Chronic Refractory Plantar FasciopathyNCT07654660
Multimodal Conservative Intervention Versus Surgery for Chronic Refractory Plantar Fasciopathy
A study testing Multimodal Conservative Intervention and Endoscopic Plantar Fascial Release in people with Chronic Refractory Plantar Fasciopathy, run by Universidad Europea de Valencia at 1 site in Spain.
Trial summary
Chronic refractory plantar fasciopathy is a common musculoskeletal condition that can cause persistent heel pain and functional limitations despite conservative treatment. When symptoms do not improve, patients often face the decision between continuing non-surgical management or undergoing surgery. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Chronic Refractory Plantar Fasciopathy
- What is being tested?
- Multimodal Conservative Intervention and Endoscopic Plantar Fascial Release
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 30 to 65 years.
- Diagnosis of chronic refractory plantar fasciopathy with symptom duration greater than 6 months.
- Failure of at least two previous conservative treatments, each lasting at least 12 weeks.
- Foot Function Index (FFI) total score ≥45 points.
- Resting pain intensity ≥4/10 on the Visual Analog Scale (VAS).
- Plantar fascia thickness ≥4 mm at the calcaneal insertion confirmed by ultrasound.
- Ability to provide written informed consent and comply with study procedures.
Who cannot join
- Previous foot surgery on the affected side.
- Calcaneal stress fracture.
- Glycated hemoglobin (HbA1c) >7.5%.
- Inability or unwillingness to comply with study procedures or follow-up assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
European University of Valencia
Valencia, Valencia, 46010
Javier Bonastre Férez, PhD, +34644120315, javier.bonastre@universidadeuropea.es
About this study
Official title: Study Protocol for a Multicenter Controlled Trial Comparing Multimodal Conservative Intervention Versus Surgical Management in Chronic Refractory Plantar Fasciopathy
Chronic refractory plantar fasciopathy is a common musculoskeletal condition that can cause persistent heel pain and functional limitations despite conservative treatment. When symptoms do not improve, patients often face the decision between continuing non-surgical management or undergoing surgery. However, direct comparative evidence between these treatment strategies is limited.
This multicenter controlled trial aims to compare the effectiveness of a multimodal conservative intervention consisting of manual therapy and ultrasound-guided percutaneous neuromodulation with endoscopic plantar fascial release followed by standard postoperative rehabilitation in adults with chronic refractory plantar fasciopathy.
A total of 120 participants will be allocated to treatment groups according to their informed treatment preference within a shared decision-making process. The primary outcome will be the change in the Foot Function Index (FFI) after 6 weeks. Secondary outcomes include pain intensity, health-related quality of life, treatment adherence, adverse events, and exploratory neurophysiological measures. The results are expected to provide evidence to support clinical decision-making and optimize the management of patients with chronic refractory plantar fasciopathy.
Read the detailed description
Chronic refractory plantar fasciopathy is one of the most common causes of persistent heel pain and is associated with substantial disability, reduced quality of life, and limitations in daily and occupational activities. Although most patients respond to conservative management, a subgroup continues to experience symptoms despite prolonged treatment and may be considered for surgical intervention. However, evidence directly comparing optimized multimodal conservative care with surgical management remains limited.
This multicenter, non-randomized controlled trial has been designed to evaluate the comparative effectiveness of these two therapeutic strategies under real-world clinical conditions. Participants will be allocated to treatment groups according to their informed treatment preference following a standardized shared decision-making process.
The experimental group will receive a 6-week multimodal conservative intervention consisting of manual therapy techniques and ultrasound-guided percutaneous neuromodulation delivered in 12 supervised sessions. The control group will undergo endoscopic plantar fascial release followed by a standardized postoperative rehabilitation program.
The primary outcome measure is the change in the Foot Function Index (FFI) at 6 weeks after treatment initiation. Secondary outcomes include pain intensity measured using the Visual Analog Scale (VAS), health-related quality of life assessed with the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L), treatment adherence, adverse events, and exploratory neurophysiological assessment through electromyography.
To minimize the effects of treatment selection bias inherent to the non-randomized design, analyses will include adjusted analysis of covariance (ANCOVA) and inverse probability of treatment weighting (IPTW). The findings of this study are expected to provide clinically relevant evidence to support shared decision-making and optimize treatment selection for patients with chronic refractory plantar fasciopathy.
