Clinical trial NCT04709484: Comparison of the Effectiveness of USG and Palpation Guidance Steroid Injection in Patients With Plantar Fasciitis
Official title: Comparison of the Effectiveness of USG and Palpation Guidance Steroid Injection in Patients With Plantar Fasciitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fasciitis
Keywords: Plantar Fasciitis
USG
Steroid
Injection
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Severity
timeFrame: day 0 (before intervention)
measure: Pain Severity
timeFrame: 1 month after intervention
measure: Pain Severity
timeFrame: 3 month after intervention
Secondary outcomes:
measure: Foot Function Index
timeFrame: day 0 (before intervention)
measure: Foot Function Index
timeFrame: 1 month after intervention
measure: Foot Function Index
timeFrame: 3 month after intervention
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Adem ERBİROL
Study officials:
affiliation: Egirdir Bone Joint Diseases Treatment And Rehabilitation Hospital
name: Adem Erbirol
role: STUDY_DIRECTOR
References: