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Phase 1 N=41 Randomized Double-blind Treatment

Infracalcaneal Peppering Injection Technique for Chronic Plantar Fasciitis

Chronic Plantar Fasciitis

Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Visual Analog Scale Score - General Heel Tenderness — 46.7; 47.5 score on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Corticosteroid injection (CSI) with local anesthetic (LA) (Drug); Local anesthetic (LA) with Saline injection (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Wake Forest University Health Sciences
Primary completion
Sep 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Visual Analog Scale Score - General Heel Tenderness
31.4; 24.4
PRIMARY
Visual Analog Scale Score - General Heel Tenderness
31.4; 24.4
PRIMARY
Visual Analog Scale Score - General Heel Tenderness
31.4; 24.4
PRIMARY
Visual Analog Scale Score - General Heel Tenderness
31.4; 24.4
PRIMARY
Visual Analog Scale Score - General Heel Tenderness
31.4; 24.4
PRIMARY
Visual Analog Scale Score - First Step Pain
37.1; 22.9
PRIMARY
Visual Analog Scale Score - First Step Pain
37.1; 22.9
PRIMARY
Visual Analog Scale Score - First Step Pain
37.1; 22.9
PRIMARY
Visual Analog Scale Score - First Step Pain
37.1; 22.9
PRIMARY
Visual Analog Scale Score - First Step Pain
37.1; 22.9
PRIMARY
Foot Function Index (FFI) Score
26.5; 18.6
PRIMARY
Foot Function Index (FFI) Score
26.5; 18.6
PRIMARY
Foot Function Index (FFI) Score
26.5; 18.6
PRIMARY
Foot Function Index (FFI) Score
26.5; 18.6
PRIMARY
Foot Function Index (FFI) Score
26.5; 18.6
SECONDARY
Exit Survey Score
8.8; 9.6
SECONDARY
Number of Completed Exercises
14.1; 13.8; 13.8; 15.9; 26.2; 25.1
SECONDARY
Heel Pressure Threshold Score - Symptomatic Foot
12.3; 12.3; 12.6; 12.8; 12.5; 14.1
SECONDARY
Heel Pressure Threshold Score - Asymptomatic Foot
16.0; 18.0; 15.7; 19.2; 14.5; 17.1
SECONDARY
Heel Tenderness Score - Symptomatic Foot
1.95; 1.75; 1.29; 1.38; 1.18; 1.35
SECONDARY
Heel Tenderness Score - Asymptomatic Foot
0.32; 0.33; 0.18; 0.21; 0; 0.12

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05868577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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