Trial Summary
What is the purpose of this trial?The primary aim of this clinical experiment is to compare, in terms of pain relief measured using the 10-cm visual analog scale (VAS) pain score (5-7), the clinical results of ultrasound-guided injection (USGI) versus anatomic topography-guided injection (ATGI) of corticosteroid for the treatment of proximal PF. Secondary aims will be to compare foot-related quality of life, as measured using the Foot Function Index (FFI)and the Bristol Foot Score (BFS), between the injection groups, and also to compare the pre-injection to late-term post-injection thickness of the plantar fascia as measured in the nested USGI group.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a neurological condition that requires analgesic, anti-seizure, or neuroleptic medications, you may be excluded from participating.
What data supports the idea that Steroid Injections for Plantar Fasciitis is an effective treatment?
The available research shows that steroid injections can be effective for treating plantar fasciitis, but the evidence is not very strong. One study compared steroid injections to platelet-rich plasma (PRP) and found that both treatments helped with plantar fasciitis, but it didn't clearly show that steroids were better. Another study compared steroid injections to botulinum toxin A and a local anesthetic, and it looked at how these treatments affected heel pain and foot movement. While steroid injections are commonly used and can help reduce pain, the research suggests that they are not always more effective than other treatments like PRP or botulinum toxin A.
12345What safety data is available for steroid injections in treating plantar fasciitis?
The safety data for steroid injections in treating plantar fasciitis includes a systematic review and meta-analysis that highlights limited high-quality evidence supporting the treatment. There is a rare case of iatrogenic calcaneal osteomyelitis following a plantar heel injection, suggesting that such injections should be performed in controlled environments to minimize infection risks. Additionally, a randomized controlled trial compared steroid injections with placebo and evaluated the use of ultrasound guidance, indicating ongoing research into optimizing safety and effectiveness.
12456Is the treatment of local steroid injection into the plantar heel a promising treatment for plantar fasciitis?
Local steroid injections can provide temporary pain relief for plantar fasciitis, which is a common cause of heel pain. This treatment is often used when other methods don't work, and it can help reduce pain quickly.
12357Eligibility Criteria
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.Inclusion Criteria
≥18 years of age
You have diabetes, but you don't have nerve damage related to it.
Male or non-pregnant female of any ethnicity or race
+4 more
Exclusion Criteria
Calcaneal stress fracture or show evidence of a foreign body or tumor of the affected heel as viewed radiographically
Pregnant females
Unable to consent to participation in clinical research or currently be involved in another clinical investigation.
+7 more
Participant Groups
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.
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.
Local Steroid Injection into the plantar heel is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Corticosteroid injection for:
- Plantar fasciitis
- Heel pain
🇪🇺 Approved in European Union as Corticosteroid injection for:
- Plantar fasciitis
- Heel pain
🇨🇦 Approved in Canada as Corticosteroid injection for:
- Plantar fasciitis
- Heel pain
🇦🇺 Approved in Australia as Corticosteroid injection for:
- Plantar fasciitis
- Heel pain
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Penn Presbyterian Medical CenterPhiladelphia, PA
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Who Is Running the Clinical Trial?
University of PennsylvaniaLead Sponsor
References
Corticosteroid injection for plantar heel pain: a systematic review and meta-analysis. [2022]Corticosteroid injection is frequently used for plantar heel pain (plantar fasciitis), although there is limited high-quality evidence to support this treatment. Therefore, this study reviewed randomised trials to estimate the effectiveness of corticosteroid injection for plantar heel pain.
Effect of corticosteroids over plantar fascia thickness in plantar fasciitis: a systematic review and meta-analysis. [2023]Corticosteroid injections have been typically used for the management of plantar fasciitis with apparently good clinical outcomes; however, there is no information of the effect of corticosteroids on the thickness of the plantar fascia which is typically altered in this pathology. We aimed determine whether treatment with corticosteroid injections induces plantar fascia thickness changes in plantar fasciitis.
The comparison of the effect of corticosteroids and platelet-rich plasma (PRP) for the treatment of plantar fasciitis. [2022]In this study, the results of local injection of platelet-rich plasma (PRP) and corticosteroids in the treatment of plantar fasciitis were compared.
Comparison of Botulinum Toxin A, Corticosteroid, and Anesthetic Injection for Plantar Fasciitis. [2022]Plantar fasciitis is the most common cause of heel pain, and injection therapies are part of the treatment modalities. This study aimed to compare 2 intralesional injection therapies for plantar fasciitis: corticosteroid and botulinum toxin A, compared with a third control group using a local anesthetic. The clinical evolution, as well as changes in the thickness of the plantar fascia and ankle dorsiflexion, was evaluated.
Steroid injection for inferior heel pain: a randomised controlled trial. [2022]Plantar fasciitis is a common cause of heel pain. The aim of this study was twofold: to compare steroid injection with placebo injection and to compare ultrasound guided with unguided steroid injection in the management of this condition.
Unexpected sequelae of plantar fasciitis: Iatrogenic calcaneal osteomyelitis following plantar heel injection. [2020]The injection of a local anesthetic in combination with a corticosteroid is an accepted choice in the treatment of plantar fasciitis with recalcitrant heel pain. When the injection is performed properly, post-injection infection is extremely rare. We are reporting a rare case of chronic calcaneal osteomyelitis that developed secondary to a local corticosteroid injection. A 56-year-old lady diagnosed with right plantar fasciitis presented with a 6-month history of pain and a persistent sinus with serous discharge of her right heel following a local infiltration of a corticosteroid. A Magnetic Resonance Imaging demonstrated right calcaneal osteomyelitis with intramuscular abscess. Surgical drainage and debridement were done, followed by antibiotic therapy. A recurrence of infection was not detected throughout the duration of follow-up. It is suggested that a plantar heel injection be done in a more controlled environment, such as in operating theatre, to reduce the risk of infection and to avoid injecting a steroid as compared to platelet-rich plasma (PRP) in view of their safety profiles. However, such an injection should only be offered after conservative treatment has failed, as 80% of patients recover well after initial conservative management.
Use of platelet rich plasma to treat plantar fasciitis: design of a multi centre randomized controlled trial. [2021]If conservative treatment for chronic plantar fasciitis fails, often a corticosteroid injection is given. Corticosteroid injection gives temporarily pain reduction, but no healing. Blood platelets initiate the natural healing rate. GPS(R) gives an eightfold concentrate platelets of patients own blood. Injection of these platelets in the attachment of the fascia to the os calcis might induce a healing rate.