Infracalcaneal Peppering Injection Technique for Chronic Plantar Fasciitis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-18

Study Completion Date

2024-09-18

Brief Summary

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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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Detailed Description

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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.

Conditions

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Chronic Plantar Fasciitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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corticosteroid injection/ local anesthetic (CSI/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.

Group Type EXPERIMENTAL

Corticosteroid injection (CSI) with local anesthetic (LA)

Intervention Type DRUG

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

local anesthetic (LA)/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.

Group Type PLACEBO_COMPARATOR

Local anesthetic (LA) with Saline injection

Intervention Type DRUG

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

Interventions

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Corticosteroid injection (CSI) with local anesthetic (LA)

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

Intervention Type DRUG

Local anesthetic (LA) with Saline injection

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

Intervention Type DRUG

Other Intervention Names

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Corticosteroid injection Local anesthetic injection

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No