Steroid Injections for Plantar Fasciitis

(PF-RCT Trial)

Overseen By Raafae Hussain, DPM

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must not be taking: Analgesics, Anti-seizure, Neuroleptics

Disqualifiers: Drug dependence, Chronic pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 day

62 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods of administering steroid injections to treat plantar fasciitis, a common cause of heel pain. The goal is to determine which method offers better pain relief and improves foot function. Researchers will compare ultrasound-guided injections to those guided by anatomical landmarks. Individuals experiencing heel pain when pressing on the bottom of their foot, possibly with a bone spur, might be suitable for this study. As an unphased trial, participants have the opportunity to contribute to advancing treatment options for plantar fasciitis.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that using ultrasound to guide corticosteroid injections safely treats plantar fasciitis. Recipients of these injections experienced short-term pain relief without major side effects. Research indicates that this method can be more effective than injections given without ultrasound guidance.

For the anatomical injection method, studies have demonstrated that corticosteroid injections significantly reduce pain. Most people find these injections safe and well-tolerated.

Both methods use a similar mix of medications, including dexamethasone and triamcinolone, common steroids. These medications are generally safe for conditions like plantar fasciitis. Overall, both approaches effectively reduce heel pain with minimal risk of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for plantar fasciitis because they explore two different methods of delivering steroid injections, potentially offering more precise options. The Ultrasound Guided Injection (USGI) uses real-time imaging to target the painful area with high accuracy, possibly improving outcomes by ensuring the medication reaches exactly where it's needed. On the other hand, the Anatomical Injection provides a simpler approach that could be more accessible in various clinical settings while still aiming to effectively relieve pain. Both methods involve a combination of bupivacaine, dexamethasone, and triamcinolone acetamide, which are proven medications for reducing inflammation and pain. These approaches might offer quicker relief compared to traditional treatments like physical therapy or oral medications.

What evidence suggests that this trial's treatments could be effective for plantar fasciitis?

Research shows that steroid injections can help reduce pain for people with plantar fasciitis. In this trial, participants will receive either ultrasound-guided injections or anatomically-guided injections. Studies have found that ultrasound-guided injections result in better pain relief and improved foot function over several weeks. One study showed that about one in three people experienced significant pain relief from ultrasound-guided injections after four weeks. Injections guided by touch, without ultrasound, also significantly reduce pain. Overall, both methods of administering steroid injections effectively reduce heel pain. ^{1 5 6 7 8}

Who Is on the Research Team?

Donald S Malay, DPM

Principal Investigator

Penn Presbyterian Medical Center

Are You a Good Fit for This Trial?

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

You have diabetes, but you don't have nerve damage related to it.

Male or non-pregnant female of any ethnicity or race

You have pain in the heel area and may have a bone spur that can be seen on an X-ray.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ultrasound-guided or anatomic topography-guided corticosteroid injections for plantar fasciitis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in VAS pain score and foot-related quality of life

12 months

Follow-up visits at 3, 6, 9, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Anatomical Guided injection
• Local Steroid Injection into the plantar heel
• Ultrasound Guided Injection

Trial Overview 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.

How Is the Trial Designed?

Group I: Ultrasound Guided Injection Experimental Treatment 2 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 injection Active Control 2 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 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

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

A rare case of chronic calcaneal osteomyelitis developed in a 56-year-old woman following a corticosteroid injection for plantar fasciitis, highlighting the potential risks associated with this treatment despite its general safety.

The study suggests that plantar heel injections should be performed in controlled environments, like operating theaters, and recommends considering platelet-rich plasma (PRP) injections instead of corticosteroids due to better safety profiles, especially after conservative treatments have failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unexpected sequelae of plantar fasciitis: Iatrogenic calcaneal osteomyelitis following plantar heel injection. Mohd Khalid, SA., Bajuri, MY.[2020]

Corticosteroid injections showed short-term effectiveness in reducing pain compared to autologous blood injections and foot orthoses in a systematic review of 47 trials involving 2989 participants.

However, corticosteroid injections were not more effective than placebo for pain relief or functional improvement, indicating that their benefits may be limited and further high-quality studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corticosteroid injection for plantar heel pain: a systematic review and meta-analysis. Whittaker, GA., Munteanu, SE., Menz, HB., et al.[2022]

A systematic review of 17 randomized controlled trials involving 1109 subjects found that corticosteroid injections do not significantly reduce the thickness of the plantar fascia in patients with plantar fasciitis.

