Infracalcaneal Peppering Injection Technique for Chronic Plantar Fasciitis

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Plantar Fasciitis

Intervention / Treatment
-----------------
* Drug: Corticosteroid injection (CSI) with local anesthetic (LA)
* Drug: Local anesthetic (LA) with Saline injection


Participation Criteria
=================
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 local heel injection (i.e. corticosteroid injection (CSI) or other injectate) History of diabetes mellitus History of inflammatory arthritis Prior heel trauma or surgery Allergy to local corticosteroid or local anesthesia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All patients ages 18 years and up with a diagnosis of plantar heel pain will be screened for inclusion into the study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: corticosteroid injection/ local anesthetic (CSI/LA)<br>The PI will then administer the (CSI/LA) injection using an infracalcaneal needle peppering technique as follows: The hypodermic needle is inserted using infracalcaneal injection approach. The hypodermic needle is withdrawn while at the same depositing injectate The hypodermic needle is redirected without emerging from the skin. The PI will perform steps 1-3 standardly 20-25 times. | Drug: Corticosteroid injection (CSI) with local anesthetic (LA)<br>* The PI will then administer the injection using an infracalcaneal needle peppering<br>* Other names: Corticosteroid injection;|
| Placebo Comparator: local anesthetic (LA)/Saline injection<br>The PI will then administer the (LA/Saline) injection using an infracalcaneal needle peppering technique as follows: The hypodermic needle is inserted using infracalcaneal injection approach. The hypodermic needle is withdrawn while at the same depositing injectate The hypodermic needle is redirected without emerging from the skin. The PI will perform steps 1-3 standardly 20-25 times. | Drug: Local anesthetic (LA) with Saline injection<br>* The PI will then administer the injection using an infracalcaneal needle peppering<br>* Other names: Local anesthetic injection;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
corticosteroid injection, infracalcaneal peppering injection, Plantar Fasciitis