Steroid Injections for Plantar Fasciitis (PF-RCT Trial)

N/A

Recruiting

Led By Donald S Malay, DPM

Research Sponsored by University of Pennsylvania

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 baseline to 3 months, 6 month, 9 month, and 12 month follow up

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare 2 types of injections for foot pain relief and measure effectiveness using pain, quality of life and fascia thickness.

Who is the study for?

This trial is for adults over 18 with plantar fasciitis, which causes heel pain. It's open to all ethnicities and smokers or non-smokers. People with diabetes without severe nerve damage can join too. But it's not for pregnant women, those with heel fractures or tumors, prior foot surgery within 5 years, chronic widespread pain conditions, allergies to the injections used in the study, bone infections in the heel, substance abuse issues, or certain neurological and vascular diseases.

What is being tested?

The trial tests two ways of giving a steroid shot for plantar fasciitis: one using ultrasound guidance (USGI) and another based on anatomy (ATGI). They're checking which method better reduces pain using a visual scale and improves life quality related to foot function. They'll also measure changes in the thickness of the painful tissue under your foot before and after treatment if you get USGI.

What are the potential side effects?

Possible side effects from the local steroid injection include pain at injection site, infection risk increase at injected area, potential weakening or rupture of nearby tendons temporarily increased blood sugar levels especially important for diabetics), facial flushing and skin discoloration around injected area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 3 months, 6 month, 9 month, and 12 month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 3 months, 6 month, 9 month, and 12 month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3 months, 6 month, 9 month, and 12 month follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in VAS pain score at post injection periods with use of ATGI

Change in VAS pain score at post injection periods with use of USGI

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Ultrasound Guided InjectionExperimental Treatment2 Interventions

Once patient has been randomized, if placed in the USGI group, the patient will be scheduled for an ultrasound therapy in the radiology department at Penn Presbyterian Medical Center. In this setting, the patient will be informed that in order to keep them blinded, that all patients must have either injection performed in the radiology department and that the ultrasound machine utilized will either be on or off during the injection keeping the patient blinded to the treatment modality. The area will then be prepped with alcohol to the medial heel and utilizing a medial approach, an injection of 0.5 cc 0.5% bupivacaine, 0.5 cc dexamethasone and 0.25 cc triamcinolone acetamide 40 mg/mL will be administered into the area surrounding the plantar fascia. The area will then be cleaned will alcohol and dressed with a small elastic bandage.

Group II: Anatomical injectionActive Control2 Interventions

Once patient has been randomized, if placed in the anatomically-guided injection group, the medial band of the plantar fascia origin on the calcaneus will be palpated and marked approximately. In the clinical setting, a sham ultrasound machine will be utilized to "locate" the plantar fascia keeping the patient blinded to the treatment modality. The area will then be prepped with alcohol to the medial heel and utilizing a medial approach, an injection of 0.5 cc 0.5% bupivacaine, 0.5 cc dexamethasone and 0.25 cc triamcinolone acetamide 40 mg/mL will be administered into the area surrounding the plantar fascia. The area will then be cleaned will alcohol and dressed with a small elastic bandage.

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