Fasciitis, PlantarRPWTNCT06813105
Outcome After Radial Pressure Wave Therapy in Plantar Fasciitis.
An observational study of Fasciitis, Plantar and Fasciitis, Plantar, Chronic, run by Hospital Civil de Guadalajara at 1 site in Mexico.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Fasciitis, Plantar, Fasciitis, Plantar, Chronic
- How many people
- 19 participants
- Where
- 1 siteMexico
- Study dates
- 19 Nov 2024to 20 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280
About this study
Official title: Exploratory Analysis of Pain and Function Improvement After Radial Pressure Wave Therapy in Plantar Fasciitis.
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.
Read the detailed description
Background: Plantar fasciitis (PF) is a common cause of heel pain, significantly impairing functionality and quality of life. Radial pressure wave therapy (RPWT) has emerged as a non-invasive therapeutic option. However, there is limited evidence regarding factors that may influence clinical outcomes in patients receiving this treatment.
Objectives: The primary objective of this study is to explore potential associations between baseline patient characteristics (such as age, body mass index, and pain intensity) and clinical outcomes in patients with PF treated with RPWT. Additionally, this study aims to assess changes in pain intensity and functionality following RPWT.
Materials and Methods: This is an exploratory, pilot observational study including patients diagnosed with PF who undergo three sessions of RPWT. The study evaluates changes in pain intensity, assessed using the Numerical Pain Rating Scale (NPRS), and functionality, measured using the WHODAS 2.0. Patient characteristics such as age, body mass index (BMI), and PF chronicity are collected retrospectively from medical records. Statistical analyses will be conducted to examine potential associations between patient characteristics and treatment outcomes.
- Conditions
- Fasciitis, Plantar, Fasciitis, Plantar, Chronic
- Keywords
- plantar fasciitis, rehabilitation outcomes
- Medical subject headings
- Fasciitis, Plantar
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: Immediately after the last RPWT session, approximately 1 week after baseline.
Secondary outcomes (1)
Functionality assessed by the WHODAS 2.0 scale.
Functionality will be evaluated using the WHODAS 2.0, a 12-item questionnaire assessing six domains of disability (cognition, mobility, self-care, interpersonal relationships, life activities, and community participation). Each item is rated on a 5-point scale, where higher scores indicate greater disability.
Measured: Immediately after the last RPWT session, approximately 1 week after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start19 Nov 2024
- Primary completion26 Dec 2024
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fasciitis, PlantarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Civil de Guadalajara
- Sponsor type
- University, hospital or other
- Collaborators
- University of Guadalajara
- Responsible party
- Principal investigator, Armando Tonatiuh Avila Garcia, Hospital Civil de Guadalajara
- Investigators
- ARMANDO TONATIUH AVILA GARCIA, MD, Principal investigator, Hospital Civil de Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813105
- Sponsor's protocol ID
- CEI 255/24
- Acronym
- RPWT
- Status last verified
- Feb 2025
- First submitted
- 24 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34038642Li 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.
PubMed 31435724Vahdatpour 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.
PubMed 23826009Charles 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.
PubMed 37662911
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Analysis of Pain and Function Improvement After Radial Pressure Wave Therapy in Plantar Fasciitis.
- ClinicalTrials.gov ID
- NCT06813105
- Acronym / sponsor ID
- RPWT / CEI 255/24
- Conditions
- Fasciitis, Plantar, Fasciitis, Plantar, Chronic
- Keywords
- plantar fasciitis, rehabilitation outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hospital Civil de GuadalajaraUniversity, hospital or other
- Collaborators
- University of Guadalajara
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 26 Dec 2024 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Plantar fasciitis (PF) is a common cause of heel pain, significantly impairing functionality and quality of life. Radial pressure wave therapy (RPWT) has emerged as a non-invasive therapeutic option. However, there is limited evidence regarding factors that may influence clinical outcomes in patients receiving this treatment.
Objectives: The primary objective of this study is to explore potential associations between baseline patient characteristics (such as age, body mass index, and pain intensity) and clinical outcomes in patients with PF treated with RPWT. Additionally, this study aims to assess changes in pain intensity and functionality following RPWT.
Materials and Methods: This is an exploratory, pilot observational study including patients diagnosed with PF who undergo three sessions of RPWT. The study evaluates changes in pain intensity, assessed using the Numerical Pain Rating Scale (NPRS), and functionality, measured using the WHODAS 2.0. Patient characteristics such as age, body mass index (BMI), and PF chronicity are collected retrospectively from medical records. Statistical analyses will be conducted to examine potential associations between patient characteristics and treatment outcomes.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain intensity assessed by the Numerical Pain Rating Scale (NPRS).
Time frame: Immediately after the last RPWT session, approximately 1 week after baseline.
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."
1 secondary outcome
Functionality assessed by the WHODAS 2.0 scale.
Time frame: Immediately after the last RPWT session, approximately 1 week after baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Background: PubMed 34038642Melese 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.
- Background: PubMed 31435724Li 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.
- Background: PubMed 23826009Vahdatpour 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.
- Results publication: PubMed 37662911Charles 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ARMANDO TONATIUH AVILA GARCIA, MD principal investigator
Hospital Civil de Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fasciitis, Plantar and Fasciitis, Plantar, Chronic, run by Hospital Civil de Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity assessed by the Numerical Pain Rating Scale (NPRS). (time frame: Immediately after the last RPWT session, approximately 1 week after baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06813105, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.