Infracalcaneal Peppering Injection Technique for Chronic Plantar Fasciitis

Wake Forest University (WFU)

Status and phase: Completed; Phase 1

Conditions: Chronic Plantar Fasciitis

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05868577

IRB00095622

UL1TR001420 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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41 participants in 2 patient groups, including a placebo group

corticosteroid injection/ local anesthetic (CSI/LA)

Experimental group

Description:

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.

Treatment:

Drug: Corticosteroid injection (CSI) with local anesthetic (LA)

local anesthetic (LA)/Saline injection

Placebo Comparator group

Description:

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.

Treatment:

Drug: Local anesthetic (LA) with Saline injection