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Completed

NCT Number: NCT05868577

Infracalcaneal Peppering Injection Technique for Chronic Plantar Fasciitis

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.

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Key information

Conditions

Chronic Plantar Fasciitis Fasciitis Fasciitis, Plantar Foot Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women 18 years of age and older
  • Patient reported history of plantar heel pain and confirmed clinical tenderness of pain with direct palpation of the medial calcaneal tubercle on baseline exam
  • Diagnosis of chronic plantar fasciitis, defined for study purposes as symptoms greater than or equal to 6 weeks in duration

Exclusion criteria

  • Individuals less than 18 years of age
  • Pregnancy
  • History of receiving a local heel injection (i.e. corticosteroid injection (CSI) or other injectate) within the last 3 months
  • Prior heel trauma or surgery
  • Allergy to local corticosteroid or local anesthesia

Treatment and study plan

Corticosteroid injection (CSI) with local anesthetic (LA)

Drug

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

Other names: Corticosteroid injection

Local anesthetic (LA) with Saline injection

Drug

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

Other names: Local anesthetic injection

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

Secondary outcomes

  1. Exit Survey Score

    Time frame: Week 12

    Upon completion of study related procedures and assessments, participants will be given a paper exit survey to complete. 5 questions asked relating to their experience in the study and if they would recommend the study to others. Total score range 1-10 with 1 being worst experience and 10 being best experience.

  2. Number of Completed Exercises

    Time frame: Week 2, Week 4, Week 8, and Week 12

    Participants will document in a daily exercise diary if any of the three recommended exercises (calf stretching, plantar fascia specific stretching, and loading exercise) were completed. Participants will also be asked to document why exercises were not completed if applicable.

  3. Heel Pressure Threshold Score - Symptomatic Foot

    Time frame: Baseline, Week 2, Week 4, Week 8, and Week 12

    Using a dolorimeter each participant's heel pressure threshold will be assessed. Level of pain on a 35-point scale will be noted with 0 meaning no pain and 35 meaning extreme pain.

  4. Heel Pressure Threshold Score - Asymptomatic Foot

    Time frame: Baseline, Week 2, Week 4, Week 8, Week 12

    Using a dolorimeter each participant's heel pressure threshold will be assessed. Level of pain on a 35-point scale will be noted with 0 meaning no pain and 35 meaning extreme pain.

  5. Heel Tenderness Score - Symptomatic Foot

    Time frame: Baseline, Week 2, Week 4, Week 8, and Week 12

    The physician will assess heel pain on palpation. Heel tenderness index will be used which has a range of 0-3 points (0 points = no pain, 1 point = painful, 2 points = painful and winces, 3 points = painful, winces, and withdraws).

  6. Heel Tenderness Score - Asymptomatic Foot

    Time frame: Baseline, week 2, week 4, week 8, week 12

    The physician will assess heel pain on palpation. Heel tenderness index will be used which has a range of 0-3 points (0 points = no pain, 1 point = painful, 2 points = painful and winces, 3 points = painful, winces, and withdraws).

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

Infracalcaneal Peppering Injection Technique for Chronic Plantar Fasciitis: Protocol for a Parallel Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 22, 2023
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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