Plantar FasciitisSW-PF-BLNCT06589037
"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."
A study testing shock wave treatment experimental group in people with Plantar Fasciitis, run by University of Alcala at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- shock wave treatment experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2024to 1 May 2025
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Campus Cientifico -Tecnológico UAH. Av. de León, 3A.
Alcalá de Henares, Madrid, 28804
Paula Fernandez-Martin, +34682653285, paula.fernandezmarti@edu.uah.es
About this study
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.
Read the 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.
- Conditions
- Plantar Fasciitis
- Being tested
- shock wave treatment control group, shock wave treatment experimental group
- Keywords
- plantar fasciitis, shockwaves, sciatic nerve.
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shock wave treatment control groupOther
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.
shock wave treatment experimental groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | A group of 24 people receive shock waves along the leg to treat their plantar fasciitis. Receives: 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 Receives: Other: shock wave treatment control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain (EVA scale)
Assess changes in pain in plantar fasciitis after treatments
Measured: 3 months
ankle-foot functionality (FFI)
assess the improvement in ankle-foot functionality after treatment.
Measured: 3 months
quality of life (SF12)
assess the improvement in the patient\'s quality of life after treatment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plantar FasciitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Fernández Martín, University of Alcala
- Investigators
- Paula Fernandez-Martin, Principal investigator, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589037
- Sponsor's protocol ID
- Shockwave Application in PF
- Acronym
- SW-PF-BL
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29634309
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "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."
- ClinicalTrials.gov ID
- NCT06589037
- Acronym / sponsor ID
- SW-PF-BL / Shockwave Application in PF
- Conditions
- Plantar Fasciitis
- Keywords
- plantar fasciitis, shockwaves, sciatic nerve.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 19 Sep 2024 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: shock wave treatment experimental groupA group of 24 people receive shock waves along the leg to treat their plantar fasciitis. |
| Control group | Active comparator | Other: shock wave treatment control groupA group of 24 people receive shock waves on the sole of the foot to treat their plantar fasciitis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shock wave treatment control groupThe 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. | Other | Control group |
| shock wave treatment experimental groupThe 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. | Other | experimental group |
Primary outcome
pain (EVA scale)
Time frame: 3 months
Assess changes in pain in plantar fasciitis after treatments
ankle-foot functionality (FFI)
Time frame: 3 months
assess the improvement in ankle-foot functionality after treatment.
quality of life (SF12)
Time frame: 3 months
assess the improvement in the patient\'s quality of life after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 29634309Bicer 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.
- Individual participant dataSharing planned: No
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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.
Paula Fernandez-Martin principal investigator
University of Alcala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shock wave treatment experimental group in people with Plantar Fasciitis, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paula Fernandez-Martin (+34682653285, paula.fernandezmarti@edu.uah.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain (EVA scale) (time frame: 3 months). The study lists 3 primary outcomes in all. 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 NCT06589037, which also lists 1 linked publication.
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 19 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.