- Conditions
- Chronic Refractory Plantar Fasciopathy
- Being tested
- Multimodal Conservative Intervention, Endoscopic Plantar Fascial Release
- Keywords
- Plantar Fasciopathy, Plantar Fasciitis, Manual Therapy, Percutaneous Neuromodulation, Endoscopic Plantar Fasciotomy, Foot Function Index, Heel Pain, Conservative Treatment, Rehabilitation, Comparative Effectiveness
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Conservative InterventionProcedure or surgery
A 6-week multimodal conservative treatment including manual therapy techniques (gastrocnemius stretching, transverse friction massage, and tibial nerve neurodynamic mobilization) combined with ultrasound-guided percutaneous neuromodulation of the posterior tibial nerve using low-frequency electrical stimulation.
Endoscopic Plantar Fascial ReleaseProcedure or surgery
Endoscopic plantar fascial release performed using a standardized surgical technique followed by a standardized postoperative rehabilitation program.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Conservative Intervention | Experimental | Participants assigned to this arm will receive a 6-week multimodal conservative intervention consisting of manual therapy techniques combined with ultrasound-guided percutaneous neuromodulation, delivered in 12 supervised sessions (2 sessions per week). Receives: Procedure: Multimodal Conservative Intervention |
| Surgical Management | Active comparator | Participants assigned to this arm will undergo endoscopic plantar fascial release followed by a standardized postoperative rehabilitation program, including manual therapy during the rehabilitation period. Receives: Procedure: Endoscopic Plantar Fascial Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Foot Function Index (FFI) total score
The primary outcome is the change in the total Foot Function Index (FFI) score from baseline to 6 weeks after treatment initiation. The FFI is a validated patient-reported outcome measure assessing pain and functional disability related to foot disorders.
Measured: Baseline and 6 weeks
Secondary outcomes (4)
Change in pain intensity measured by the Visual Analog Scale (VAS)
Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS).
Measured: Baseline, 3 weeks, 6 weeks, and 12 weeks
Change in health-related quality of life assessed by the EQ-5D-5L
Health-related quality of life will be evaluated using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L).
Measured: Baseline, 6 weeks, and 12 weeks
Treatment adherence
Treatment adherence will be assessed as the proportion of scheduled sessions attended by participants.
Measured: During the 6-week intervention period
Incidence of adverse events
Adverse events will be recorded and classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: From baseline through 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study startDec 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Chronic Refractory Plantar FasciopathyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to one of two parallel intervention groups according to their informed treatment preference following a standardized shared decision-making process. One group will receive a multimodal conservative intervention consisting of manual therapy and ultrasound-guided percutaneous neuromodulation, while the other group will undergo endoscopic plantar fascial release followed by standardized postoperative rehabilitation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Javier Bonastre Férez, Universidad Europea de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654660
- Sponsor's protocol ID
- UEV-PF-MTPNM-2026-01
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At the time of study registration, no final decision has been made regarding the sharing of individual participant data (IPD). Any future data sharing will be considered in accordance with institutional policies, ethical approvals, participant consent, and applicable data protection regulations. If data sharing is approved, only de-identified data will be made available.
Publications
Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015 May 8;350:h2147. doi: 10.1136/bmj.h2147. No abstract available.
PubMed 25956159Austin PC. The performance of different propensity-score methods for estimating differences in proportions (risk differences or absolute risk reductions) in observational studies. Stat Med. 2010 Sep 10;29(20):2137-48. doi: 10.1002/sim.3854.
PubMed 20108233Baxter DE, Thigpen CM. Heel pain--operative results. Foot Ankle. 1984 Jul-Aug;5(1):16-25. doi: 10.1177/107110078400500103.
PubMed 6479759Morrissey D, Cotchett M, Said J'Bari A, Prior T, Griffiths IB, Rathleff MS, Gulle H, Vicenzino B, Barton CJ. Management of plantar heel pain: a best practice guide informed by a systematic review, expert clinical reasoning and patient values. Br J Sports Med. 2021 Oct;55(19):1106-1118. doi: 10.1136/bjsports-2019-101970. Epub 2021 Mar 30.
PubMed 33785535Roy J. Applied Longitudinal Analysis , Second Edition, by G. M. Fitzmaurice, N. M. Laird, and J. H. Ware. J Biopharm Stat 2013; 23: 491-492.
Steyerberg EW, Vergouwe Y. Towards better clinical prediction models: seven steps for development and an ABCD for validation. Eur Heart J. 2014 Aug 1;35(29):1925-31. doi: 10.1093/eurheartj/ehu207. Epub 2014 Jun 4.