The study also showed that corticosteroid injections provided no greater pain relief compared to other active treatments, indicating they may not be the most effective option for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of corticosteroids over plantar fascia thickness in plantar fasciitis: a systematic review and meta-analysis. Peña-Martínez, VM., Acosta-Olivo, C., Simental-Mendía, LE., et al.[2023]

A randomized controlled trial will compare the effectiveness of corticosteroid injections versus autologous platelet concentrate injections in treating chronic plantar fasciitis, involving 120 patients over a year.

The study aims to assess pain and function improvements at multiple time points, with the hypothesis that platelet injections may promote healing rather than just temporary pain relief, as seen in previous literature on tendinosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of platelet rich plasma to treat plantar fasciitis: design of a multi centre randomized controlled trial. Peerbooms, JC., van Laar, W., Faber, F., et al.[2021]

In a study involving 60 patients with plantar fasciitis, both platelet-rich plasma (PRP) and corticosteroid injections significantly reduced heel pain after treatment, with no significant difference in effectiveness between the two methods.

PRP injections may be a safer alternative to corticosteroids, as they avoid potential complications associated with steroid use while providing similar pain relief outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The comparison of the effect of corticosteroids and platelet-rich plasma (PRP) for the treatment of plantar fasciitis. Akşahin, E., Doğruyol, D., Yüksel, HY., et al.[2022]

Steroid injections significantly reduced heel pain in patients with plantar fasciitis compared to placebo, with improvements observed at both 6 and 12 weeks after treatment.

There was no significant difference in pain relief between ultrasound-guided and unguided steroid injections, indicating that both methods are effective for reducing plantar fascia thickness and pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Steroid injection for inferior heel pain: a randomised controlled trial. Ball, EM., McKeeman, HM., Patterson, C., et al.[2022]

In a randomized, controlled trial involving 78 patients with plantar fasciitis, all three treatment groups (local anesthetic, corticosteroid, and botulinum toxin A) showed significant clinical improvement in pain and function over 6 months, with no significant differences between the groups.

Ultrasonographic evaluations indicated that the thickness of the plantar fascia decreased and ankle dorsiflexion improved for all patients, suggesting that all treatments were effective in managing plantar fasciitis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Botulinum Toxin A, Corticosteroid, and Anesthetic Injection for Plantar Fasciitis. Elizondo-Rodríguez, J., Simental-Mendía, M., Peña-Martínez, V., et al.[2022]

Citations

1. mdpi.com mdpi.com/2075-1729/15/7/1107

Comparison of Effectiveness Between Ultrasound-Guided ... The effectiveness of ultrasound (US)-guided compared with blind corticosteroid injections for the treatment of plantar fasciitis (PF) remains uncertain.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4545130/

The effectiveness of corticosteroid injection in the treatment of ... All placebo-controlled RCTs showed a significant reduction in pain with the use of corticosteroid injections.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6481652/

Injected corticosteroids for treating plantar heel pain in adults They can also inhibit fibroblast proliferation and ground substance proteins, both of which may help in the treatment of plantar fasciitis (McMillan 2010). Why ...

4. jospt.org jospt.org/doi/10.2519/jospt.2019.8807

Effectiveness of Foot Orthoses Versus Corticosteroid ... Foot orthoses and corticosteroid injection are effective treatments for plantar heel pain; however, it is unclear whether one is more effective than the other.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03231150

Plantar Fasciitis Randomized Clinical Control 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), ...

6. emedicine.medscape.com emedicine.medscape.com/article/86143-treatment

Plantar Fasciitis Treatment & Management One study found that ultrasound (US)-guided steroid injection provided short-term relief from pain in plantar fasciitis for up to 4 weeks ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12150543/

Does local steroid injection have a prognostic value for ... Patients who experienced temporary improvement after local corticosteroid injection had better clinical outcomes following endoscopic plantar fascia release.

8. rapm.bmj.com rapm.bmj.com/content/early/2025/02/26/rapm-2024-105656

Use and safety of corticosteroid injections in joints and ... This guideline focuses on the safety and efficacy of corticosteroid joint injections for managing joint chronic pain in adults.