Chronic Plantar FasciitisPhase 1NCT05868577
Infracalcaneal Peppering Injection Technique for Chronic Plantar Fasciitis
A Phase 1 study testing Corticosteroid injection (CSI) with local anesthetic (LA) and Local anesthetic (LA) with Saline injection in people with Chronic Plantar Fasciitis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Plantar Fasciitis
- What is being tested?
- Corticosteroid injection (CSI) with local anesthetic (LA) and Local anesthetic (LA) with Saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2023to 18 Sep 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Infracalcaneal Peppering Injection Technique for Chronic Plantar Fasciitis: Protocol for a Parallel Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Chronic Plantar Fasciitis
- Being tested
- Corticosteroid injection (CSI) with local anesthetic (LA), Local anesthetic (LA) with Saline injection
- Keywords
- corticosteroid injection, infracalcaneal peppering injection, Plantar Fasciitis
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid injection (CSI) with local anesthetic (LA)Drug
Also called Corticosteroid injection
The PI will then administer the injection using an infracalcaneal needle peppering
Local anesthetic (LA) with Saline injectionDrug
Also called Local anesthetic injection
The PI will then administer the injection using an infracalcaneal needle peppering
| Study group | Role | What they receive |
|---|---|---|
| corticosteroid injection/ local anesthetic (CSI/LA) | Experimental | 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. Receives: Drug: Corticosteroid injection (CSI) with local anesthetic (LA) |
| local anesthetic (LA)/Saline injection | Placebo comparator | 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. Receives: Drug: Local anesthetic (LA) with Saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Visual Analog Scale Score - General Heel Tenderness
A sheet of paper with a printed visual analog score scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their general heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100.
Measured: Week 2
Visual Analog Scale Score - General Heel Tenderness
A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their general heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range 0-100.
Measured: Week 4
Visual Analog Scale Score - General Heel Tenderness
A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their general heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100.
Measured: Week 8
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.
Measured: Week 12
Visual Analog Scale Score - First Step Pain
A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their first step heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100.
Measured: Baseline
Visual Analog Scale Score - First Step Pain
A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their first step heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100.
Measured: Week 2
Visual Analog Scale Score - First Step Pain
A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their first step heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100.
Measured: Week 4
Visual Analog Scale Score - First Step Pain
A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their first step heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100.
Measured: Week 8
Visual Analog Scale Score - First Step Pain
A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their first step heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100.
Measured: Week 12
Foot Function Index (FFI) Score
Questionnaire that measures pain, activity limitation, and disability in the foot. The FFI consists of 23 items grouped into three subscales: (1) Pain (9 items); (2) Disability (9 items); and (3) Activity Limitation (5 items). Each item is rated on a scale from 0-9 for the Pain and Disability subscales and 0-5 for the Activity Limitation subscale. For each subscale, scores are summed, divided by the maximum possible total for applicable items (excluding any marked "not applicable"), and multiplied by 100 to yield a percentage score from 0 to 100. Lower FFI scores indicate better foot function, while higher FFI scores reflect greater impairment.
Measured: Baseline
Foot Function Index (FFI) Score
Questionnaire that measures pain, activity limitation, and disability in the foot. The FFI consists of 23 items grouped into three subscales: (1) Pain (9 items); (2) Disability (9 items); and (3) Activity Limitation (5 items). Each item is rated on a scale from 0-9 for the Pain and Disability subscales and 0-5 for the Activity Limitation subscale. For each subscale, scores are summed, divided by the maximum possible total for applicable items (excluding any marked "not applicable"), and multiplied by 100 to yield a percentage score from 0 to 100. Lower FFI scores indicate better foot function, while higher FFI scores reflect greater impairment.
Measured: Week 2
Foot Function Index (FFI) Score
Questionnaire that measures pain, activity limitation, and disability in the foot. The FFI consists of 23 items grouped into three subscales: (1) Pain (9 items); (2) Disability (9 items); and (3) Activity Limitation (5 items). Each item is rated on a scale from 0-9 for the Pain and Disability subscales and 0-5 for the Activity Limitation subscale. For each subscale, scores are summed, divided by the maximum possible total for applicable items (excluding any marked "not applicable"), and multiplied by 100 to yield a percentage score from 0 to 100. Lower FFI scores indicate better foot function, while higher FFI scores reflect greater impairment.
Measured: Week 4
Foot Function Index (FFI) Score
Questionnaire that measures pain, activity limitation, and disability in the foot. The FFI consists of 23 items grouped into three subscales: (1) Pain (9 items); (2) Disability (9 items); and (3) Activity Limitation (5 items). Each item is rated on a scale from 0-9 for the Pain and Disability subscales and 0-5 for the Activity Limitation subscale. For each subscale, scores are summed, divided by the maximum possible total for applicable items (excluding any marked "not applicable"), and multiplied by 100 to yield a percentage score from 0 to 100. Lower FFI scores indicate better foot function, while higher FFI scores reflect greater impairment.
Measured: Week 8
Foot Function Index (FFI) Score
Questionnaire that measures pain, activity limitation, and disability in the foot. The FFI consists of 23 items grouped into three subscales: (1) Pain (9 items); (2) Disability (9 items); and (3) Activity Limitation (5 items). Each item is rated on a scale from 0-9 for the Pain and Disability subscales and 0-5 for the Activity Limitation subscale. For each subscale, scores are summed, divided by the maximum possible total for applicable items (excluding any marked "not applicable"), and multiplied by 100 to yield a percentage score from 0 to 100. Lower FFI scores indicate better foot function, while higher FFI scores reflect greater impairment.
