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Corticosteroid

Corticosteroid Injections for Plantar Fasciitis

Phase 1
Recruiting
Led By Michael A Jones, DPM
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 2, week 4, week 8, and week12
Awards & highlights

Study Summary

This trial suggests CSI+LA may offer short-term pain relief from plantar fasciitis, but has potential side effects and risks.

Who is the study for?
This trial is for men and women over 18 with chronic heel pain diagnosed as plantar fasciitis, lasting at least 6 weeks. It's not for pregnant individuals, those under 18, people with inflammatory arthritis or prior heel trauma/surgery, allergies to corticosteroids/anesthetics, previous heel injections, or diabetes.Check my eligibility
What is being tested?
The study tests two treatments for plantar fasciitis: one group receives a corticosteroid injection (CSI) combined with local anesthetic (LA), while the other gets LA with saline. The goal is to compare their effectiveness in short-term pain relief.See study design
What are the potential side effects?
Potential side effects of CSI include tissue damage around the heel, fat pad thinning beneath the skin, color changes on the skin surface and even risk of tearing the plantar fascia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 2, week 4, week 8, and week12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2, week 4, week 8, and week12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Foot Function Index (FFI) scores
Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - first step pain
Change in Visual Analog Scale as a Comprehensible Patient-Reported Outcome Measure (VAS PROM) scores - heel tenderness
Secondary outcome measures
Exit Survey Scores
Patient Exercise Diary Results
heel pressure threshold scores
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: corticosteroid injection/ local anesthetic (CSI/LA)Experimental Treatment1 Intervention
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.
Group II: local anesthetic (LA)/Saline injectionPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,243 Previous Clinical Trials
1,004,676 Total Patients Enrolled
Michael A Jones, DPMPrincipal InvestigatorWake Forest University Health Sciences

Media Library

Corticosteroid injection (CSI) with local anesthetic (LA) (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05868577 — Phase 1
Plantar Fasciitis Research Study Groups: corticosteroid injection/ local anesthetic (CSI/LA), local anesthetic (LA)/Saline injection
Plantar Fasciitis Clinical Trial 2023: Corticosteroid injection (CSI) with local anesthetic (LA) Highlights & Side Effects. Trial Name: NCT05868577 — Phase 1
Corticosteroid injection (CSI) with local anesthetic (LA) (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05868577 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA approved corticosteroid injection/ local anesthetic (CSI/LA) for use?

"The relative safety of corticosteroid injection/ local anesthetic (CSI/LA) was given a score of 1, as this is still in the early stages and there are few data points to support its efficacy."

Answered by AI

Are there any unoccupied positions in this experiment available to participants?

"From the information on clinicaltrials.gov, this trial appears to have concluded its patient recruitment process as it was last updated on May 11th 2023. However, there are currently 32 other trials that accept participants at this time."

Answered by AI

What aims are this experiment aiming to accomplish?

"The principal aim of this trial, which is scheduled to conclude in Week 12, is the evaluation of patient-reported outcome measures (VAS PROM) scores concerning initial step pain. Secondary objectives consist of Patient Stretching and Strengthening Exercise Compliance Questionnaire Scores, heel pressure threshold ratings on a 10 point scale from 0 - no pain to 10 - extreme agony as well as heel tenderness index with values ranging between 0 and 3 points."

Answered by AI
~23 spots leftby Oct 2024