Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-03-02 @ 5:51 PM
Study NCT ID:
NCT04268667
Status:
COMPLETED
Last Update Posted:
2024-03-26
First Post:
2020-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Spinal Manipulation Treatments in Patients With Chronic Mechanical 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020393', 'term': 'Manipulation, Spinal'}], 'ancestors': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-23', 'studyFirstSubmitDate': '2020-02-11', 'studyFirstSubmitQcDate': '2020-02-12', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in neck pain at rest: Numeric Pain Rating Scale (0-10)', 'timeFrame': 'Baseline and 7 days post-treatment', 'description': "Neck pain at rest. Measured with the Numeric Pain Rating Scale (0 = ''no pain'' and 10 = ''worst imaginable pain)."}, {'measure': 'Change in neck disability: Neck Disability Index (0-50)', 'timeFrame': 'Baseline and 7 days post-treatment', 'description': 'Neck disability is measured with Neck Disability Index (10 items). A higher score indicates greater disability.'}], 'secondaryOutcomes': [{'measure': 'Change in flexion movement: Cervical Range of Motion device', 'timeFrame': 'Baseline and 7 days post-treatment', 'description': 'Range of cervical motion in flexion. Measured with a Cervical Range of Motion (CROM) device'}, {'measure': 'Change in extension movement: Cervical Range of Motion device', 'timeFrame': 'Baseline and 7 days post-treatment', 'description': 'Range of cervical motion in extension. Measured with a Cervical Range of Motion (CROM) device'}, {'measure': 'Change in rigth lateral flexion movement: Cervical Range of Motion device', 'timeFrame': 'Baseline and 7 days post-treatment', 'description': 'Range of cervical motion in right lateral flexion. Measured with a Cervical Range of Motion (CROM) device'}, {'measure': 'Change in left lateral flexion movement: Cervical Range of Motion device', 'timeFrame': 'Baseline and 7 days post-treatment', 'description': 'Range of cervical motion in left lateral flexion. Measured with a Cervical Range of Motion (CROM) device'}, {'measure': 'Change in right rotation movement: Cervical Range of Motion device', 'timeFrame': 'Baseline and 7 days post-treatment', 'description': 'Range of cervical motion in right rotation. Measured with a Cervical Range of Motion (CROM) device'}, {'measure': 'Change in left rotation movement: Cervical Range of Motion device', 'timeFrame': 'Baseline and 7 days post-treatment', 'description': 'Range of cervical motion in left rotation. Measured with a Cervical Range of Motion (CROM) device'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['disability evaluation', 'musculoskeletal manipulations', 'neck pain', 'spinal manipulation'], 'conditions': ['Neck Pain']}, 'descriptionModule': {'briefSummary': 'There is enough evidence to suggest that the spinal manipulation of the upper cervical spine and cervicothoracic spine are effective in decreasing neck pain. Therefore, the purpose of this randomized controlled trial is to compare the effects of an isolated application of upper cervical spine thrust joint manipulation with the application of a full combination of cervical, cervico-thoracic and thoracic spine thrust joint manipulation on neck pain, disability and cervical range of motion in individuals with chronic mechanical neck pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptom persistence for more than 12 weeks.\n* Age from 18 to 55 years.\n* Localized pain in the cervical spine.\n* Symptoms are caused by cervical movement or sustained postures.\n\nExclusion Criteria:\n\n* Stage acute of symptoms.\n* Any contraindication to cervical spinal manipulation (fracture, osteoporosis, joint infections or vertebrobasilar insufficiency).\n* Patients with previous neck trauma or cervical spine surgery.\n* Patients diagnosed with cervical radiculopathy.\n* Patients diagnosed with fibromyalgia.\n* Have been treated with manual therapy in the last 3 months.\n* Receiving other treatment during the course of the study.'}, 'identificationModule': {'nctId': 'NCT04268667', 'briefTitle': 'Comparison of Two Spinal Manipulation Treatments in Patients With Chronic Mechanical Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Clínica Ciudad de Almería'}, 'officialTitle': 'A Comparative Study Between Cervicothoracic and Upper Cervical Spine Manipulation in Patients With Chronic Mechanical Neck Pain: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'spinal manipulation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Upper cervical spine manipulation group', 'description': 'Spinal thrust joint manipulation on the atlantoaxial joint', 'interventionNames': ['Other: Spinal manipulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cervicothoracic spine manipulations group', 'description': 'Different spinal thrust joint manipulations on the thoracic spine (T6), mid-cervical spine (C3-C4) and cervicothoracic junction (C7-T1).', 'interventionNames': ['Other: Spinal manipulation']}], 'interventions': [{'name': 'Spinal manipulation', 'type': 'OTHER', 'description': 'Application of upper cervical spine thrust joint manipulation or application of a full combination of cervical, cervico-thoracic and thoracic spine thrust joint manipulation.', 'armGroupLabels': ['Cervicothoracic spine manipulations group', 'Upper cervical spine manipulation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04008', 'city': 'Almería', 'country': 'Spain', 'facility': 'Clínica Ciudad de Almería', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}], 'overallOfficials': [{'name': 'Raúl Romero del Rey, Mr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinica Ciudad de Almería'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clínica Ciudad de Almería', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Raúl Romero del Rey', 'investigatorAffiliation': 'Universidad de Almeria'}}}}