Infracalcaneal Peppering Injection Technique for Chronic Plantar Fasciitis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: corticosteroid injection/ local anesthetic (CSI/LA) 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 The hypodermic needle is withdrawn while at the same depositing injectate The hypodermic needle is redirected without emerging from the skin.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)
The PI will then administer the injection using an infracalcaneal needle peppering
Other Names:
|
| Placebo Comparator: local anesthetic (LA)/Saline injection 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
The PI will then administer the injection using an infracalcaneal needle peppering
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - heel tenderness [Baseline]
"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.
- Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - heel tenderness [Week 2]
"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.
- Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - heel tenderness [Week 4]
"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.
- Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - heel tenderness [Week 8]
"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.
- Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - heel tenderness [Week 12]
"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.
- Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - first step pain [Baseline]
"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.
- Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - first step pain [Week 2]
"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.
- Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - first step pain [Week 4]
"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.
- Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - first step pain [Week 8]
"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.
- Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - first step pain [Week 12]
"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.
- Change in Foot Health Status Questionnaire Patient-Reported Outcome Measure (FHSQ PROM) scores [Baseline]
Patient self-assessment of heel pain - Patient will be given a printed copy of the Foot Health Status Questionnaire (FHSQ), version 1.04 - FHSQ range = 0 (poorest state of foot health) - 100 (optimal foot health)
- Change in Foot Health Status Questionnaire Patient-Reported Outcome Measure (FHSQ PROM) scores [Week 2]
Patient self-assessment of heel pain - Patient will be given a printed copy of the Foot Health Status Questionnaire (FHSQ), version 1.04. - FHSQ range = 0 (poorest state of foot health) - 100 (optimal foot health)
- Change in Foot Health Status Questionnaire Patient-Reported Outcome Measure (FHSQ PROM) scores [Week 4]
Patient self-assessment of heel pain - Patient will be given a printed copy of the Foot Health Status Questionnaire (FHSQ), version 1.04.
- Change in Foot Health Status Questionnaire Patient-Reported Outcome Measure (FHSQ PROM) scores [Week 8]
Patient self-assessment of heel pain - Patient will be given a printed copy of the Foot Health Status Questionnaire (FHSQ), version 1.04 - FHSQ range = 0 (poorest state of foot health) - 100 (optimal foot health)
- Change in Foot Health Status Questionnaire Patient-Reported Outcome Measure (FHSQ PROM) scores [Week 12]
Patient self-assessment of heel pain - Patient will be given a printed copy of the Foot Health Status Questionnaire (FHSQ), version 1.04 - FHSQ range = 0 (poorest state of foot health) - 100 (optimal foot health)
Secondary Outcome Measures
- Exit Survey Scores [Week12]
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.
- Patient Stretching and Strengthening Exercise Compliance Questionnaire Scores [Week 2, Week 4, Week 8, and Week12]
Participants will be given a paper copy of this questionnaire to assess their beliefs regarding the injection and if they completed the recommended stretching and strengthening exercises. The questionnaire consists of 4 questions, with each question having both "yes" and "no" answer choices. The first two questions ask directly if the participant completed the recommended exercises. If a participant selects no, they are asked to explain why they did not complete the exercises by free response. Participants will complete the questionnaire independently.
- heel pressure threshold scores [Baseline, Week 2, Week 4, Week 8, and Week 12]
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.
- heel tenderness scores [Baseline, Week 2, Week 4, Week 8, and Week 12]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Men and women 18 years of age and older
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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:
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Individuals less than 18 years of age
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Pregnancy
-
History of local heel injection (i.e. corticosteroid injection (CSI) or other injectate)
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History of diabetes mellitus
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History of inflammatory arthritis
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Prior heel trauma or surgery
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Allergy to local corticosteroid or local anesthesia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wake Forest University Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Michael A Jones, DPM, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00095622