PubMed 24898551Vickers AJ, Altman DG. Statistics notes: Analysing controlled trials with baseline and follow up measurements. BMJ. 2001 Nov 10;323(7321):1123-4. doi: 10.1136/bmj.323.7321.1123. No abstract available.
PubMed 11701584Carroll C, Patterson M, Wood S, Booth A, Rick J, Balain S. A conceptual framework for implementation fidelity. Implement Sci. 2007 Nov 30;2:40. doi: 10.1186/1748-5908-2-40.
PubMed 18053122Borrelli B. The assessment, monitoring, and enhancement of treatment fidelity in public health clinical trials. J Public Health Dent. 2011 Winter;71 Suppl 1:S52-63.
PubMed 21656954Al-Ashhab ME, Elbegawy HEA, Hasan HAA. Endoscopic Plantar Fasciotomy Through Two Medial Portals for the Treatment of Recalcitrant Plantar Fasciopathy. J Foot Ankle Surg. 2018 Mar-Apr;57(2):264-268. doi: 10.1053/j.jfas.2017.09.004. Epub 2017 Dec 7.
PubMed 29224949Cottom JM, Wolf JR, Sisovsky CA. Midterm Outcomes of Endoscopic Plantar Fascia Debridement in 125 Patients: A 5-Year Follow-Up. J Foot Ankle Surg. 2023 May-Jun;62(3):444-447. doi: 10.1053/j.jfas.2022.11.001. Epub 2022 Nov 10.
PubMed 36443168Chou AC, Ng SY, Koo KO. Endoscopic Plantar Fasciotomy Improves Early Postoperative Results: A Retrospective Comparison of Outcomes After Endoscopic Versus Open Plantar Fasciotomy. J Foot Ankle Surg. 2016 Jan-Feb;55(1):9-15. doi: 10.1053/j.jfas.2015.02.005. Epub 2015 May 23.
PubMed 26007627Eckenrode BJ, Kietrys DM, Parrott JS. Effectiveness of Manual Therapy for Pain and Self-reported Function in Individuals With Patellofemoral Pain: Systematic Review and Meta-analysis. J Orthop Sports Phys Ther. 2018 May;48(5):358-371. doi: 10.2519/jospt.2018.7243. Epub 2018 Jan 6.
PubMed 29308698De-la-Cruz-Torres B, Abuin-Porras V, Navarro-Flores E, Calvo-Lobo C, Romero-Morales C. Ultrasound-Guided Percutaneous Neuromodulation in Patients with Chronic Lateral Epicondylalgia: A Pilot Randomized Clinical Trial. Int J Environ Res Public Health. 2021 May 3;18(9):4877. doi: 10.3390/ijerph18094877.
PubMed 34063673Rayo-Perez AM, Juarez-Jimenez JM, Ortiz-Romero M, Gordillo-Fernandez LM, Garcia-De-La-Pena R. Comparative Effectiveness of Conservative Therapies for Plantar Fasciitis: A Retrospective Observational Study. Sports (Basel). 2025 Sep 5;13(9):306. doi: 10.3390/sports13090306.
PubMed 41003612
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Protocol for a Multicenter Controlled Trial Comparing Multimodal Conservative Intervention Versus Surgical Management in Chronic Refractory Plantar Fasciopathy
- ClinicalTrials.gov ID
- NCT07654660
- Acronym / sponsor ID
- UEV-PF-MTPNM-2026-01
- Conditions
- Chronic Refractory Plantar Fasciopathy
- Keywords
- Plantar Fasciopathy, Plantar Fasciitis, Manual Therapy, Percutaneous Neuromodulation, Endoscopic Plantar Fasciotomy, Foot Function Index, Heel Pain, Conservative Treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universidad Europea de ValenciaUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 17 Jun 2026 (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.
Chronic refractory plantar fasciopathy is a common musculoskeletal condition that can cause persistent heel pain and functional limitations despite conservative treatment. When symptoms do not improve, patients often face the decision between continuing non-surgical management or undergoing surgery. However, direct comparative evidence between these treatment strategies is limited.
This multicenter controlled trial aims to compare the effectiveness of a multimodal conservative intervention consisting of manual therapy and ultrasound-guided percutaneous neuromodulation with endoscopic plantar fascial release followed by standard postoperative rehabilitation in adults with chronic refractory plantar fasciopathy.
