Infracalcaneal Peppering Injection Technique for Chronic Plantar Fasciitis

Chronic Plantar Fasciitis Clinical Trial

Official title:

Infracalcaneal Peppering Injection Technique for Chronic Plantar Fasciitis: Protocol for a Parallel Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05868577
• Other study ID #: IRB00095622
• Status: Recruiting
• Phase: Phase 1
• Start date: October 18, 2023
• Est. completion date: October 2024

Study information

• Verified date: March 2024
• Source: Wake Forest University Health Sciences
• Contact: Martha Holden
• Phone: 336-716-5457
• Email: mholden[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Plantar Fasciitis
• Fasciitis
• Fasciitis, Plantar

Intervention

Drug:
• Corticosteroid injection (CSI) with local anesthetic (LA)
The PI will then administer the injection using an infracalcaneal needle peppering
• Local anesthetic (LA) with Saline injection
The PI will then administer the injection using an infracalcaneal needle peppering

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - heel tenderness	"general heel pain" - A sheet of paper with a printed VAS 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 mm.	Baseline
Primary	Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - heel tenderness	"general heel pain" - A sheet of paper with a printed VAS 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 mm.	Week 2
Primary	Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - heel tenderness	"general heel pain" - A sheet of paper with a printed VAS 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 mm.	Week 4
Primary	Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - heel tenderness	"general heel pain" - A sheet of paper with a printed VAS 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 mm.	Week 8
Primary	Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - heel tenderness	"general heel pain" - A sheet of paper with a printed VAS 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 mm.	Week 12
Primary	Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - first step pain	"first step pain" - A sheet of paper with a printed VAS 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 mm.	Baseline
Primary	Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - first step pain	"first step pain" - A sheet of paper with a printed VAS 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 mm.	Week 2
Primary	Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - first step pain	"first step pain" - A sheet of paper with a printed VAS 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 mm.	Week 4
Primary	Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - first step pain	"first step pain" - A sheet of paper with a printed VAS 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 mm.	Week 8
Primary	Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - first step pain	"first step pain" - A sheet of paper with a printed VAS 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 mm.	Week 12
Primary	Change in Foot Function Index (FFI) scores	Zero represents no pain/disability, and 10 represents the worst pain imaginable/severe disability for each item - scores between 0 to 170 points as an overall score - sub-category scores (pain - total of 50 points max, disability - total of 90 points max, and activity limitation - total of 30 points max).	Baseline
Primary	Change in Foot Function Index (FFI) scores	Zero represents no pain/disability, and 10 represents the worst pain imaginable/severe disability for each item - scores between 0 to 170 points as an overall score - sub-category scores (pain - total of 50 points max, disability - total of 90 points max, and activity limitation - total of 30 points max).	Week 2
Primary	Change in Foot Function Index (FFI) scores	Zero represents no pain/disability, and 10 represents the worst pain imaginable/severe disability for each item - scores between 0 to 170 points as an overall score - sub-category scores (pain - total of 50 points max, disability - total of 90 points max, and activity limitation - total of 30 points max).	Week 4
Primary	Change in Foot Function Index (FFI) scores	Zero represents no pain/disability, and 10 represents the worst pain imaginable/severe disability for each item - scores between 0 to 170 points as an overall score - sub-category scores (pain - total of 50 points max, disability - total of 90 points max, and activity limitation - total of 30 points max).	Week 8
Primary	Change in Foot Function Index (FFI) scores	Zero represents no pain/disability, and 10 represents the worst pain imaginable/severe disability for each item - scores between 0 to 170 points as an overall score - sub-category scores (pain - total of 50 points max, disability - total of 90 points max, and activity limitation - total of 30 points max).	Week 12
Secondary	Exit Survey Scores	Upon completion of study related procedures and assessments, participants will be given a paper exit survey to complete. 5 questions will be asked relating to their experience in the study and if they would recommend the study to others. The first question asks participants to rate their experience [range = 1(worst experience) -10 (best experience)]. The next two questions will be answered by circling "yes" and "no". Questions 4 and 5 are free-response questions where participants will be able to document their likes and dislikes of the study.	Week12
Secondary	Patient Exercise Diary Results	Participants will document daily if they have completed any of the 3 recommended exercises (calf stretching, plantar fascia specific stretching, and loading exercise) . They will also be asked to document why they did not complete any exercises if applicable to them daily.	Week 2, Week 4, Week 8, and Week12
Secondary	heel pressure threshold scores	Using a dolorimeter, the PI will assess each participant's heel pressure threshold - describe the level of pain on a 10-point scale, with 0 meaning no pain and 10 meaning extreme pain.	Baseline, Week 2, Week 4, Week 8, and Week 12
Secondary	heel tenderness scores	this study will utilize the heel tenderness index 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). The physician will assess heel pain on palpation.	Baseline, Week 2, Week 4, Week 8, and Week 12