"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."

NCT06589037 | Not Yet Recruiting

• 1 other identifier: Shockwave Application in PF
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fasciitis

Keywords

plantar fasciitis, shockwaves, sciatic nerve.

Outcome Measures

Primary Outcomes (3)

• pain (EVA scale)

  Assess changes in pain in plantar fasciitis after treatments

  3 months

• ankle-foot functionality (FFI)

  assess the improvement in ankle-foot functionality after treatment.

  3 months

• quality of life (SF12)

  assess the improvement in the patient\'s quality of life after treatment.

  3 months

Study Arms (2)

experimental group

EXPERIMENTAL

A group of 24 people receive shock waves along the leg to treat their plantar fasciitis.

Other: shock wave treatment experimental group

Control group

ACTIVE COMPARATOR

A group of 24 people receive shock waves on the sole of the foot to treat their plantar fasciitis

Other: shock wave treatment control group

Interventions

shock wave treatment control group OTHER

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.

Control group

shock wave treatment experimental group OTHER

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.

experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Campus Cientifico -Tecnológico UAH. Av. de León, 3A.

Alcalá de Henares, Madrid, 28804, Spain

Location

Related Publications (1)

• 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.

  PMID: 29634309 BACKGROUND

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Paula Fernandez-Martin

  University of Alcala

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paula Fernandez-Martin

CONTACT

+34682653285; paula.fernandezmarti@edu.uah.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: graduate university degree

Model Details: 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.

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: May 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)