Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-02-22 @ 3:56 PM
Study NCT ID:
NCT02832232
Status:
UNKNOWN
Last Update Posted:
2017-08-31
First Post:
2016-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Specific Manual Approach to the Suboccipital Area on 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': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-30', 'studyFirstSubmitDate': '2016-07-06', 'studyFirstSubmitQcDate': '2016-07-13', 'lastUpdatePostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Pain intensity', 'timeFrame': 'Baseline -3 weeks - 3 months', 'description': 'Changes from Baseline in Pain intensity at 3 weeks and 3 months. Measure instrument: Visual Analogue Scale (VAS)'}], 'secondaryOutcomes': [{'measure': 'Changes in Neck disability', 'timeFrame': 'Baseline -3 weeks - 3 months', 'description': 'Changes from Baseline in Neck disability at 3 weeks and 3 months. Measure instrument: Neck disability index questionnaire (NDI)'}, {'measure': 'Changes in Range of motion', 'timeFrame': 'Baseline -3 weeks - 3 months', 'description': 'Changes from Baseline in Range of Motion at 3 weeks and 3 months. Measure instrument: Cervical Range of Motion (CROM) device.'}, {'measure': 'Patient perception of change at short term', 'timeFrame': '3 weeks after recruitment', 'description': 'Measure instrument: Global Rating of Change scale (GROC-scale)'}, {'measure': 'Patient perception of change at middle term', 'timeFrame': '3 weeks after discharge', 'description': 'Measure instrument: Global Rating of Change scale (GROC-scale)'}, {'measure': 'Headache disability at short term', 'timeFrame': '3 weeks after recruitment', 'description': 'Measure instrument: Headache impact test (HIT-6)'}, {'measure': 'Headache disability at middle term', 'timeFrame': '3 weeks after discharge', 'description': 'Measure instrument: Headache impact test (HIT-6)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Physiotherapy', 'Manual Therapy', 'Neck Pain'], 'conditions': ['Neck Pain']}, 'referencesModule': {'references': [{'pmid': '33076707', 'type': 'DERIVED', 'citation': 'Gonzalez-Rueda V, Lopez-de-Celis C, Bueno-Gracia E, Rodriguez-Sanz J, Perez-Bellmunt A, Barra-Lopez ME, Hidalgo Garcia C. "Short- and mid-term effects of adding upper cervical manual therapy to a conventional physical therapy program in patients with chronic mechanical neck pain. Randomized controlled clinical trial.". Clin Rehabil. 2021 Mar;35(3):378-389. doi: 10.1177/0269215520965054. Epub 2020 Oct 19.'}, {'pmid': '28870191', 'type': 'DERIVED', 'citation': 'Gonzalez Rueda V, Lopez de Celis C, Barra Lopez ME, Carrasco Uribarren A, Castillo Tomas S, Hidalgo Garcia C. Effectiveness of a specific manual approach to the suboccipital region in patients with chronic mechanical neck pain and rotation deficit in the upper cervical spine: study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2017 Sep 5;18(1):384. doi: 10.1186/s12891-017-1744-5.'}]}, 'descriptionModule': {'briefSummary': 'There are different inhibition suboccipital techniques, usually adjuvant of physiotherapy, for treatment of patients with chronic neck pain. In our clinical practice, a favorable effect is observed on patients with chronic neck pain, but there are no published studies evaluating the results of this techniques on pain, mobility and disability.\n\nThe objective of this trial is to evaluate if the suboccipital manual techniques, provides further improvement in pain intensity, neck disability, range of motion, on patients with chronic mechanical neck pain and rotation deficit of the upper cervical spine, being treated with physiotherapy. For this purpose, investigators conduct a double-blind (patient and evaluator) randomized controlled trial, in a Public Primary Care Center.\n\nSeventy four subjects will be randomized (computer application) into three groups: Mobilization Group, Maintained pressure Group and Control Group. All the three groups receive the same protocolized physiotherapeutic treatment during three weeks and, additionally, the Mobilization Group receives six sessions (two sessions in a week during three weeks) of translational dorsal glide mobilization technique grade III of the atlanto-occipital joint and the Maintained pressure Group receives six sessions (two sessions in a week during three weeks) of pressure maintained suboccipital Inhibition technique. The Control Group receives the protocolized physiotherapeutic treatment only.