A total of 120 participants will be allocated to treatment groups according to their informed treatment preference within a shared decision-making process. The primary outcome will be the change in the Foot Function Index (FFI) after 6 weeks. Secondary outcomes include pain intensity, health-related quality of life, treatment adherence, adverse events, and exploratory neurophysiological measures. The results are expected to provide evidence to support clinical decision-making and optimize the management of patients with chronic refractory plantar fasciopathy.
Detailed description
Chronic refractory plantar fasciopathy is one of the most common causes of persistent heel pain and is associated with substantial disability, reduced quality of life, and limitations in daily and occupational activities. Although most patients respond to conservative management, a subgroup continues to experience symptoms despite prolonged treatment and may be considered for surgical intervention. However, evidence directly comparing optimized multimodal conservative care with surgical management remains limited.
This multicenter, non-randomized controlled trial has been designed to evaluate the comparative effectiveness of these two therapeutic strategies under real-world clinical conditions. Participants will be allocated to treatment groups according to their informed treatment preference following a standardized shared decision-making process.
The experimental group will receive a 6-week multimodal conservative intervention consisting of manual therapy techniques and ultrasound-guided percutaneous neuromodulation delivered in 12 supervised sessions. The control group will undergo endoscopic plantar fascial release followed by a standardized postoperative rehabilitation program.
The primary outcome measure is the change in the Foot Function Index (FFI) at 6 weeks after treatment initiation. Secondary outcomes include pain intensity measured using the Visual Analog Scale (VAS), health-related quality of life assessed with the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L), treatment adherence, adverse events, and exploratory neurophysiological assessment through electromyography.
To minimize the effects of treatment selection bias inherent to the non-randomized design, analyses will include adjusted analysis of covariance (ANCOVA) and inverse probability of treatment weighting (IPTW). The findings of this study are expected to provide clinically relevant evidence to support shared decision-making and optimize treatment selection for patients with chronic refractory plantar fasciopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned to one of two parallel intervention groups according to their informed treatment preference following a standardized shared decision-making process. One group will receive a multimodal conservative intervention consisting of manual therapy and ultrasound-guided percutaneous neuromodulation, while the other group will undergo endoscopic plantar fascial release followed by standardized postoperative rehabilitation.
| Arm | Type | Receives |
|---|---|---|
| Multimodal Conservative Intervention | Experimental | Procedure: Multimodal Conservative InterventionParticipants assigned to this arm will receive a 6-week multimodal conservative intervention consisting of manual therapy techniques combined with ultrasound-guided percutaneous neuromodulation, delivered in 12 supervised sessions (2 sessions per week). |
| Surgical Management | Active comparator | Procedure: Endoscopic Plantar Fascial ReleaseParticipants assigned to this arm will undergo endoscopic plantar fascial release followed by a standardized postoperative rehabilitation program, including manual therapy during the rehabilitation period. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 30 to 65 years.
- Diagnosis of chronic refractory plantar fasciopathy with symptom duration greater than 6 months.
- Failure of at least two previous conservative treatments, each lasting at least 12 weeks.
- Foot Function Index (FFI) total score ≥45 points.
- Resting pain intensity ≥4/10 on the Visual Analog Scale (VAS).
Key exclusion criteria (4 listed)
- Previous foot surgery on the affected side.
- Calcaneal stress fracture.
- Glycated hemoglobin (HbA1c) >7.5%.
- Inability or unwillingness to comply with study procedures or follow-up assessments.
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 |
|---|---|---|
| Multimodal Conservative InterventionA 6-week multimodal conservative treatment including manual therapy techniques (gastrocnemius stretching, transverse friction massage, and tibial nerve neurodynamic mobilization) combined with ultrasound-guided percutaneous neuromodulation of the posterior tibial nerve using low-frequency electrical stimulation. | Procedure or surgery | Multimodal Conservative Intervention |
| Endoscopic Plantar Fascial ReleaseEndoscopic plantar fascial release performed using a standardized surgical technique followed by a standardized postoperative rehabilitation program. | Procedure or surgery | Surgical Management |
Primary outcome
Change in Foot Function Index (FFI) total score
Time frame: Baseline and 6 weeks
The primary outcome is the change in the total Foot Function Index (FFI) score from baseline to 6 weeks after treatment initiation. The FFI is a validated patient-reported outcome measure assessing pain and functional disability related to foot disorders.
