Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-01-31 @ 6:50 AM
Study NCT ID:
NCT02451267
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
2015-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Prediction Rules for Identifying Patients With Chronic Neck Pain Who Will Benefit From General Aerobic Exercise
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': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, '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': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-12', 'studyFirstSubmitDate': '2015-05-10', 'studyFirstSubmitQcDate': '2015-05-19', 'lastUpdatePostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global Rating of Change (GROC) scale', 'timeFrame': 'following 6 weeks of treatment, 3 months and 6 months', 'description': 'rating pain severity on a scale from -7 to 7'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Neck Disability Index at 6 weeks', 'timeFrame': 'following 6 weeks of treatment', 'description': 'Questionnaire assessing the individuals disability due to the neck pain'}, {'measure': 'Change from baseline in Fear Avoidance Beliefs Questionnaire', 'timeFrame': 'following 6 weeks of treatment', 'description': 'Questionnaire about the individuals fear that his pain is caused due to movement or work'}, {'measure': 'Change from baseline in cervical range of motion', 'timeFrame': 'following 6 weeks of treatment', 'description': 'active range of motion using inclinometer'}, {'measure': 'long term follow up assessment of VAS', 'timeFrame': '3 months and 6 months', 'description': 'phone assessment of cervical pain severity'}, {'measure': 'long term follow up assessment Neck Disability Index', 'timeFrame': '3 months and 6 months', 'description': 'phone assessment of individuals disability'}, {'measure': 'Change from baseline in Visual Analog Scale (VAS) at 6 weeks', 'timeFrame': 'following 6 weeks of treatment', 'description': 'rating pain severity on a scale from 0-10'}, {'measure': 'headache complaints', 'timeFrame': 'following 6 weeks of treatment, 3 months and 6 months', 'description': 'complains of headache episodes'}, {'measure': 'medication consumption for pain relief', 'timeFrame': 'following 6 weeks of treatment, 3 months and 6 months', 'description': 'how many medication the patient used'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['neck pain', 'aerobic exercise', 'cervical pain'], 'conditions': ['Neck Pain']}, 'referencesModule': {'references': [{'pmid': '24377062', 'type': 'BACKGROUND', 'citation': 'Hanney WJ, Kolber MJ, George SZ, Young I, Patel CK, Cleland JA. Development of a preliminary clinical prediction rule to identify patients with neck pain that may benefit from a standardized program of stretching and muscle performance exercise: a prospective cohort study. Int J Sports Phys Ther. 2013 Dec;8(6):756-76.'}, {'pmid': '19046448', 'type': 'BACKGROUND', 'citation': 'Holth HS, Werpen HK, Zwart JA, Hagen K. Physical inactivity is associated with chronic musculoskeletal complaints 11 years later: results from the Nord-Trondelag Health Study. BMC Musculoskelet Disord. 2008 Dec 1;9:159. doi: 10.1186/1471-2474-9-159.'}, {'pmid': '33730206', 'type': 'DERIVED', 'citation': 'Daher A, Dar G, Carel R. Effectiveness of combined aerobic exercise and neck-specific exercise compared to neck-specific exercise alone on work ability in neck pain patients: a secondary analysis of data from a randomized controlled trial. Int Arch Occup Environ Health. 2021 Oct;94(7):1739-1750. doi: 10.1007/s00420-021-01684-0. Epub 2021 Mar 17.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the effect of aerobic exercise on chronic neck pain. The study will be double blind randomized controlled trial . 120 patients with neck pain will be recruited for the study and divided into a research group and control group. The research group will receive neck exercise program with neck massage and aerobic exercise (leg bicycling with relaxed shoulders) and the control group will receive only neck exercise program with neck massage. Both intervention will be delivered by physiotherapist over 10 treatments and will include a home exercise program. In addition, clinical prediction rule (CPR) for identifying patients with neck pain who will respond better to an aerobic treatment program will be defined.', 'detailedDescription': 'Background:Recently, Hanney et al (2013) derived a preliminary clinical prediction rule (CPR) for identifying patients with neck pain (NP) who may respond to an exercise-based treatment program. These CPRs of neck exercise has not considered aerobic exercise (AE) on NP treatment.