Clinical trial NCT06589037: &#34;Comparison of Shockwave Application on the Sole of the Foot Vs. the Back of the Leg in the Treatment of Plantar Fasciitis: a Clinical Trial.&#34;
Official title: &#34;Comparison of Shockwave Application on the Sole of the Foot Vs. the Back of the Leg in the Treatment of Plantar Fasciitis: a Clinical Trial.&#34;
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Plantar Fasciitis
Keywords: plantar fasciitis, shockwaves, sciatic nerve.
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Forty-eight subjects who meet the inclusion criteria will be recruited and randomly assigned to each intervention group. The control group will receive local shock wave therapy, while the experimental group will receive shock wave therapy along the course of the sciatic nerve.
Primary purpose: TREATMENT

Brief summary: The study focuses on plantar fasciitis, one of the most common causes of non-traumatic foot and ankle pain, with an estimated prevalence of 10%. Its objective is to evaluate the effectiveness of shock wave therapy applied along the course of the sciatic nerve in treating plantar fasciitis, comparing its effects on pain, foot-ankle functionality, and quality of life.

Forty-eight subjects will be recruited and randomly assigned to two groups: one will receive local shock wave therapy, while the other will receive therapy along the sciatic nerve. Data will be collected at four points in time: before the intervention, one week after, one month after, and three months after, with blinded data collection.

Pain, foot-ankle functionality, and quality of life will be measured. Data analysis will be performed using SPSS 29.0, applying ANOVA and other tests depending on the normality of the data. Differences will be estimated with a 95% confidence interval and a p-value \&lt; 0.05.

Detailed description: Introduction: Plantar fasciitis is one of the most common causes of non-traumatic ankle-foot pain. The exact prevalence is unknown, but it is estimated to be around 10%.

Objective: To evaluate the efficacy of applying shock waves along the course of the sciatic nerve in the treatment of plantar fasciitis and its effect on pain, as well as to assess changes in ankle-foot functionality and quality of life.

Material and Methods: Forty-eight subjects who meet the inclusion criteria will be recruited and randomly assigned to each intervention group. The control group will receive local shock wave therapy, while the experimental group will receive shock wave therapy along the course of the sciatic nerve.

Data Collection: Data will be collected at four different times: before the intervention, one week after, one month after, and three months after. The data collection will be carried out by a team member who will be blinded to the group to which the subject belongs. The dependent variables to be measured are pain (VAS scale), ankle-foot functionality (FFI), and quality of life (SF12).

Data Analysis: The data analysis will use SPSS 29.0. Normality of variables will be assessed, and descriptive analyses will be conducted. Initial homogeneity between groups will be compared, and ANOVA and other tests will be applied according to normality and homoscedasticity. Differences and percentage changes will be calculated, estimating effect size, with a 95% CI and p \&lt; .05.

Eligibility criteria: Inclusion criteria: having been diagnosed with plantar fasciitis, experiencing pain related to the condition for at least 1 month, and being between 18 and 65 years of age.

Exclusion criteria: being pregnant, having a pacemaker, presenting with rheumatoid arthritis, or having coagulation disorders.

Primary outcomes:
measure: pain (EVA scale)
timeFrame: 3 months
measure: ankle-foot functionality (FFI)
timeFrame: 3 months
measure: quality of life (SF12)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alcala de Henares
country: Spain
facility: Campus Cientifico -Tecnológico UAH. Av. de León, 3A.
state: Madrid
Study officials:
affiliation: University of Alcala
name: Paula Fernandez-Martin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bicer M, Hocaoglu E, Aksoy S, Inci E, Aktas I. Assessment of the Efficacy of Extracorporeal Shockwave Therapy for Plantar Fasciitis with Magnetic Resonance Imaging Findings. J Am Podiatr Med Assoc. 2018 Mar;108(2):100-105. doi: 10.7547/15-106.