Infracalcaneal Peppering Injection Technique for Chronic Plantar Fasciitis

Phase 1

Completed

Conditions: Chronic Plantar Fasciitis

Interventions: Drug: Corticosteroid injection (CSI) with local anesthetic (LA)
Drug: Local anesthetic (LA) with Saline injection

Registration Number: NCT05868577

Lead Sponsor: Wake Forest University Health Sciences

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 41

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
corticosteroid injection/ local anesthetic (CSI/LA)	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	Local anesthetic (LA) with 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.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale Score - General Heel Tenderness	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	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	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 Outcome Measures

Name	Time	Method
Exit Survey Score	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.
Number of Completed Exercises	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.
Heel Pressure Threshold Score - Symptomatic Foot	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.
Heel Pressure Threshold Score - Asymptomatic Foot	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.
Heel Tenderness Score - Symptomatic Foot	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).
Heel Tenderness Score - Asymptomatic Foot	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).

Trial Locations

Locations (1): Wake Forest University Health Sciences
🇺🇸
Winston-Salem, North Carolina, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States