\n\nAims of this study: 1) To investigate the effect of aerobic exercise on chronic neck pain;2) To derive a clinical prediction rule for identifying patients with neck pain who may benefit from aerobic treatment program; 3) To determine the prevalence of neck pain in Israel.\n\nStudy Design: Double Blind Randomized controlled trial setting: Outpatients physical therapy clinics of "Clalit Health Services" in Haifa and Western Galilee area.\n\nParticipants: Patients referred to physical therapy with a primary diagnosis of chronic non-specific NP.\n\nMethods: Following a baseline examination in which the subjects\' status on the CPR will be determined, the subjects (CPR positive and negative) will be randomized, divided into a research group and control group. The CPR status will be determined according to Hanney\'s paper (e.g.: neck disability Index score \\< 18/50 ,shoulder protraction, cervical side bending \\< 32°,Fear avoidance belief questionnaire-physical activity score \\< 15, not active on a regular basis on bicycle training). Positive CPR is accordance of having 4/5 these points.\n\nThe baseline examination will include: active and passive cervical range of motion, neurological exam (reflex, sensation, muscle testing), cervical segmental mobility (accessory movement), neck muscle length, cervical manual muscle test and posture assessment.\n\nThe research group will receive neck exercise program with neck massage and AE (leg bicycling with relaxed shoulders) and the control group will receive neck exercise program with neck massage. Both intervention will be delivered by physiotherapist over 10 treatments and will include a home exercise program. Immediate examination will be used at the last treatment (10 treatments), and at 3 and 6 month follow up examination for long-term effects.\n\nIn addition, Data collecting from physiotherapy department in "Clalit Health Services" about statistic of patients with NP who referred to physical therapy including: Prevalence, demographic and profile data'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic neck pain (\\> 30 days)\n* neck disability index \\>10\n* not physical active on a daily basis\n\nExclusion Criteria:\n\n* past history of whiplash injury or cervical surgery\n* pain radiates to the upper limb with neurological deficit (reduced reflex, sensation, muscle strength)\n* complain of vertigo\n* cervical spine diseases: Spondylosis, Spondylolisthesis'}, 'identificationModule': {'nctId': 'NCT02451267', 'briefTitle': 'Clinical Prediction Rules for Identifying Patients With Chronic Neck Pain Who Will Benefit From General Aerobic Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Clalit Health Services'}, 'officialTitle': 'Clinical Prediction Rule for Identifying Patients With Chronic Neck Pain Who Will Benefit From General Aerobic Exercise', 'orgStudyIdInfo': {'id': 'COM-0016-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'positive CPR: research group', 'description': 'physical therapy treatment with aerobic exercise', 'interventionNames': ['Other: physical therapy treatment with aerobic exercise']}, {'type': 'EXPERIMENTAL', 'label': 'negative CPR: research group', 'description': 'physical therapy treatment with aerobic exercise', 'interventionNames': ['Other: physical therapy treatment with aerobic exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'positive CPR: control group', 'description': 'physical therapy treatment', 'interventionNames': ['Other: physical therapy treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'negative CPR: control group', 'description': 'physical therapy treatment', 'interventionNames': ['Other: physical therapy treatment']}], 'interventions': [{'name': 'physical therapy treatment with aerobic exercise', 'type': 'OTHER', 'description': 'neck exercise strengthening program with neck massage and aerobic exercise (leg bicycling with relaxed shoulders)', 'armGroupLabels': ['negative CPR: research group', 'positive CPR: research group']}, {'name': 'physical therapy treatment', 'type': 'OTHER', 'description': 'neck exercise strengthening program with neck massage', 'armGroupLabels': ['negative CPR: control group', 'positive CPR: control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nazareth', 'country': 'Israel', 'facility': 'Clalit Health Service', 'geoPoint': {'lat': 32.70087, 'lon': 35.29719}}], 'overallOfficials': [{'name': 'Gali Dar, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Haifa, Department of Physical Therapy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clalit Health Services', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Haifa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Prof. Refael Carel', 'investigatorAffiliation': 'Clalit Health Services'}}}}