Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-01-11 @ 7:03 AM
Study NCT ID:
NCT07233395
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effectiveness of Dextrose Prolotherapy and Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D036981', 'term': 'Fasciitis, Plantar'}], 'ancestors': [{'id': 'D005208', 'term': 'Fasciitis'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005534', 'term': 'Foot Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000075527', 'term': 'Prolotherapy'}, {'id': 'D000074059', 'term': 'Extracorporeal Shockwave Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014464', 'term': 'Ultrasonic Therapy'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcome assessor will be blinded to treatment allocation. Participants and care providers will be aware of the intervention due to the nature of the treatments.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to one of two parallel groups. One group will receive dextrose prolotherapy and the other will receive extracorporeal shock wave therapy (ESWT).\n\nThe study aims to compare the effectiveness of these two regenerative treatment methods in patients with plantar fasciitis.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Heel Pain Intensity (VAS Score)', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'Heel pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS) at baseline, 6 weeks, and 12 weeks. The primary outcome is the change in VAS score from baseline to week 12 in each treatment group.'}], 'secondaryOutcomes': [{'measure': 'Change in Foot Function Index (FFI) Total Score', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'Functional status will be assessed using the Foot Function Index (FFI), which evaluates pain, disability, and activity limitation related to foot function. The total FFI score will be recorded at baseline, 6 weeks, and 12 weeks. The secondary outcome is the change in FFI total score over time.'}, {'measure': 'Change in Roles and Maudsley Score', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'The Roles and Maudsley functional pain score will be used to evaluate treatment response. Patients grade their condition on a 4-point scale from "excellent" to "poor." Scores will be obtained at baseline, 6 weeks, and 12 weeks. Improvement in score indicates better clinical outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dextrose Prolotherapy', 'Extracorporeal Shock Wave Therapy (ESWT)', 'Physical Medicine and Rehabilitation'], 'conditions': ['Plantar Fasciitis']}, 'descriptionModule': {'briefSummary': 'Plantar fasciitis is a degeneration of the plantar aponeurosis and is the most common cause of heel pain (11-15%). Although seen in both sexes, plantar fasciitis is more common in women, usually unilateral and bilateral in 30% of cases . The most widely accepted view regarding the formation of plantar fasciitis is that it is a degenerative process caused by myxoid degeneration, microtears, collagen necrosis, and angiofibroblastic hyperplasia, resulting from repetitive microtrauma to the plantar fascia, particularly at the calcaneal insertion site. It is not inflammatory . The purpose of this study was to compare the effectiveness of prolotherapy, a regenerative treatment, and ESWT in the treatment of plantar fasciitis.', 'detailedDescription': 'Plantar fasciitis is known as the most common cause of heel pain in adults. While its incidence increases between the ages of 40 and 60, it is more common in runners, those who work in positions requiring prolonged standing, overweight individuals, and those with certain biomechanical foot problems. Diagnosis of plantar fasciitis can be easily made through history and physical examination. Conservative methods are the first line of treatment. Local injections and ESWT are used in patients who fail to improve despite conservative treatment. ESWT and Prolotherapy are treatment methods that induce regeneration by creating a controlled inflammation. This prospective study aims to compare the effectiveness of ESWT and Prolotherapy, which have similar mechanisms of action, in the treatment of plantar fasciitis and to identify the more effective method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of plantar fasciitis\n\nAges 18 to 75 years\n\nBoth male and female participants\n\nHeel pain localized to the medial calcaneal tubercle for more than 3 months\n\nMorning first-step pain and pain increasing with daily loading\n\nWillingness to participate and provide written informed consent\n\nPatients presenting to Kanuni Sultan Süleyman Training and Research Hospital\n\nExclusion Criteria:\n\nCardiac pacemaker\n\nType 1 or Type 2 diabetes mellitus\n\nHistory of inflammatory rheumatic disease\n\nBleeding disorders\n\nUse of anticoagulant medications other than aspirin\n\nAllergy to dextrose\n\nPrevious foot or ankle surgery\n\nPeripheral neuropathy\n\nS1 radiculopathy in the same extremity\n\nLocal corticosteroid injection to the plantar fascia within the last 3 months\n\nESWT applied to the plantar fascia within the last 3 months\n\nPhysical therapy applied to the foot/ankle in the last 3 months\n\nCognitive dysfunction\n\nActive infection at the planned injection site\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07233395', 'briefTitle': 'Comparison of the Effectiveness of Dextrose Prolotherapy and Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Comparison of the Effectiveness of Dextrose Prolotherapy and Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis', 'orgStudyIdInfo': {'id': 'KanuniSSTRH-PF-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dextrose Prolotherapy', 'description': 'Participants in this group will receive dextrose prolotherapy twice, at two-week intervals.\n\nA 5 mL syringe will be prepared with 2.5 mL of 30% dextrose, 2 mL of isotonic saline, and 0.5 mL of 2% lidocaine (final 15% dextrose solution).\n\nInjections will be administered into seven points around the plantar fascia origin and insertion under aseptic conditions.', 'interventionNames': ['Procedure: Dextrose Prolotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Extracorporeal Shock Wave Therapy (ESWT)', 'description': 'Participants in this group will receive extracorporeal shock wave therapy (ESWT) twice per week for a total of four sessions.\n\nThe treatment will be applied to the plantar fascia insertion using a standard clinical ESWT device following manufacturer guidelines.', 'interventionNames': ['Device: Extracorporeal Shock Wave Therapy (ESWT)']}], 'interventions': [{'name': 'Dextrose Prolotherapy', 'type': 'PROCEDURE', 'otherNames': ['Prolotherapy Injection'], 'description': 'Participants in this group will receive dextrose prolotherapy twice, at two-week intervals.\n\nA 5 mL syringe containing 2.5 mL of 30% dextrose, 2 mL isotonic saline, and 0.5 mL 2% lidocaine (final 15% dextrose solution) will be injected into seven points around the plantar fascia origin under aseptic conditions.', 'armGroupLabels': ['Dextrose Prolotherapy']}, {'name': 'Extracorporeal Shock Wave Therapy (ESWT)', 'type': 'DEVICE', 'otherNames': ['Shock Wave Therapy'], 'description': 'Participants in this group will receive extracorporeal shock wave therapy (ESWT) twice per week for a total of four sessions.\n\nThe treatment will be applied to the plantar fascia insertion area using a standard clinical shock wave therapy device.\n\nEnergy level, frequency, and pulse count will be set according to manufacturer recommendations and standard clinical protocols.', 'armGroupLabels': ['Extracorporeal Shock Wave Therapy (ESWT)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ZEYNEP KARAKUZU GÜNGÖR', 'role': 'CONTACT', 'email': 'zeynepkarakuzu@hotmail.com.tr', 'phone': '+905077750375'}], 'overallOfficials': [{'name': 'ZEYNEP KARAKUZU GÜNGÖR, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kanuni Sultan Süleyman Training and Research Hospital, Istanbul'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared. Data will only be accessible to the research team in accordance with institutional ethical guidelines and patient confidentiality regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physical Medicine and Rehabilitation', 'investigatorFullName': 'Zeynep Karakuzu Güngör', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}