Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT06145620
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-12
First Post:
2023-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of a Prehabilitation Program in Patients Undergoing Lumbar Radiculopathy Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011843', 'term': 'Radiculopathy'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2023-11-17', 'studyFirstSubmitQcDate': '2023-11-17', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': '4 weeks', 'description': 'Disability score (0-100). Higher score indicates higher disability.'}], 'secondaryOutcomes': [{'measure': 'SF-McGill Pain Questionnaire (SF-MGPQ)', 'timeFrame': '4 weeks', 'description': 'Pain score (0-45). Higher score indicates higher pain level'}, {'measure': 'Numerical Rating Scale (NRS)', 'timeFrame': '4 weeks', 'description': 'Pain score 0-10. Higher score indicates higher pain intensity.'}, {'measure': 'EuroQol-5D (EQ-5D)', 'timeFrame': '4 weeks', 'description': 'Quality of life score (-0.5 to 1).Higher score indicates higher health-related quality of life'}, {'measure': 'Fear avoidance beliefs questionnaire (FABQ)', 'timeFrame': '4 weeks', 'description': 'FABQ-Work subscale (ranging from 0 to 42) and FABQ-Physical Activity subscale (ranging from 0 to 24). Higher score indicates more signs of fear avoidance'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '4 weeks', 'description': 'Anxiety and depression score (0-21). Hhigher score indicates greater symptoms of anxiety and depression.'}, {'measure': 'Pain catastrophizing scale (PCS)', 'timeFrame': '4 weeks', 'description': 'pain catastrophizing score (0-52). Higher scores indicate greater pain catastrophizing'}, {'measure': 'Tampa scale for kinesiophobia (TSK-11SV)', 'timeFrame': '4 weeks', 'description': 'kinesiophobia score (11-44). Higher scores indicate greater kinesiophobia'}, {'measure': 'International Physical Activity Questionnaire (IPAQ)', 'timeFrame': '4 weeks', 'description': 'Physical activity level (MET minutes a week). Higher scores indicate higher physical activity level'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lumbar Radiculopathy']}, 'referencesModule': {'references': [{'pmid': '29253630', 'type': 'BACKGROUND', 'citation': 'Lindback Y, Tropp H, Enthoven P, Abbott A, Oberg B. PREPARE: presurgery physiotherapy for patients with degenerative lumbar spine disorder: a randomized controlled trial. Spine J. 2018 Aug;18(8):1347-1355. doi: 10.1016/j.spinee.2017.12.009. Epub 2017 Dec 15.'}, {'pmid': '23478459', 'type': 'BACKGROUND', 'citation': 'Louw A, Butler DS, Diener I, Puentedura EJ. Development of a preoperative neuroscience educational program for patients with lumbar radiculopathy. Am J Phys Med Rehabil. 2013 May;92(5):446-52. doi: 10.1097/PHM.0b013e3182876aa4.'}, {'pmid': '30921465', 'type': 'BACKGROUND', 'citation': 'Goudman L, Huysmans E, Ickmans K, Nijs J, Moens M, Putman K, Buyl R, Louw A, Logghe T, Coppieters I. A Modern Pain Neuroscience Approach in Patients Undergoing Surgery for Lumbar Radiculopathy: A Clinical Perspective. Phys Ther. 2019 Jul 1;99(7):933-945. doi: 10.1093/ptj/pzz053.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the following study is to analyze the effects of a prehabilitation program based on therapeutic exercise, back care education and pain neuroscience education through the visualization of videos, compared to standardized written therapeutic exercise in patients undergoing lumbar radiculopathy surgery.', 'detailedDescription': 'So far, there are no previous studies that analyze the effects of a prehabilitation program including therapeutic exercise, back care education and pain neuroscience education through the visualization of videos in patients undergoing lumbar radiculopathy surgery.\n\nThis is a multicenter randomized clinical trial aimed at analyzing the effects of a 4 weeks prehabilitation program based on video visualization versus the performance of standardized written exercises in patients undergoing lumbar radiculopathy surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years or older, diagnosed with lumbar radiculopathy, and scheduled for surgery. The symptoms will be predominantly leg pain with or without neurological deficit, with surgical decompression justified.\n\nExclusion Criteria:\n\n* Patients currently receiving any other non-pharmacological treatment or physical therapy for the management of lumbar radiculopathy.\n* Proposed for surgery with instrumentation (e.g., spinal fusion, arthrodesis).\n* Suffering from a chronic pain-related condition (e.g., fibromyalgia, chronic fatigue syndrome).\n* Symptoms of spinal cord compression.\n* Diagnosed with a malignant tumor.\n* Mental illness.\n* Previously undergone spinal surgery.\n* No access to any internet-enabled device.'}, 'identificationModule': {'nctId': 'NCT06145620', 'briefTitle': 'Effects of a Prehabilitation Program in Patients Undergoing Lumbar Radiculopathy Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cardenal Herrera University'}, 'officialTitle': 'Effects of a Prehabilitation Program Based on Therapeutic Exercise, Back Care Education and Neuroscience Pain Education in Patients Undergoing Lumbar Radiculopathy Surgery', 'orgStudyIdInfo': {'id': 'CEEI23/459'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Therapeutic exercise, back care and pain neuroscience education group', 'interventionNames': ['Other: Physiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standarized written exercise group', 'interventionNames': ['Other: Physiotherapy']}], 'interventions': [{'name': 'Physiotherapy', 'type': 'OTHER', 'description': 'The intervention involves the visualization of different videos explaining the performance of lumbar strengthening exercises, measures for back care, and neuroscience pain education.', 'armGroupLabels': ['Standarized written exercise group', 'Therapeutic exercise, back care and pain neuroscience education group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Valencia', 'country': 'Spain', 'facility': 'Arguisuelas Martinez Maria Dolores', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'centralContacts': [{'name': 'María Dolores Arguisuelas', 'role': 'CONTACT', 'email': 'doloresarguisuelas@uchceu.es', 'phone': '96 136 90 00'}, {'name': 'María Dolores Arguisuelas', 'role': 'CONTACT', 'email': 'doloresarguisuelas@uchceu.es'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardenal Herrera University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'ARGUISUELAS MARTINEZ MARÍA DOLORES', 'investigatorAffiliation': 'Cardenal Herrera University'}}}}