Measured: Week 12
Secondary outcomes (6)
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.
Measured: Week 12
Number of Completed Exercises
Participants will document in a daily exercise diary if any of the three recommended exercises (calf stretching, plantar fascia specific stretching, and loading exercise) were completed. Participants will also be asked to document why exercises were not completed if applicable.
Measured: Week 2, Week 4, Week 8, and Week 12
Heel Pressure Threshold Score - Symptomatic Foot
Using a dolorimeter each participant's heel pressure threshold will be assessed. Level of pain on a 35-point scale will be noted with 0 meaning no pain and 35 meaning extreme pain.
Measured: Baseline, Week 2, Week 4, Week 8, and Week 12
Heel Pressure Threshold Score - Asymptomatic Foot
Using a dolorimeter each participant's heel pressure threshold will be assessed. Level of pain on a 35-point scale will be noted with 0 meaning no pain and 35 meaning extreme pain.
Measured: Baseline, Week 2, Week 4, Week 8, Week 12
Heel Tenderness Score - Symptomatic Foot
The physician will assess heel pain on palpation. Heel tenderness index will be used which has a range of 0-3 points (0 points = no pain, 1 point = painful, 2 points = painful and winces, 3 points = painful, winces, and withdraws).
Measured: Baseline, Week 2, Week 4, Week 8, and Week 12
Heel Tenderness Score - Asymptomatic Foot
The physician will assess heel pain on palpation. Heel tenderness index will be used which has a range of 0-3 points (0 points = no pain, 1 point = painful, 2 points = painful and winces, 3 points = painful, winces, and withdraws).
Measured: Baseline, week 2, week 4, week 8, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start18 Oct 2023
- Primary completion18 Sep 2024
- Study completion18 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Plantar FasciitisStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients ages 18 years and up with a diagnosis of plantar heel pain will be screened for inclusion into the study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Michael A Jones, DPM, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868577
- Sponsor's protocol ID
- IRB00095622
- Other IDs
- UL1TR001420
- Status last verified
- Mar 2024
- First submitted
- 11 May 2023
- Last updated
- 30 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infracalcaneal Peppering Injection Technique for Chronic Plantar Fasciitis: Protocol for a Parallel Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05868577
- Acronym / sponsor ID
- IRB00095622
- Conditions
- Chronic Plantar Fasciitis
- Keywords
- corticosteroid injection, infracalcaneal peppering injection, Plantar Fasciitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 18 Sep 2024 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Posted 30 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- All patients ages 18 years and up with a diagnosis of plantar heel pain will be screened for inclusion into the study.
| Arm | Type | Receives |
|---|---|---|
| corticosteroid injection/ local anesthetic (CSI/LA) | Experimental | Drug: Corticosteroid injection (CSI) with local anesthetic (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. |
| local anesthetic (LA)/Saline injection | Placebo comparator | Drug: Local anesthetic (LA) with Saline injectionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corticosteroid injection (CSI) with local anesthetic (LA)Also: Corticosteroid injectionThe PI will then administer the injection using an infracalcaneal needle peppering | Drug | corticosteroid injection/ local anesthetic (CSI/LA) |
| Local anesthetic (LA) with Saline injectionAlso: Local anesthetic injectionThe PI will then administer the injection using an infracalcaneal needle peppering | Drug | local anesthetic (LA)/Saline injection |
Primary outcome
Visual Analog Scale Score - General Heel Tenderness
Time frame: 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 - General Heel Tenderness
Time frame: Week 2
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.
Visual Analog Scale Score - General Heel Tenderness
Time frame: Week 4
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.
Visual Analog Scale Score - General Heel Tenderness
Time frame: Week 8
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.
Visual Analog Scale Score - General Heel Tenderness
Time frame: Week 12
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.
Visual Analog Scale Score - First Step Pain
Time frame: 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.
Visual Analog Scale Score - First Step Pain
Time frame: Week 2
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.
Visual Analog Scale Score - First Step Pain
Time frame: Week 4
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.
Visual Analog Scale Score - First Step Pain
Time frame: Week 8
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.
Visual Analog Scale Score - First Step Pain
Time frame: Week 12
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
Time frame: 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.
Foot Function Index (FFI) Score
Time frame: Week 2
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.
Foot Function Index (FFI) Score
Time frame: Week 4
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.
Foot Function Index (FFI) Score
Time frame: Week 8
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.
Foot Function Index (FFI) Score
Time frame: Week 12
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.
6 secondary outcomes
Exit Survey Score
Time frame: Week 12
Number of Completed Exercises
Time frame: Week 2, Week 4, Week 8, and Week 12
Heel Pressure Threshold Score - Symptomatic Foot
Time frame: Baseline, Week 2, Week 4, Week 8, and Week 12
Heel Pressure Threshold Score - Asymptomatic Foot
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12
Heel Tenderness Score - Symptomatic Foot
Time frame: Baseline, Week 2, Week 4, Week 8, and Week 12
Heel Tenderness Score - Asymptomatic Foot
Time frame: Baseline, week 2, week 4, week 8, week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Jones, DPM principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Corticosteroid injection (CSI) with local anesthetic (LA) and Local anesthetic (LA) with Saline injection in people with Chronic Plantar Fasciitis, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale Score - General Heel Tenderness (time frame: Baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.