Clinical trial NCT05868577: Infracalcaneal Peppering Injection Technique for Chronic Plantar Fasciitis
Official title: Infracalcaneal Peppering Injection Technique for Chronic Plantar Fasciitis: Protocol for a Parallel Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Plantar Fasciitis
Keywords: corticosteroid injection
infracalcaneal peppering injection
Plantar Fasciitis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2023-05-22
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients ages 18 years and up with a diagnosis of plantar heel pain will be screened for inclusion into the study.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - heel tenderness
timeFrame: Baseline
measure: Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - heel tenderness
timeFrame: Week 2
measure: Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - heel tenderness
timeFrame: Week 4
measure: Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - heel tenderness
timeFrame: Week 8
measure: Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - heel tenderness
timeFrame: Week 12
measure: Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - first step pain
timeFrame: Baseline
measure: Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - first step pain
timeFrame: Week 2
measure: Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - first step pain
timeFrame: Week 4
measure: Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - first step pain
timeFrame: Week 8
measure: Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - first step pain
timeFrame: Week 12
measure: Change in Foot Function Index (FFI) scores
timeFrame: Baseline
measure: Change in Foot Function Index (FFI) scores
timeFrame: Week 2
measure: Change in Foot Function Index (FFI) scores
timeFrame: Week 4
measure: Change in Foot Function Index (FFI) scores
timeFrame: Week 8
measure: Change in Foot Function Index (FFI) scores
timeFrame: Week 12
Secondary outcomes:
measure: Exit Survey Scores
timeFrame: Week12
measure: Patient Exercise Diary Results
timeFrame: Week 2, Week 4, Week 8, and Week12
measure: heel pressure threshold scores
timeFrame: Baseline, Week 2, Week 4, Week 8, and Week 12
measure: heel tenderness scores
timeFrame: Baseline, Week 2, Week 4, Week 8, and Week 12
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Michael A Jones, DPM
role: PRINCIPAL_INVESTIGATOR
References: