Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-02-28 @ 4:57 AM
Study NCT ID:
NCT05265468
Status:
COMPLETED
Last Update Posted:
2022-05-20
First Post:
2022-01-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Noninvasive Treatment of Upper Trapezius Active Trigger Points in College Students With Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-19', 'studyFirstSubmitDate': '2022-01-20', 'studyFirstSubmitQcDate': '2022-02-22', 'lastUpdatePostDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neck Disability Index', 'timeFrame': '10 minutes', 'description': 'Self-completed neck questionnaire wich consists in 10 sections. Each one of them (cervical pain intensity, personal care, lifting weights, reading, headache, ability to concentrate, ability to work, driving, sleep and leisure activities) offers 6 possible answers that represent 6 progressive levels of functional capacity, and is scored from 0 to 5. The total score is expressed in percentage terms with respect to the maximum possible'}, {'measure': 'Pain intensity', 'timeFrame': '10 minutes', 'description': 'Measured with Numeric Rating Scale wich consist in measure pain intensity with a score of 0-10'}, {'measure': 'Pression algometer', 'timeFrame': '10 minutes', 'description': 'Measures pressure pain thresholds'}], 'secondaryOutcomes': [{'measure': 'Cervical Test', 'timeFrame': '10 minutes', 'description': 'Measured with Baiobit Software. The range of movement will be measured in grades as per: flexion/extension; right/left rotation; and right/left inclination'}, {'measure': 'Proprioceptive Test', 'timeFrame': '10 minutes', 'description': "Measured with Baiobit Software o'clock test in a high/medium/low levels wich consist in a velocity and accuracy evaluation of combined cervical movements in the o'clock game test."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physiotherapy', 'Rehabilitation', 'Treatment', 'Active Trigger Point'], 'conditions': ['Neck Pain', 'Trigger Point Pain, Myofascial']}, 'descriptionModule': {'briefSummary': 'Hyperexcitable myofascial trigger points located within a taut band of skeletal muscle or fascia cause referred pain, local tenderness, and autonomic changes. The scientific data refer to an immediate improvement in the symptoms of these active points treated with manual therapy. Based on these factors, the objective of the study is to determine the effect of the combined therapy of the Jones, Chaitow, Lewit technique and pain-free positioning in participants with the presence of an active upper trapezius trigger point.', 'detailedDescription': 'The treatment will last a total of 15 minutes accompanied by a baseline assessment and after 10 minutes of the intervention in 3 experimental groups and a placebo group, of no-pain positioning. In addition to basic indices and scales of cervical pain and functionality, it is intended to measure flexibility, range of motion, proprioception and cognition through software with sensors of the latest technology when it comes to representing reliable results in differences between techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* persistent neck pain or headache for more than 3 days\n* presence of active trigger point in upper trapezius\n\nExclusion Criteria:\n\n* Participants who present dizziness, vertigo and/or symptoms aggravated by the movement and/or positioning of the neck;\n* who present infection or febrile state at the time of performing the test;\n* with anxiety and/or extreme emotional tension;\n* who are undergoing pharmacological treatment (analgesics, muscle relaxants, anxiolytics, antidepressants)'}, 'identificationModule': {'nctId': 'NCT05265468', 'briefTitle': 'Noninvasive Treatment of Upper Trapezius Active Trigger Points in College Students With Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Católica San Antonio de Murcia'}, 'officialTitle': 'Noninvasive Treatment of Upper Trapezius Active Trigger Points in College Students With Neck Pain. A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'CE112103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Jones Group (Strain Counterstrain)', 'description': 'Jones Group consist in 90 seconds in a ralease positioning of no pain in muscle acortation', 'interventionNames': ['Other: Jones Group (Strain Counterstrain)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lewit Group', 'description': 'Lewit Group consist in a maximum of four minutes of muscular contraction acompaind by stretching techniques', 'interventionNames': ['Other: Lewit Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chaitow Group', 'description': 'Chaitow Group consist in a maximum of four minutes of muscular contraction acompaind by stretching techniques and deep diaphragmatic respiration', 'interventionNames': ['Other: Chaitow Group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Placebo Group only have to mantain no pain positioning for 3 minutes', 'interventionNames': ['Other: Placebo Group']}], 'interventions': [{'name': 'Jones Group (Strain Counterstrain)', 'type': 'OTHER', 'description': 'No pain positioning technique with diaphragmatic breathing', 'armGroupLabels': ['Jones Group (Strain Counterstrain)']}, {'name': 'Lewit Group', 'type': 'OTHER', 'description': 'Isometric muscular exercise acompained with stretching technique', 'armGroupLabels': ['Lewit Group']}, {'name': 'Chaitow Group', 'type': 'OTHER', 'description': 'Isometric muscular exercise acompained with stretching technique and diaphragmatic breathing', 'armGroupLabels': ['Chaitow Group']}, {'name': 'Placebo Group', 'type': 'OTHER', 'description': 'No pain positioning of participants', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30107', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Universidad Católica de Murcia', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Católica San Antonio de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Director', 'investigatorFullName': 'Juan Martínez Fuentes', 'investigatorAffiliation': 'Universidad Católica San Antonio de Murcia'}}}}