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"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."

"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."

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06589037
Acronym
SW-PF-BL
Enrollment
48
Registered
2024-09-19
Start date
2024-10-01
Completion date
2025-05-01
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plantar Fasciitis

Keywords

plantar fasciitis, shockwaves, sciatic nerve.

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 < 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 < .05.

Interventions

OTHERshock wave treatment control group

The control group, consisting of 24 people, will receive shock wave treatment on the sole of the foot to treat plantar fasciitis. There will be 4 sessions and 4 data collections.

OTHERshock wave treatment experimental group

The experimental group, consisting of 24 people, will receive shockwave treatment on the back of the leg to treat plantar fasciitis. There will be 4 sessions and 4 data collections.

Sponsors

University of Alcala
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
pain (EVA scale)3 monthsAssess changes in pain in plantar fasciitis after treatments
ankle-foot functionality (FFI)3 monthsassess the improvement in ankle-foot functionality after treatment.
quality of life (SF12)3 monthsassess the improvement in the patient's quality of life after treatment.

Countries

Spain

Contacts

Primary ContactPaula Fernandez-Martin
paula.fernandezmarti@edu.uah.es+34682653285

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026