Multimodal Conservative Intervention Versus Surgery for Chronic Refractory Plantar Fasciopathy
12 de junio de 2026 actualizado por: Dr. Javier Bonastre Férez, Universidad Europea de Valencia
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
120
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Javier Bonastre Férez, PhD
- Número de teléfono: +34644120315
- Correo electrónico: javier.bonastre@universidadeuropea.es
Ubicaciones de estudio
-
-
Valencia
-
Valencia, Valencia, España, 46010
- European University of Valencia
-
Contacto:
- Javier Bonastre Férez, PhD
- Número de teléfono: +34644120315
- Correo electrónico: javier.bonastre@universidadeuropea.es
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Multimodal Conservative Intervention
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).
|
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.
|
|
Comparador activo: Surgical Management
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.
|
Endoscopic plantar fascial release performed using a standardized surgical technique followed by a standardized postoperative rehabilitation program.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Foot Function Index (FFI) total score
Periodo de tiempo: 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.
|
Baseline and 6 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in pain intensity measured by the Visual Analog Scale (VAS)
Periodo de tiempo: Baseline, 3 weeks, 6 weeks, and 12 weeks
|
Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS).
|
Baseline, 3 weeks, 6 weeks, and 12 weeks
|
|
Change in health-related quality of life assessed by the EQ-5D-5L
Periodo de tiempo: Baseline, 6 weeks, and 12 weeks
|
Health-related quality of life will be evaluated using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L).
|
Baseline, 6 weeks, and 12 weeks
|
|
Treatment adherence
Periodo de tiempo: During the 6-week intervention period
|
Treatment adherence will be assessed as the proportion of scheduled sessions attended by participants.
|
During the 6-week intervention period
|
|
Incidence of adverse events
Periodo de tiempo: From baseline through 12 weeks
|
Adverse events will be recorded and classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
|
From baseline through 12 weeks
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Tibial nerve sensory conduction velocity assessed by electromyography
Periodo de tiempo: Baseline and 12 weeks
|
Exploratory neurophysiological assessment of tibial nerve sensory conduction velocity measured by electromyography to investigate potential changes associated with the interventions.
|
Baseline and 12 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.
- Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P; CONSORT NPT Group. CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med. 2017 Jul 4;167(1):40-47. doi: 10.7326/M17-0046. Epub 2017 Jun 20.
- Vickers 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.
- DiGiovanni BF, Nawoczenski DA, Lintal ME, Moore EA, Murray JC, Wilding GE, Baumhauer JF. Tissue-specific plantar fascia-stretching exercise enhances outcomes in patients with chronic heel pain. A prospective, randomized study. J Bone Joint Surg Am. 2003 Jul;85(7):1270-7. doi: 10.2106/00004623-200307000-00013.
- 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.
- Renan-Ordine R, Alburquerque-Sendin F, de Souza DP, Cleland JA, Fernandez-de-Las-Penas C. Effectiveness of myofascial trigger point manual therapy combined with a self-stretching protocol for the management of plantar heel pain: a randomized controlled trial. J Orthop Sports Phys Ther. 2011 Feb;41(2):43-50. doi: 10.2519/jospt.2011.3504. Epub 2011 Jan 31.
- De-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.
- Yelverton C, Rama S, Zipfel B. Manual therapy interventions in the treatment of plantar fasciitis: A comparison of three approaches. Health SA. 2019 Sep 25;24:1244. doi: 10.4102/hsag.v24i0.1244. eCollection 2019.
- Riddle DL, Schappert SM. Volume of ambulatory care visits and patterns of care for patients diagnosed with plantar fasciitis: a national study of medical doctors. Foot Ankle Int. 2004 May;25(5):303-10. doi: 10.1177/107110070402500505.
- Borrelli 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.
- Rathleff MS, Molgaard CM, Fredberg U, Kaalund S, Andersen KB, Jensen TT, Aaskov S, Olesen JL. High-load strength training improves outcome in patients with plantar fasciitis: A randomized controlled trial with 12-month follow-up. Scand J Med Sci Sports. 2015 Jun;25(3):e292-300. doi: 10.1111/sms.12313. Epub 2014 Aug 21.
- Goff JD, Crawford R. Diagnosis and treatment of plantar fasciitis. Am Fam Physician. 2011 Sep 15;84(6):676-82.
- Carroll 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.
- Schwartz EN, Su J. Plantar fasciitis: a concise review. Perm J. 2014 Winter;18(1):e105-7. doi: 10.7812/TPP/13-113.
