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Corticosteroid
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
PF-RCT Trial 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.Check my eligibility
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.See study design
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.
PF-RCT Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Secondary outcome measures
Foot-related quality of life outcomes as measured with use of the BFS
Foot-related quality of life outcomes as measured with use of the FFI
Observation of normal plantar fascia after treatment as measured by ultrasound (US)
PF-RCT 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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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,026 Total Patients Enrolled
Donald S Malay, DPMPrincipal InvestigatorPenn Presbyterian Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a tear or surgery in the tissue on the bottom of your foot called the plantar fascia within the last 5 years.You have diabetes, but you don't have nerve damage related to it.You have long-term pain or a condition called lumbosacral radiculitis.You are allergic to any of the ingredients in the injection therapy.You currently have or have had a bone infection in your calcaneus (heel bone).You have pain in the heel area and may have a bone spur that can be seen on an X-ray.You have a known addiction to drugs or alcohol.You are currently smoking, have smoked in the past, or have never smoked.You have peripheral vascular disease, but you don't experience leg pain when walking or at rest.You have a condition called collagen vascular disease, but you don't have any wounds on your legs.You have a neurological condition that requires taking pain-relieving, anti-seizure, or neuroleptic (medications that treat mental disorders) medications.You have a condition that affects the blood vessels in your arms or legs, causing pain while resting or walking, or the development of open sores.
Research Study Groups:
This trial has the following groups:- Group 1: Ultrasound Guided Injection
- Group 2: Anatomical injection
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings available for participants in this clinical trial?
"Affirmative, clinicaltrials.gov provides evidence that this study is currently enrolling patients; it was originally posted on March 28th 2017 and last modified on February 24th 2023. 62 individuals are needed to take part in the trial at a single location."
Answered by AI
How many patients are enrolled in this experiment at its fullest capacity?
"Affirmative. According to clinicaltrials.gov, this medical study which was initially posted on March 28th 2017 is currently seeking subjects for participation. The trial requires enrollment of 62 patients at a single site and the data has been recently updated as of February 24th 2023."
Answered by AI
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