Outcome After Radial Pressure Wave Therapy in Plantar Fasciitis.

NCT06813105 | Completed DMC

• 1 other identifier: CEI 255/24
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to explore potential associations between baseline patient characteristics (such as age, body mass index, and baseline pain intensity) and clinical outcomes in patients with plantar fasciitis undergoing radial pressure wave therapy (RPWT). The study includes male and female adults aged 18 to 60 years.

Conditions

Fasciitis, Plantar; Fasciitis, Plantar, Chronic

Keywords

plantar fasciitis; rehabilitation outcomes

Outcome Measures

Primary Outcomes (1)

• Pain intensity assessed by the Numerical Pain Rating Scale (NPRS).

  Pain intensity will be measured using the Numerical Pain Rating Scale (NPRS), a validated 10-point scale where 0 represents "no pain" and 10 represents "the worst pain imaginable."

  Immediately after the last RPWT session, approximately 1 week after baseline.

Secondary Outcomes (1)

• Functionality assessed by the WHODAS 2.0 scale.

  Immediately after the last RPWT session, approximately 1 week after baseline.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study focuses on adult patients diagnosed with plantar fasciitis (PF), a condition commonly affecting middle-aged individuals. Eligible participants are between 18 and 60 years old and present with symptoms persisting for at least three months before treatment. Given that risk factors such as body mass index (BMI) and physical activity levels may influence clinical outcomes, these characteristics will be documented for all participants. Additionally, data on prior conventional physical therapy and PF chronicity (acute vs. chronic cases) will be collected to explore potential associations with treatment response.

You may qualify if:

• Diagnosis of plantar fasciitis confirmed by clinical evaluation.
• Age 18 to 60 years.
• Symptoms persisting for at least three months before treatment.
• Completed three RPWT sessions using a standardized protocol (2000 impulses per session, 10 Hz, and 3.5 bar).
• Availability of complete medical records, including three-month follow-up data.

You may not qualify if:

• History of foot surgery or corticosteroid injection in the affected limb within the past six months.
• Pregnancy at the time of treatment.
• Presence of concurrent musculoskeletal conditions (e.g., fractures, active infections, sprains) in the affected limb.
• Diagnosis of systemic conditions (e.g., cancer, osteoporosis, autoimmune diseases).
• Incomplete medical records or failure to complete RPWT sessions and follow-up visits.

Sponsors & Collaborators

• Hospital Civil de Guadalajara: lead
• University of Guadalajara: collaborator

Study Sites (1)

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, 44280, Mexico

Location

Related Publications (4)

• Charles R, Fang L, Zhu R, Wang J. The effectiveness of shockwave therapy on patellar tendinopathy, Achilles tendinopathy, and plantar fasciitis: a systematic review and meta-analysis. Front Immunol. 2023 Aug 16;14:1193835. doi: 10.3389/fimmu.2023.1193835. eCollection 2023.

  PMID: 37662911 BACKGROUND

• Melese H, Alamer A, Getie K, Nigussie F, Ayhualem S. Extracorporeal shock wave therapy on pain and foot functions in subjects with chronic plantar fasciitis: systematic review of randomized controlled trials. Disabil Rehabil. 2022 Sep;44(18):5007-5014. doi: 10.1080/09638288.2021.1928775. Epub 2021 May 26.

  PMID: 34038642 BACKGROUND

• Li H, Xiong Y, Zhou W, Liu Y, Liu J, Xue H, Hu L, Panayi AC, Mi B, Liu G. Shock-wave therapy improved outcome with plantar fasciitis: a meta-analysis of randomized controlled trials. Arch Orthop Trauma Surg. 2019 Dec;139(12):1763-1770. doi: 10.1007/s00402-019-03262-z. Epub 2019 Aug 21.

  PMID: 31435724 BACKGROUND

• Vahdatpour B, Sajadieh S, Bateni V, Karami M, Sajjadieh H. Extracorporeal shock wave therapy in patients with plantar fasciitis. A randomized, placebo-controlled trial with ultrasonographic and subjective outcome assessments. J Res Med Sci. 2012 Sep;17(9):834-8.

  PMID: 23826009 BACKGROUND

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• ARMANDO TONATIUH AVILA GARCIA, MD

  Hospital Civil de Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 6, 2025
• Study Start: November 19, 2024
• Primary Completion: December 26, 2024
• Study Completion: January 20, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

ME (1)