Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:36 AM
Study NCT ID:
NCT07471035
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Focused Shockwave Therapy for Plantar Fasciopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D036981', 'term': 'Fasciitis, Plantar'}, {'id': 'D005208', 'term': 'Fasciitis'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005534', 'term': 'Foot Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcomes Assessor is blinded to the group allocation. This assessor performs all ultrasonographic measurements and clinical data analysis to prevent observation bias and ensure the objective evaluation of plantar fascia structural changes'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a prospective, randomized, wait-list controlled pilot study utilizing a parallel assignment model. Participants are randomized into two groups to compare the clinical and structural effects of focused Extracorporeal Shockwave Therapy (fESWT) against a control group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-10', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': 'baseline,4,8 and 12 weeks', 'description': 'Pain intensity will be measured using a 100-cm Visual Analogue Scale, where 0 represents "no pain" and 10 represents "the worst pain imaginable." A higher score indicates greater pain intensity.'}, {'measure': 'Plantar Fascia (PF) Thickness', 'timeFrame': 'Baseline, 4 weeks, 8 weeks, and 12 weeks.', 'description': 'The thickness of the plantar fascia will be measured in millimeters (mm) using high-resolution B-mode ultrasound. Measurements are taken approximately 1 cm distal to the calcaneal insertion. A decrease in thickness is associated with tissue remodeling and clinical recovery.'}], 'secondaryOutcomes': [{'measure': 'Foot Function Index (FFI) Score', 'timeFrame': 'Baseline, 4 weeks, 8 weeks, and 12 weeks.', 'description': 'The Foot Function Index (FFI) is a self-administered questionnaire used to measure foot pain and disability. The score is expressed as a percentage (0-100%), where higher percentages indicate greater disability and worse foot health.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FOCUSED SHOCK WAVE THERAPY', 'fESWT', 'PLANTAR FASCIA THICKNESS'], 'conditions': ['Plantar Fascitis', 'Chronic Plantar Fasciitis', 'Fasciitis']}, 'descriptionModule': {'briefSummary': 'This study investigates whether focused Extracorporeal Shockwave Therapy (fESWT) helps people with chronic heel pain, commonly known as plantar fasciitis. Many patients suffer from this condition for more than six months without relief.\n\nThe study compares two groups: one receiving fESWT treatment plus a specific exercise program, and a "wait-list" group that only performs the exercises at first. The shockwave treatment uses precise sound waves targeted at the painful area to stimulate the body\'s natural healing process.\n\nResearchers will measure if the treatment reduces pain and improves the patient\'s ability to walk and perform daily activities. Additionally, ultrasound will be used to see if the thickness of the plantar fascia (the tissue under the foot) decreases and returns to a healthier state. The goal is to confirm if fESWT provides a faster and more effective recovery than exercise alone.', 'detailedDescription': 'This is a prospective, randomized, wait-list controlled pilot study designed to evaluate the clinical and structural effects of focused Extracorporeal Shockwave Therapy (fESWT) on chronic plantar fasciopathy.Study Design and Participants:Twenty participants with chronic plantar heel pain lasting more than six months were enrolled. Inclusion criteria required a diagnosis of plantar fasciopathy confirmed by a thickness of \\> 4.0 mm on ultrasound. Participants were randomized 1:1 into an Experimental Group (fESWT + High-Load Strength Training) or a Wait-list Control Group (High-Load Strength Training only).Intervention Protocol:fESWT Administration: The experimental group received three sessions of fESWT once per week. Each session consisted of 2,000 pulses at a frequency of 5-8 Hz.Energy Settings: The Energy Flux Density (EFD) was titrated based on patient tolerance, ranging from 0.10 to 0.30 mJ/mm\\^2, using a "point-and-shoot" technique at the site of maximal tenderness.Standard of Care: All participants followed a progressive High-Load Strength Training (HLST) protocol, performing heel raises every other day.Assessments and Follow-up:The primary outcome measures include pain intensity via the Visual Analogue Scale (VAS) and functional disability via the Foot Function Index (FFI). Secondary outcomes focus on structural remodeling of the plantar fascia measured by high-resolution ultrasound. Evaluations are conducted at baseline and at 4, 8, and 12 weeks post-intervention to track both immediate rescue effects and long-term tissue normalization.Wait-list Management:To maintain ethical standards, the wait-list control group received the fESWT intervention after the initial 4-week comparative period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged between 18 and 70 years. Diagnosis of chronic plantar fasciopathy with symptoms persisting for more than 6 months.