- England JD, Gronseth GS, Franklin G, Carter GT, Kinsella LJ, Cohen JA, Asbury AK, Szigeti K, Lupski JR, Latov N, Lewis RA, Low PA, Fisher MA, Herrmann DN, Howard JF Jr, Lauria G, Miller RG, Polydefkis M, Sumner AJ; American Academy of Neurology. Practice Parameter: evaluation of distal symmetric polyneuropathy: role of laboratory and genetic testing (an evidence-based review). Report of the American Academy of Neurology, American Association of Neuromuscular and Electrodiagnostic Medicine, and American Academy of Physical Medicine and Rehabilitation. Neurology. 2009 Jan 13;72(2):185-92. doi: 10.1212/01.wnl.0000336370.51010.a1. Epub 2008 Dec 3.
- Budiman-Mak E, Conrad KJ, Roach KE. The Foot Function Index: a measure of foot pain and disability. J Clin Epidemiol. 1991;44(6):561-70. doi: 10.1016/0895-4356(91)90220-4.
- Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krle A-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Rev Panam Salud Publica. 2015 Dec;38(6):506-14.
- Monteagudo M, de Albornoz PM, Gutierrez B, Tabuenca J, Alvarez I. Plantar fasciopathy: A current concepts review. EFORT Open Rev. 2018 Aug 29;3(8):485-493. doi: 10.1302/2058-5241.3.170080. eCollection 2018 Aug.
- Rhim HC, Kwon J, Park J, Borg-Stein J, Tenforde AS. A Systematic Review of Systematic Reviews on the Epidemiology, Evaluation, and Treatment of Plantar Fasciitis. Life (Basel). 2021 Nov 24;11(12):1287. doi: 10.3390/life11121287.
- Chou 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.
- Baxter DE, Thigpen CM. Heel pain--operative results. Foot Ankle. 1984 Jul-Aug;5(1):16-25. doi: 10.1177/107110078400500103.
- Austin 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.
- Morrissey 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.
- Roy 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.
- Al-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.
- Cottom 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.
- Eckenrode 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.
- Rayo-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.
- Razzano C, Carbone S, Mangone M, Iannotta MR, Battaglia A, Santilli V. Treatment of Chronic Plantar Fasciitis with Noninvasive Interactive Neurostimulation: A Prospective Randomized Controlled Study. J Foot Ankle Surg. 2017 Jul-Aug;56(4):768-772. doi: 10.1053/j.jfas.2017.02.015.
- Zhong M, Yu B, Wang R, Qu B, Liu W, Shi S. Ultrasound-Guided Zhengqing Fengtongning vs Corticosteroid Injections for Plantar Fasciitis: A Randomized Controlled Trial on Short- and Long-Term Efficacy. Med Sci Monit. 2026 Feb 1;32:e950455. doi: 10.12659/MSM.950455.
- Eshraghi Y, Chakravarthy K, Strand NH, Shirvalkar P, Schuster NM, Abdallah RT, Vallejo R, Sayed D, Kim D, Kim C, Meacham K, Deer T; Translational Research Committee American Society of Pain and Neuroscience (ASPN). The American Society of Pain and Neuroscience (ASPN) Practical Guidelines to Study Design and Scientific Manuscript Preparation in Neuromodulation. J Pain Res. 2021 Apr 16;14:1027-1041. doi: 10.2147/JPR.S295502. eCollection 2021.
- U.S. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Bethesda, MD, 2017.
- Chou TA, Tzeng YH, Teng MH, Huang YC, Wang CS, Lin CC, Chiang CC. Trimalleolar Fractures Treated by Open Reduction Internal Fixation Compared With Arthroscopically Assisted Reduction and Minimally Invasive Surgery. Foot Ankle Int. 2023 May;44(5):431-442. doi: 10.1177/10711007231157676. Epub 2023 Mar 22.
- Nery C, Coughlin MJ, Baumfeld D, Mann TS. Lesser metatarsophalangeal joint instability: prospective evaluation and repair of plantar plate and capsular insufficiency. Foot Ankle Int. 2012 Apr;33(4):301-11. doi: 10.3113/FAI.2012.0301.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de diciembre de 2026
Finalización primaria (Estimado)
1 de septiembre de 2027
Finalización del estudio (Estimado)
1 de enero de 2028
Fechas de registro del estudio
Enviado por primera vez
12 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
12 de junio de 2026
Publicado por primera vez (Actual)
17 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UEV-PF-MTPNM-2026-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .