Comparison of the Effectiveness of USG and Palpation Guidance Steroid Injection in Patients With Plantar Fasciitis

Plantar fasciitis, often described as overloading of the plantar fascia, is the most common cause of heel pain in adults. It is characterized by a sharp pain along the medial aspect of the heel, which is worse with the first step taken in the morning or at the beginning of an activity and decreases as the person warms up. The etiology of plantar fasciitis is multifactorial and not well understood. Poor biomechanics and changes in the structure of the foot can lead to repeated micro-trauma at the beginning of the plantar fascia, causing inflammation and degeneration. Plantar fasciitis is more common in sedentary individuals and athletes and those participating in running sports. Other risk factors associated with plantar fasciitis include reduced ankle dorsiflexion, increased body mass index (BMI), and work-related weight loss activities.

Current treatments for plantar fasciitis, such as plantar fascia stretching exercises, strapping, extracorporeal shock wave therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), arch braces, and heel pads are mainly aimed at reducing inflammation. Corticosteroid injections are usually reserved for refractory plantar fasciitis after conservative noninvasive attempts have failed. It has been shown to effectively reduce heel pain in patients with plantar fasciitis. The strong anti-inflammatory effect of corticosteroids can speed up the process of pain relief.

In our study, we aimed to compare the effectiveness of USG and palpation guidance blind steroid injection in patients diagnosed with plantar fasciitis.

Study Overview

• Status: Completed
• Conditions: Plantar Fasciitis
• Intervention / Treatment: Drug: USG-guided steroid injection; Drug: Palpation-guided steroid injection

Detailed Description

It is planned to enroll 60 (sixty) patients in the study. Patients diagnosed with plantar fasciitis, between the ages of 18-75, who have failed conservative treatment (stretching exercises, non-steroidal anti-inflammatory drugs and heel pads) for at least 3 months, and those with a Visual Anolog Scale value of 5 and above will be included in the study. Any local injection therapy and physical therapy for heel pain in the last 4 months, any surgery history for heel pain, history of tarsal tunnel syndrome, ankle effusion showing intra-articular disease, healed calcaneal fracture, Achilles tendinopathy, foot including pes and any deformity of the ankle, planus or pes cavus deformity; Patients with systemic disorders such as diabetes mellitus, rheumatoid arthritis, hematological disease or gout, pregnancy, history of aspirin or aspirin-like medication, and mental insufficiency will be excluded from the study.

In the study, the patients will be filled in Visual Analogue Scale (VAS) and Foot Function Indez (FFI) questionnaires. Patients will be randomized into 2 groups according to the Random Number Generation. The first group will be the USG-guided steroid injection group, and the second group will be the palpation-guided steroid injection group. In the USG-guided group, steroid injection will be made to the area where the fascia is thickened under the guidance of USG. In the palpation-guided group, the most painful point will be found by palpation on the calcaneus bone and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone. There will be pre-injection, 1st month and 3rd month controls after injection.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Isparta, Turkey
    • Adem ERBİROL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients diagnosed with plantar fasciitis
2. Between the ages of 18-75
3. Who have failed conservative treatment (stretching exercises, non-steroidal anti-inflammatory drugs and heel pads) for at least 3 months
4. Visual Anolog Scale value of 5 and above will be included in the study.

Exclusion Criteria:

1. Having received any local injection therapy and physical therapy for heel pain within the last 4 months,
2. Any history of surgery for heel pain, tarsal tunnel syndrome, calcaneal fracture, Achilles tendinopathy, any deformity of the foot and ankle including pes, planus or pes cavus deformity
3. with systemic disorders such as diabetes mellitus, rheumatoid arthritis, hematological disease, or gout
4. Pregnancy
5. A recent history of aspirin or aspirin-like medication
6. mental disability

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: USG-guided steroid injection group; In the USG-guided group, steroid injection will be made to the area where the fascia is thickened under USG guidance. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.	Drug: USG-guided steroid injection; In the palpation-guided group, the most painful point will be found by palpation on the calcaneus boIn the USG-guided group, steroid injection will be made to the area where the fascia is thickened under USG guidance. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.ne and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.; Other Names: no other names
EXPERIMENTAL: Palpation-guided steroid injection group; In the palpation-guided group, the most painful point will be found by palpation on the calcaneus bone and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.	Drug: Palpation-guided steroid injection; In the palpation-guided group, the most painful point will be found by palpation on the calcaneus bone and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.; Other Names: no other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Severity	visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain. Higher values represent a worse outcome.	day 0 (before intervention)
Pain Severity	visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain. Higher values represent a worse outcome.	1 month after intervention
Pain Severity	visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain. Higher values represent a worse outcome.	3 month after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot Function Index	Foot Function Index(FFI) is a self-report questionnaire concerning foot function and pain. The FFI consists of 23 questions with scores 0-10 in three domains concerning foot pain, function and disability resulting in a total score range from 0 to 230. The score is validated for patients with plantar fasciitis with a minimal clinical important difference being 7 points. Higher values represent a worse outcome.	day 0 (before intervention)
Foot Function Index	Foot Function Index(FFI) is a self-report questionnaire concerning foot function and pain. The FFI consists of 23 questions with scores 0-10 in three domains concerning foot pain, function and disability resulting in a total score range from 0 to 230. The score is validated for patients with plantar fasciitis with a minimal clinical important difference being 7 points. Higher values represent a worse outcome.	1 month after intervention
Foot Function Index	Foot Function Index(FFI) is a self-report questionnaire concerning foot function and pain. The FFI consists of 23 questions with scores 0-10 in three domains concerning foot pain, function and disability resulting in a total score range from 0 to 230. The score is validated for patients with plantar fasciitis with a minimal clinical important difference being 7 points. Higher values represent a worse outcome.	3 month after intervention

Collaborators and Investigators

• Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Investigators: Study Director: Adem Erbirol, Egirdir Bone Joint Diseases Treatment And Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 11, 2021
• Primary Completion (ACTUAL): June 1, 2021
• Study Completion (ACTUAL): August 1, 2021

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (ACTUAL): January 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 18, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Steroid; Injection; Plantar Fasciitis; USG
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: dr.ademerbirol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: other researchers would get information from the main researcher. therefore it was not shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No