\n\nPresence of plantar fascia (PF) thickness \\> 4.0 mm, confirmed by high-resolution ultrasound.\n\nClinical history of localized pain at the medial calcaneal tubercle, specifically upon first steps in the morning or after prolonged rest.\n\nFailure of previous conservative treatments (e.g., stretching, orthotics, or medication).\n\nAbility to follow the High-Load Strength Training (HLST) exercise protocol.\n\nExclusion Criteria:\n\n* Previous treatment with shockwave therapy or corticosteroid injections in the affected foot within the last 6 months.\n\nPrevious surgery for plantar heel pain.\n\nPresence of systemic inflammatory diseases (e.g., rheumatoid arthritis, ankylosing spondylitis).\n\nPregnancy.\n\nCoagulopathies or use of anticoagulant medication.\n\nLocal infection or presence of skin lesions at the application site.\n\nKnown or suspected malignancy in the treatment area.\n\nPresence of neurological conditions or peripheral neuropathy (e.g., tarsal tunnel syndrome).'}, 'identificationModule': {'nctId': 'NCT07471035', 'briefTitle': 'Focused Shockwave Therapy for Plantar Fasciopathy', 'organization': {'class': 'OTHER', 'fullName': 'Sierra Varona SL'}, 'officialTitle': 'Focused ESWT vs. Wait-list Management for Plantar Fasciopathy: A Randomized Controlled Trial Evaluating Pain, Function, and Ultrasonographic Plantar Fascia Thickness', 'orgStudyIdInfo': {'id': '23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'fESWT', 'description': 'Participants in this arm receive three weekly sessions of focused Extracorporeal Shockwave Therapy (fESWT). The treatment consists of 2,000 pulses per session with an Energy Flux Density (EFD) titrated to patient tolerance (ranging from 0.10 to 0.30 mJ/mm2) at a frequency of 5-8 Hz.', 'interventionNames': ['Device: fESWT', 'Other: Wait-list Control: Exercise Only']}, {'type': 'OTHER', 'label': 'Wait-list Control: Exercise Only', 'description': 'Participants in this wait-list control arm perform only the standardized High-Load Strength Training (HLST) program (progressive heel-rises every other day) during the initial 4-week comparative phase. This arm serves as the control group to evaluate the specific clinical and structural added value of fESWT. For ethical reasons, after the primary 4-week assessment is completed, these participants are offered the same fESWT protocol administered to the experimental group.', 'interventionNames': ['Other: Wait-list Control: Exercise Only']}], 'interventions': [{'name': 'fESWT', 'type': 'DEVICE', 'description': 'Three weekly sessions of focused shockwave therapy. Each session consists of 2,000 pulses at a frequency of 5-8 Hz. The Energy Flux Density (EFD) is titrated between 0.10 and 0.30 mJ/mm2 based on patient tolerance. The "point-and-shoot" technique is applied to the site of maximal tenderness.', 'armGroupLabels': ['fESWT']}, {'name': 'Wait-list Control: Exercise Only', 'type': 'OTHER', 'description': 'Participants assigned to this arm will undergo a wait-list period of 4 weeks during which they only perform the standardized High-Load Strength Training (HLST) program. The HLST consists of progressive unilateral heel-rise exercises performed every other day. This group serves as a comparative control to assess the clinical and structural changes (plantar fascia thickness) without the addition of shockwave therapy during the initial phase. After the primary 4-week assessment is completed, participants in this arm are offered the same focused Extracorporeal Shockwave Therapy (fESWT) protocol as the experimental group for ethical reasons.', 'armGroupLabels': ['Wait-list Control: Exercise Only', 'fESWT']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sierra Varona SL', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad Europea de Madrid', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}