\n\nPain intensity (VAS), Neck Disability Index (NDI), Range of motion (CROM), will be measured at baseline, after treatment period, and three months after discharge from treatment. After discharge for treatment the patient subjective opinion about their evolution will be collected through a Global Rating of Change (GROC) scale, and evaluation of headache disability (HIT-6).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of chronic mechanical neck pain.\n* Flexion-rotation test positive (less of 32 degrees or 10 degrees difference between the two sides)\n* Sign the informed consent form.\n\nExclusion Criteria:\n\n* Presenting one or more positive safety cervical test .\n* Carriers of pacemaker or defibrillators.\n* Previous history of severe trauma to the cervical region of the spine.\n* Inflammatory arthritis.\n* Inability to maintain supine position.\n* Inability to tolerate flexion-rotation test\n* Poor Language and communication skills making difficult to understand the informed consent.\n* Pending litigation or legal claim.'}, 'identificationModule': {'nctId': 'NCT02832232', 'briefTitle': 'Specific Manual Approach to the Suboccipital Area on Patients With Chronic Mechanical Neck Pain', 'organization': {'class': 'OTHER', 'fullName': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina"}, 'officialTitle': 'Effectiveness of a Manual Specific Approach to the Suboccipital Area on Pain, Range of Motion, Disability and Clinical Significance of Changes on Patients With Chronic Mechanical Neck Pain and Rotation Deficit of the Upper Cervical Spine', 'orgStudyIdInfo': {'id': 'P16/068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mobilization Group', 'description': 'translational dorsal glide mobilization technique grade III and Protocolized Physiotherapy', 'interventionNames': ['Other: translational dorsal glide mobilization technique grade III', 'Other: Control Group']}, {'type': 'EXPERIMENTAL', 'label': 'Maintained pressure Group', 'description': 'pressure maintained suboccipital inhibition technique and Protocolized Physiotherapy', 'interventionNames': ['Other: pressure maintained suboccipital Inhibition technique', 'Other: Control Group']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'Protocolized Physiotherapy', 'interventionNames': ['Other: Control Group']}], 'interventions': [{'name': 'translational dorsal glide mobilization technique grade III', 'type': 'OTHER', 'description': "Translational dorsal glide mobilization technique grade III of the atlanto-occipital joint, it is a mobilization technique of Orthopedic Manual therapy according to Kaltenborn-Evjenth concept. The aim is to produce a dorsal glide of the occipital on the atlas, which will be held back by the therapist's hand, producing a stretch component of the suboccipital muscles.\n\nAnd Protocolized physiotherapeutic treatment: Three weeks of daily sessions (five a week) of stretching exercises, thermotherapy and postural education.", 'armGroupLabels': ['Mobilization Group']}, {'name': 'pressure maintained suboccipital Inhibition technique', 'type': 'OTHER', 'description': 'Pressure maintained suboccipital Inhibition technique is aimed to inhibit the tone of the suboccipital muscles. Although some dorsal occipital glide is produced by the weight of the head itself, the main effect is on the muscles due to dorsally pressure is not added to the occipital.\n\nAnd Protocolized physiotherapeutic treatment: Three weeks of daily sessions (five a week) of stretching exercises, thermotherapy and postural education.', 'armGroupLabels': ['Maintained pressure Group']}, {'name': 'Control Group', 'type': 'OTHER', 'description': 'Protocolized physiotherapeutic treatment: Three weeks of daily sessions (five a week) of stretching exercises, thermotherapy and postural education.', 'armGroupLabels': ['Control Group', 'Maintained pressure Group', 'Mobilization Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08940', 'city': 'Cornellà de Llobregat', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Vanessa González, M.Sc.', 'role': 'CONTACT', 'email': 'vgr1980@gmail.com', 'phone': '646619704'}], 'facility': 'Catalan Institut of Health - Sant Ildefons Rehabilitation Center', 'geoPoint': {'lat': 41.35, 'lon': 2.08333}}], 'centralContacts': [{'name': 'Vanessa González, M.Sc.', 'role': 'CONTACT', 'email': 'vgr1980@gmail.com', 'phone': '646619704'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}