Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-01-10 @ 7:21 PM
Study NCT ID:
NCT06480851
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Percutaneous Neuromodulation in the Treatment of Cervical Pain in University Students.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-25', 'studyFirstSubmitDate': '2024-02-03', 'studyFirstSubmitQcDate': '2024-06-25', 'lastUpdatePostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain threshold', 'timeFrame': 'up to 1 Week', 'description': 'Portable hand pressure algometer (FPX 50/220, Wagner Instruments, Greenwich, USA), measured in kg / cm² (kilogram per centimeter squared).'}], 'secondaryOutcomes': [{'measure': 'Pain by visual analog scale', 'timeFrame': 'Baseline', 'description': 'usual visual analog scale (VAS) of pain (line from 0: no pain to 10:worst pain)'}, {'measure': 'Pain by visual analog scale', 'timeFrame': 'after intervention', 'description': 'usual visual analog scale (VAS) of pain (line from 0: no pain to 10:worst pain)'}, {'measure': 'Pain by visual analog scale', 'timeFrame': 'Follow-up at 1 week', 'description': 'usual visual analog scale (VAS) of pain (line from 0: no pain to 10:worst pain)'}, {'measure': 'Neck Disability Index Questionnaire.', 'timeFrame': 'Baseline', 'description': 'Quantification of pain and disabilty'}, {'measure': 'Neck Disability Index Questionnaire.', 'timeFrame': 'after intervention', 'description': 'Quantification of pain and disabilty'}, {'measure': 'Neck Disability Index Questionnaire.', 'timeFrame': 'Follow-up at 1 week', 'description': 'Quantification of pain and disabilty'}, {'measure': 'Kinesiophobia', 'timeFrame': 'Baseline', 'description': 'Measured with Tampa Kinesiophobia Scale questionnaire (TSK-11SV) Spanish version. Minimum and maximum values are between 11 and 44 point, a result with higher values indicates higher level of kinesiofobia.'}, {'measure': 'Kinesiophobia', 'timeFrame': 'after intervention', 'description': 'Measured with Tampa Kinesiophobia Scale questionnaire (TSK-11SV) Spanish version. Minimum and maximum values are between 11 and 44 point, a result with higher values indicates higher level of kinesiofobia.'}, {'measure': 'Kinesiophobia', 'timeFrame': 'Follow-up at 1 week', 'description': 'Measured with Tampa Kinesiophobia Scale questionnaire (TSK-11SV) Spanish version. Minimum and maximum values are between 11 and 44 point, a result with higher values indicates higher level of kinesiofobia.'}, {'measure': 'Pain Catastrophizing Scale', 'timeFrame': 'Baseline', 'description': "Pain Catastrophizing Scale (PAS) will be used to evaluate the participants' pain-related thoughts and feelings."}, {'measure': 'Pain Catastrophizing Scale', 'timeFrame': 'after intervention', 'description': "Pain Catastrophizing Scale (PAS) will be used to evaluate the participants' pain-related thoughts and feelings."}, {'measure': 'Pain Catastrophizing Scale', 'timeFrame': 'Follow-up at 1 week', 'description': "Pain Catastrophizing Scale (PAS) will be used to evaluate the participants' pain-related thoughts and feelings."}, {'measure': 'Health-related quality of life', 'timeFrame': 'Baseline', 'description': 'The Short Form Health Questionnaire (SF-36) questionnaire, which examines health-related quality of life under eight sub-titles; It consists of 36 items. The SF36 questionnaire will be used in the study.'}, {'measure': 'Health-related quality of life', 'timeFrame': 'after intervention', 'description': 'The Short Form Health Questionnaire (SF-36) questionnaire, which examines health-related quality of life under eight sub-titles; It consists of 36 items. The SF36 questionnaire will be used in the study.'}, {'measure': 'Health-related quality of life', 'timeFrame': 'Follow-up at 1 week', 'description': 'The Short Form Health Questionnaire (SF-36) questionnaire, which examines health-related quality of life under eight sub-titles; It consists of 36 items. The SF36 questionnaire will be used in the study.'}, {'measure': 'Sonoelastography', 'timeFrame': 'Baseline', 'description': 'This diagnostic test would be executed by a Physiotherapist who has experiences of using General Electric, P9 model ultrasound system for more than three year. The equipment to obtain the image will be used with a frequency of 12 MHz, 22 dB gain, 85 dynamic range, brightness at 17 and depth of 4 cm.\n\nThe transducer will be placed on the spinosa of C4 and the probe will be moved towards the transverse of each of the sides, to identify the image of the multifidus muscle in depth.\n\nOnce the muscle is located in this segment, a longitudinal and transverse image of the muscle will be obtained, performing the elastography at the same time and calculating the elastographic values (tissue resistance in kilopascals and transmission speed in meters/second).'