Infracalcaneal Peppering Injection Technique for Chronic Plantar Fasciitis

NCT05868577 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: IRB00095622UL1TR001420
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Plantar Fasciitis

Keywords

corticosteroid injection; infracalcaneal peppering injection; Plantar Fasciitis

Outcome Measures

Primary Outcomes (15)

• Visual Analog Scale Score - General Heel Tenderness

  A sheet of paper with a printed VAS scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their general heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range 0-100.

  Baseline

• Visual Analog Scale Score - General Heel Tenderness

  A sheet of paper with a printed visual analog score scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their general heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100.

  Week 2

• Visual Analog Scale Score - General Heel Tenderness

  A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their general heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range 0-100.

  Week 4

• Visual Analog Scale Score - General Heel Tenderness

  A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their general heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100.

  Week 8

• Visual Analog Scale Score - General Heel Tenderness

  A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their general heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100.

  Week 12

• Visual Analog Scale Score - First Step Pain

  A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their first step heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100.

  Baseline

• Visual Analog Scale Score - First Step Pain

  A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their first step heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100.

  Week 2

• Visual Analog Scale Score - First Step Pain

  A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their first step heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100.

  Week 4

• Visual Analog Scale Score - First Step Pain

  A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their first step heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100.

  Week 8

• Visual Analog Scale Score - First Step Pain

  A sheet of paper with a printed visual analog scale will be given to the patient. The patient will be instructed to make a bold dot on the line based on how they rate their first step heel pain, using the parameters listed on the scale (0 meaning no pain, 20 meaning mild pain, 50 meaning moderate pain, 80 meaning extreme pain, and 100 meaning the worst pain imaginable). Range = 0-100.

  Week 12

• Foot Function Index (FFI) Score

  Questionnaire that measures pain, activity limitation, and disability in the foot. The FFI consists of 23 items grouped into three subscales: (1) Pain (9 items); (2) Disability (9 items); and (3) Activity Limitation (5 items). Each item is rated on a scale from 0-9 for the Pain and Disability subscales and 0-5 for the Activity Limitation subscale. For each subscale, scores are summed, divided by the maximum possible total for applicable items (excluding any marked "not applicable"), and multiplied by 100 to yield a percentage score from 0 to 100. Lower FFI scores indicate better foot function, while higher FFI scores reflect greater impairment.

  Baseline

• Foot Function Index (FFI) Score

  Questionnaire that measures pain, activity limitation, and disability in the foot. The FFI consists of 23 items grouped into three subscales: (1) Pain (9 items); (2) Disability (9 items); and (3) Activity Limitation (5 items). Each item is rated on a scale from 0-9 for the Pain and Disability subscales and 0-5 for the Activity Limitation subscale. For each subscale, scores are summed, divided by the maximum possible total for applicable items (excluding any marked "not applicable"), and multiplied by 100 to yield a percentage score from 0 to 100. Lower FFI scores indicate better foot function, while higher FFI scores reflect greater impairment.

  Week 2

• Foot Function Index (FFI) Score

  Questionnaire that measures pain, activity limitation, and disability in the foot. The FFI consists of 23 items grouped into three subscales: (1) Pain (9 items); (2) Disability (9 items); and (3) Activity Limitation (5 items). Each item is rated on a scale from 0-9 for the Pain and Disability subscales and 0-5 for the Activity Limitation subscale. For each subscale, scores are summed, divided by the maximum possible total for applicable items (excluding any marked "not applicable"), and multiplied by 100 to yield a percentage score from 0 to 100. Lower FFI scores indicate better foot function, while higher FFI scores reflect greater impairment.

  Week 4

• Foot Function Index (FFI) Score

  Questionnaire that measures pain, activity limitation, and disability in the foot. The FFI consists of 23 items grouped into three subscales: (1) Pain (9 items); (2) Disability (9 items); and (3) Activity Limitation (5 items). Each item is rated on a scale from 0-9 for the Pain and Disability subscales and 0-5 for the Activity Limitation subscale. For each subscale, scores are summed, divided by the maximum possible total for applicable items (excluding any marked "not applicable"), and multiplied by 100 to yield a percentage score from 0 to 100. Lower FFI scores indicate better foot function, while higher FFI scores reflect greater impairment.

  Week 8

• Foot Function Index (FFI) Score

  Questionnaire that measures pain, activity limitation, and disability in the foot. The FFI consists of 23 items grouped into three subscales: (1) Pain (9 items); (2) Disability (9 items); and (3) Activity Limitation (5 items). Each item is rated on a scale from 0-9 for the Pain and Disability subscales and 0-5 for the Activity Limitation subscale. For each subscale, scores are summed, divided by the maximum possible total for applicable items (excluding any marked "not applicable"), and multiplied by 100 to yield a percentage score from 0 to 100. Lower FFI scores indicate better foot function, while higher FFI scores reflect greater impairment.

  Week 12

Secondary Outcomes (6)

• Exit Survey Score

  Week 12

• Number of Completed Exercises

  Week 2, Week 4, Week 8, and Week 12

• Heel Pressure Threshold Score - Symptomatic Foot

  Baseline, Week 2, Week 4, Week 8, and Week 12

• Heel Pressure Threshold Score - Asymptomatic Foot

  Baseline, Week 2, Week 4, Week 8, Week 12

• Heel Tenderness Score - Symptomatic Foot

  Baseline, Week 2, Week 4, Week 8, and Week 12

Study Arms (2)

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.

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.

Drug: Local anesthetic (LA) with Saline injection

Interventions

Corticosteroid injection (CSI) with local anesthetic (LA) DRUG

The PI will then administer the injection using an infracalcaneal needle peppering

Also known as: Corticosteroid injection

corticosteroid injection/ local anesthetic (CSI/LA)

Local anesthetic (LA) with Saline injection DRUG

The PI will then administer the injection using an infracalcaneal needle peppering

Also known as: Local anesthetic injection

local anesthetic (LA)/Saline injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Adrenal Cortex Hormones; Craniospinal Irradiation; Anesthetics, Local

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Radiotherapy; Therapeutics; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Results Point of Contact

• Title: Michael Jones, DPM
• Organization: Atrium Health Wake Forest Baptist

michael.jones4@advocatehealth.org

704-355-2000

Study Officials

• Michael A Jones, DPM

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients ages 18 years and up with a diagnosis of plantar heel pain will be screened for inclusion into the study.

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 22, 2023
• Study Start: October 18, 2023
• Primary Completion: September 18, 2024
• Study Completion: September 18, 2024
• Last Updated: October 30, 2025
• Results First Posted: October 30, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)