Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT06256016
Status:
RECRUITING
Last Update Posted:
2025-06-03
First Post:
2024-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Massage of the Thoracic Region in Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-01', 'studyFirstSubmitDate': '2024-02-04', 'studyFirstSubmitQcDate': '2024-02-12', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neck pain', 'timeFrame': 'Change from Baseline pain at 3 month', 'description': 'A Visual Analogue Scale (VAS) is one of the pain rating scales used for measure the intensity pain. The VAS is a straight horizontal line of fixed length, usually 100 mm.The ends are defined as the extreme limits of the parameter to be measured orientated from the left or "10" (worst pain) to the right (best pain) or "0".'}], 'secondaryOutcomes': [{'measure': 'Neck disability index', 'timeFrame': 'Change from Baseline pain at 3 month', 'description': 'This questionnaire has been designed to give us information as to how the neck pain are affecting the subject´s ability to manage in everyday life. The questionnaire has 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. It´s interpreted as a raw score, with a maximum score of 50 where "0" is not disability and 50 is the worst disability'}, {'measure': 'Pain catastrophizing', 'timeFrame': 'Change from Baseline pain at 3 month', 'description': 'Pain Catastrophizing Scale (PCS). The PCS is a 13-item instrumen that task participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time. The PCS total scores range from 0 - 52. 0 is the best result and 52 is the worst result.'}, {'measure': 'kinesiophobia', 'timeFrame': 'Change from Baseline pain at 3 month', 'description': 'The Tampa Scale of Kinesiophobia (TSK) describe patient circumstances characterised by an "excessive, irrational, and debilitating fear of physical movement and activity resulting from a feeling of vulnerability to painful injury or reinjury. The TSK is a 17 item assessment checklist.The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia.'}, {'measure': 'The Global Rating of Change (GRoC)', 'timeFrame': 'Change from Baseline pain at 3 month', 'description': "It's a scale that assesses whether the patient condition has gotten worse, better, or stayed the same and to quantify the magnitude of that change, typically following treatment.Subjects will make global ratings of changes regarding their level of well-being from their neck pain since the initial examination on a 15-point self-report scale (from -7 to 7), where -7 is the worst possible value and 7 is the best possible value."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neck Pain']}, 'descriptionModule': {'briefSummary': 'Neck pain is a common disorder in industrialized countries. Manual therapy techniques have been commonly used in the treatment of this problem. Actually, there is no research work that has evaluated the work well of treatment with soft tissue techniques (massage) applied to the dorsal paravertebral muscle in the management of neck pain. The goal of this study (clinical trial) is to compare the efficacy of a massage protocol performed on the dorsal region in subjects with mechanical neck pain.\n\nThe researchers will compare:\n\nA group that will be treated with a local protocol of cervical manual therapy and therapeutic exercise along with the treatment(massage) of the thoracic region.\n\nAnother group that will be treated only with a local protocol of cervical manual therapy and therapeutic exercise.\n\nIt is to see if the inclusion of treatment of the thoracic region improves the local intervention in cervical region.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with neck pain.\n* Pain between 4 and 7 points according to a visual anological scale.\n* Neck pain lasting more than three months\n\nExclusion Criteria:\n\n* Subjects who have suffered a whiplash injury.\n* Subjects with neck pain and upper extremity pain.\n* Subjects with a diagnosis of herniated disc.\n* Subjects with fibromyalgia.\n* Subjects with any cancer process.'}, 'identificationModule': {'nctId': 'NCT06256016', 'briefTitle': 'Effectiveness of Massage of the Thoracic Region in Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Alcala'}, 'officialTitle': 'Application of Massage to the Dorsal Paravertebral Muscles and Its Efficacy in the Treatment of Neck Pain', 'orgStudyIdInfo': {'id': 'CEI15/002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neck pain massage', 'description': 'Subjects in this group will be treated with a neck muscle massage protocol.', 'interventionNames': ['Other: Neck pain massage']}, {'type': 'EXPERIMENTAL', 'label': 'Neck and thoracic massage', 'description': 'Subjects in this group will be treated with a massage protocol of the neck muscles and the posterior thoracic region.', 'interventionNames': ['Other: Neck and thoracic massage']}], 'interventions': [{'name': 'Neck pain massage', 'type': 'OTHER', 'description': 'Subjects in this group will be treated with a neck muscle massage protocol. First, pressure inhibition techniques will be applied to the affected muscles. Then deep stroke technique will be performed on each muscle.\n\nIn addition, effleurages technique will be applied along the thoracic paravertebral muscle.\n\nSubjects will also perform an exercise protocol for neck pain.', 'armGroupLabels': ['Neck pain massage']}, {'name': 'Neck and thoracic massage', 'type': 'OTHER', 'description': 'Subjects in this group will be treated with a neck muscle massage protocol. First, pressure inhibition techniques will be applied to the affected muscles. Then deep stroke technique will be performed on each muscle.\n\nIn addition, deep stroke technique will be applied along the thoracic paravertebral muscle.\n\nSubjects will also perform an exercise protocol for neck pain.', 'armGroupLabels': ['Neck and thoracic massage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28805', 'city': 'Alcalá de Henares', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Laura López Pérez, Mrs', 'role': 'CONTACT', 'email': 'gifyd@uah.es', 'phone': '+34683378391'}], 'facility': 'Physioterapy and Pain center research', 'geoPoint': {'lat': 40.48205, 'lon': -3.35996}}], 'centralContacts': [{'name': 'Patricia Martinez-Merinero, PhD', 'role': 'CONTACT', 'email': 'gifyd@uah.es', 'phone': '+34 8855142'}], 'overallOfficials': [{'name': 'Daniel Pecos-Martin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alcala University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alcala', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Prof. Dr. Daniel Pecos Martín', 'investigatorAffiliation': 'University of Alcala'}}}}