}, {'measure': 'Sonoelastography', 'timeFrame': 'after intervention', 'description': 'This diagnostic test would be executed by a Physiotherapist who has experiences of using General Electric, P9 model ultrasound system for more than three year. The equipment to obtain the image will be used with a frequency of 12 MHz, 22 dB gain, 85 dynamic range, brightness at 17 and depth of 4 cm.\n\nThe transducer will be placed on the spinosa of C4 and the probe will be moved towards the transverse of each of the sides, to identify the image of the multifidus muscle in depth.\n\nOnce the muscle is located in this segment, a longitudinal and transverse image of the muscle will be obtained, performing the elastography at the same time and calculating the elastographic values (tissue resistance in kilopascals and transmission speed in meters/second).'}, {'measure': 'Sonoelastography', 'timeFrame': 'Follow-up at 1 week', 'description': 'This diagnostic test would be executed by a Physiotherapist who has experiences of using General Electric, P9 model ultrasound system for more than three year. The equipment to obtain the image will be used with a frequency of 12 MHz, 22 dB gain, 85 dynamic range, brightness at 17 and depth of 4 cm.\n\nThe transducer will be placed on the spinosa of C4 and the probe will be moved towards the transverse of each of the sides, to identify the image of the multifidus muscle in depth.\n\nOnce the muscle is located in this segment, a longitudinal and transverse image of the muscle will be obtained, performing the elastography at the same time and calculating the elastographic values (tissue resistance in kilopascals and transmission speed in meters/second).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain', 'Ecoguided Percutaneous Neuromodulation'], 'conditions': ['Neck Pain']}, 'descriptionModule': {'briefSummary': 'A non-randomized experimental study will be conducted to investigate the effect of Ecoguided Percutaneous Neuromodulation on patients with and without neck pain in college students. The sample will be collected in a non-probabilistic way at convenience among the students at the San Pablo-CEU University, with a sample that will be divided into two groups: group 1 (G1) with neck pain and group 2 (G2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current Cervical Pain on a Visual Analog Scale (VAS) greater than 3.\n* Neck pain in the last 12 weeks, and no treatment has been performed.\n* Disability index of 8% or more on the Neck Disability Index.\n* That they have undergone treatment.\n\nExclusion Criteria:\n\n* Neck pain associated with vertigo.\n* Osteoporosis (control X-ray).\n* Diagnosed psychological disorders.\n* Vertebral fractures (control X-ray).\n* Tumors.\n* Diagnosed metabolic diseases.\n* Neck surgery.\n* Belonephobia.'}, 'identificationModule': {'nctId': 'NCT06480851', 'briefTitle': 'Effectiveness of Percutaneous Neuromodulation in the Treatment of Cervical Pain in University Students.', 'organization': {'class': 'OTHER', 'fullName': 'CEU San Pablo University'}, 'officialTitle': 'Effectiveness of Percutaneous Neuromodulation in the Treatment of Cervical Pain in University Students.', 'orgStudyIdInfo': {'id': 'CEU-026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neck Pain Group', 'interventionNames': ['Procedure: Ecoguided Percutaneous Neuromodulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non Neck Pain Group', 'interventionNames': ['Procedure: Ecoguided Percutaneous Neuromodulation']}], 'interventions': [{'name': 'Ecoguided Percutaneous Neuromodulation', 'type': 'PROCEDURE', 'description': 'Ecoguided Percutaneous Neuromodulation over the posterior branch of the cervical multifidus, for 10 minutes, with a frequency of 10 HZ.', 'armGroupLabels': ['Neck Pain Group', 'Non Neck Pain Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28668', 'city': 'Boadilla del Monte', 'state': 'Madrid', 'country': 'Spain', 'contacts': [{'name': 'Francisco García-Muro San José, MSc, PT', 'role': 'CONTACT', 'email': 'fgarciamuro@ceu.es', 'phone': '91 3724700', 'phoneExt': '14689'}, {'name': 'Elena Sánchez Jiménez, MSc, PT', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Francisco García-Muro San José, MSc, PT', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sonia Gómez Sánchez,, MSc, PT', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'San Pablo CEU University', 'geoPoint': {'lat': 40.405, 'lon': -3.87835}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CEU San Pablo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad Católica de Ávila', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}