4 secondary outcomes
Change in pain intensity measured by the Visual Analog Scale (VAS)
Time frame: Baseline, 3 weeks, 6 weeks, and 12 weeks
Change in health-related quality of life assessed by the EQ-5D-5L
Time frame: Baseline, 6 weeks, and 12 weeks
Treatment adherence
Time frame: During the 6-week intervention period
Incidence of adverse events
Time frame: From baseline through 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Background: PubMed 25956159Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015 May 8;350:h2147. doi: 10.1136/bmj.h2147. No abstract available.
- Background: PubMed 20108233Austin PC. The performance of different propensity-score methods for estimating differences in proportions (risk differences or absolute risk reductions) in observational studies. Stat Med. 2010 Sep 10;29(20):2137-48. doi: 10.1002/sim.3854.
- Background: PubMed 6479759Baxter DE, Thigpen CM. Heel pain--operative results. Foot Ankle. 1984 Jul-Aug;5(1):16-25. doi: 10.1177/107110078400500103.
- Background: PubMed 33785535Morrissey D, Cotchett M, Said J'Bari A, Prior T, Griffiths IB, Rathleff MS, Gulle H, Vicenzino B, Barton CJ. Management of plantar heel pain: a best practice guide informed by a systematic review, expert clinical reasoning and patient values. Br J Sports Med. 2021 Oct;55(19):1106-1118. doi: 10.1136/bjsports-2019-101970. Epub 2021 Mar 30.
- BackgroundRoy J. Applied Longitudinal Analysis , Second Edition, by G. M. Fitzmaurice, N. M. Laird, and J. H. Ware. J Biopharm Stat 2013; 23: 491-492.
- Background: PubMed 24898551Steyerberg EW, Vergouwe Y. Towards better clinical prediction models: seven steps for development and an ABCD for validation. Eur Heart J. 2014 Aug 1;35(29):1925-31. doi: 10.1093/eurheartj/ehu207. Epub 2014 Jun 4.
- Background: PubMed 11701584Vickers AJ, Altman DG. Statistics notes: Analysing controlled trials with baseline and follow up measurements. BMJ. 2001 Nov 10;323(7321):1123-4. doi: 10.1136/bmj.323.7321.1123. No abstract available.
- Background: PubMed 18053122Carroll C, Patterson M, Wood S, Booth A, Rick J, Balain S. A conceptual framework for implementation fidelity. Implement Sci. 2007 Nov 30;2:40. doi: 10.1186/1748-5908-2-40.
- Background: PubMed 21656954Borrelli B. The assessment, monitoring, and enhancement of treatment fidelity in public health clinical trials. J Public Health Dent. 2011 Winter;71 Suppl 1:S52-63.
- Background: PubMed 29224949Al-Ashhab ME, Elbegawy HEA, Hasan HAA. Endoscopic Plantar Fasciotomy Through Two Medial Portals for the Treatment of Recalcitrant Plantar Fasciopathy. J Foot Ankle Surg. 2018 Mar-Apr;57(2):264-268. doi: 10.1053/j.jfas.2017.09.004. Epub 2017 Dec 7.
- Background: PubMed 36443168Cottom JM, Wolf JR, Sisovsky CA. Midterm Outcomes of Endoscopic Plantar Fascia Debridement in 125 Patients: A 5-Year Follow-Up. J Foot Ankle Surg. 2023 May-Jun;62(3):444-447. doi: 10.1053/j.jfas.2022.11.001. Epub 2022 Nov 10.
- Background: PubMed 26007627Chou AC, Ng SY, Koo KO. Endoscopic Plantar Fasciotomy Improves Early Postoperative Results: A Retrospective Comparison of Outcomes After Endoscopic Versus Open Plantar Fasciotomy. J Foot Ankle Surg. 2016 Jan-Feb;55(1):9-15. doi: 10.1053/j.jfas.2015.02.005. Epub 2015 May 23.
- Individual participant dataSharing planned: Undecided. At the time of study registration, no final decision has been made regarding the sharing of individual participant data (IPD). Any future data sharing will be considered in accordance with institutional policies, ethical approvals, participant consent, and applicable data protection regulations. If data sharing is approved, only de-identified data will be made available.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Conservative Intervention and Endoscopic Plantar Fascial Release in people with Chronic Refractory Plantar Fasciopathy, run by Universidad Europea de Valencia 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?
The sponsor lists 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 17 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Javier Bonastre Férez, PhD (+34644120315, javier.bonastre@universidadeuropea.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Foot Function Index (FFI) total score (time frame: Baseline and 6 weeks). 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 NCT07654660, which also lists 35 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 17 Jun 2026.