Clinical trial NCT04709484
Conditions: Plantar Fasciitis
Keywords: Plantar Fasciitis USG Steroid Injection
Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Start date: 2021-03-11; Completion date: 2021-08-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: 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. arm 2: 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.
Interventions: intervention 1: USG-guided steroid injection intervention 2: Palpation-guided steroid injection
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol documents:
Prot_000.pdf: 
Comparison of the Effectiveness of USG and Palpation Guidance Steroid Injection in 
Patients With Plantar Fasciitis 
NCT04709484 – 01.03.2021 
66 (sixty­six) patients were included  in the study. Patients diagnosed with plantar fasciitis, 
aged between 18­75 years, with failure of conservative treatment (stretching exercises, non­ 
steroidal  anti­inflammatory  drugs  and  heel  pads)  for  at  least  3  months,  with  a  Visual 
Analogue  Scale  value  of  5  and  above  were  included  in  the  study.  Receiving  any  local 
injection  therapy  and  physical  therapy  for  heel  pain  in  the  last  4  months,  any  history  of 
surgery for heel pain, history of tarsal tunnel syndrome, ankle effusion showing intra­articular 
disease,  old  healed  calcaneal  fracture,  Achilles  tendinopathy,  foot  and  foot  any  wrist 
deformity, planus or pes cavus deformity; Patients with systemic disorders such as diabetes 
mellitus,  rheumatoid  arthritis,  hematological  disease  or  gout,  pregnancy,  recent  history  of 
aspirin or aspirin­like medication, and mental disability were excluded from the study. 
 
 
In  the  study,  patients'  Visual  Analogue  Scale  (VAS)  and  Foot  Function  Index  (FFI) 
questionnaires  were  filled.  Patients  were  randomized  into  2  groups  according  to  Random 
Number Generation. The first group was designed as the USG guided steroid injection group, 
and the second group was designed as the palpation guided steroid injection group. 34 patients 
were included  in the 1st  group and 32 patients in the 2nd group. The patients in the USG 
group were injected with steroids to the thickened area of the fascia under USG guidance. In 
the palpation guided practice, the most painful point was found by palpation of the calcaneus 
bone and steroid injection was made to that part. The content of the steroid solution was 1 ml 
of 1% Lidocaine + 1 ml (40  mg) of  methylprednisolone. There will  be pre­injection, post­ 
injection 1st and 3rd month controls. 

SAP_001.pdf: 
Comparison of the Effectiveness of USG and Palpation Guidance Steroid Injection in 
Patients With Plantar Fasciitis 
  NCT04709484 – 01.08.2021 
 
Statistical Analysis 
Statistical  analyses  were  done  using  SPSS  version  20  statistical  software  (IBM  Corp., 
Armonk, NY). Average, standard deviation and frequency were used as descriptive statistical 
methods. Shapiro­Wilk and Kolmogorov­Smirnov tests were used to evaluate the distribution 
of numerical data. Since the data were not suitable for normal distribution, Mann­Whitney U 
test was used to measure the difference between the groups and Willcoxon test was used to 
measure  the  temporal  process.  Bonferroni  test  was  used  to  detect  important  differences. 
Pearson Chi Square test was used for the differences between discrete variables. The results 
were evaluated at a 95% confidence interval and p <0.05 significance level.