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

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. ^{1 2 3 4 5}

What 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. ^{1 2 4 5 6}

Is 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. ^{1 2 3 5 7}

Research Team

Donald S Malay, DPM

Principal Investigator

Penn Presbyterian Medical Center

Eligibility 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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Corticosteroid injection for plantar heel pain: a systematic review and meta-analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effect of corticosteroids over plantar fascia thickness in plantar fasciitis: a systematic review and meta-analysis. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

The comparison of the effect of corticosteroids and platelet-rich plasma (PRP) for the treatment of plantar fasciitis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of Botulinum Toxin A, Corticosteroid, and Anesthetic Injection for Plantar Fasciitis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Steroid injection for inferior heel pain: a randomised controlled trial. [2022]

6. Malaysia pubmed.ncbi.nlm.nih.gov

Unexpected sequelae of plantar fasciitis: Iatrogenic calcaneal osteomyelitis following plantar heel injection. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Use of platelet rich plasma to treat plantar fasciitis: design of a multi centre randomized controlled trial. [2021]