Heel Tenderness Score - Symptomatic Foot
baseline
|
1.95 score on a scale
Standard Deviation 0.65
|
1.75 score on a scale
Standard Deviation 0.62
|
|
Heel Tenderness Score - Symptomatic Foot
week 2
|
1.29 score on a scale
Standard Deviation 0.57
|
1.38 score on a scale
Standard Deviation 0.60
|
|
Heel Tenderness Score - Symptomatic Foot
week 4
|
1.18 score on a scale
Standard Deviation 0.78
|
1.35 score on a scale
Standard Deviation 0.76
|
|
Heel Tenderness Score - Symptomatic Foot
week 8
|
1.7 score on a scale
Standard Deviation 0.55
|
1.13 score on a scale
Standard Deviation 0.72
|
|
Heel Tenderness Score - Symptomatic Foot
week 12
|
1.0 score on a scale
Standard Deviation 0.82
|
1.0 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline, week 2, week 4, week 8, week 12Population: 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.
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).
Outcome measures
| Measure |
Corticosteroid Injection/ Local Anesthetic (CSI/LA)
n=21 Participants
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
|
Local Anesthetic (LA)/Saline Injection
n=20 Participants
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
|
|---|---|---|
|
Heel Tenderness Score - Asymptomatic Foot
baseline
|
0.32 score on a scale
Standard Deviation 0.57
|
0.33 score on a scale
Standard Deviation 0.58
|
|
Heel Tenderness Score - Asymptomatic Foot
week 2
|
0.18 score on a scale
Standard Deviation 0.38
|
0.21 score on a scale
Standard Deviation 0.56
|
|
Heel Tenderness Score - Asymptomatic Foot
week 4
|
0 score on a scale
Standard Deviation 0
|
0.12 score on a scale
Standard Deviation 0.47
|
|
Heel Tenderness Score - Asymptomatic Foot
week 8
|
0 score on a scale
Standard Deviation 0
|
0.07 score on a scale
Standard Deviation 0.25
|
|
Heel Tenderness Score - Asymptomatic Foot
week 12
|
0.27 score on a scale
Standard Deviation 0.57
|
0.21 score on a scale
Standard Deviation 0.77
|
Adverse Events
Corticosteroid Injection/ Local Anesthetic (CSI/LA)
Local Anesthetic (LA)/Saline Injection
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Corticosteroid Injection/ Local Anesthetic (CSI/LA)
n=21 participants at risk
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
|
Local Anesthetic (LA)/Saline Injection
n=20 participants at risk
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
|
|---|---|---|
|
General disorders
mass with sensation
|
0.00%
0/21 • Baseline through Week 12
|
5.0%
1/20 • Number of events 1 • Baseline through Week 12
|
|
General disorders
Fall
|
9.5%
2/21 • Number of events 2 • Baseline through Week 12
|
0.00%
0/20 • Baseline through Week 12
|
|
General disorders
oral surgery
|
0.00%
0/21 • Baseline through Week 12
|
5.0%
1/20 • Number of events 1 • Baseline through Week 12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place