Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-07 @ 11:16 AM
Study NCT ID:
NCT02424032
Status:
UNKNOWN
Last Update Posted:
2015-04-22
First Post:
2015-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stabilization Exercises With and Without Connective Tissue Massage for 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': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 53}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'lastUpdateSubmitDate': '2015-04-18', 'studyFirstSubmitDate': '2015-04-08', 'studyFirstSubmitQcDate': '2015-04-18', 'lastUpdatePostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Neck pain intensity as measured by Visual Analog Scale', 'timeFrame': 'Change from baseline neck pain intensity at 4 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in level of anxiety as assessed by Spielberger State Trait Anxiety Inventory', 'timeFrame': 'Change from baseline level of anxiety at 4 weeks'}, {'measure': 'Change in quality of life as assessed by Short Form-36', 'timeFrame': 'Change from baseline quality of life at 4 weeks'}, {'measure': 'Change in pressure pain threshold as measured by digital algometer', 'timeFrame': 'Change from baseline pressure pain threshold at 4 weeks'}]}, 'conditionsModule': {'keywords': ['Neck pain', 'stabilization exercise', 'connective tissue massage'], 'conditions': ['Neck Pain Musculoskeletal']}, 'referencesModule': {'references': [{'pmid': '25108749', 'type': 'RESULT', 'citation': 'Bakar Y, Sertel M, Ozturk A, Yumin ET, Tatarli N, Ankarali H. Short term effects of classic massage compared to connective tissue massage on pressure pain threshold and muscle relaxation response in women with chronic neck pain: a preliminary study. J Manipulative Physiol Ther. 2014 Jul-Aug;37(6):415-21. doi: 10.1016/j.jmpt.2014.05.004. Epub 2014 Aug 6.'}, {'pmid': '19565156', 'type': 'RESULT', 'citation': 'Dusunceli Y, Ozturk C, Atamaz F, Hepguler S, Durmaz B. Efficacy of neck stabilization exercises for neck pain: a randomized controlled study. J Rehabil Med. 2009 Jul;41(8):626-31. doi: 10.2340/16501977-0392.'}, {'pmid': '12221344', 'type': 'RESULT', 'citation': 'Jull G, Trott P, Potter H, Zito G, Niere K, Shirley D, Emberson J, Marschner I, Richardson C. A randomized controlled trial of exercise and manipulative therapy for cervicogenic headache. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1835-43; discussion 1843. doi: 10.1097/00007632-200209010-00004.'}, {'pmid': '19333174', 'type': 'RESULT', 'citation': 'Sherman KJ, Cherkin DC, Hawkes RJ, Miglioretti DL, Deyo RA. Randomized trial of therapeutic massage for chronic neck pain. Clin J Pain. 2009 Mar-Apr;25(3):233-8. doi: 10.1097/AJP.0b013e31818b7912.'}, {'pmid': '26211422', 'type': 'DERIVED', 'citation': 'Celenay ST, Kaya DO, Akbayrak T. Cervical and scapulothoracic stabilization exercises with and without connective tissue massage for chronic mechanical neck pain: A prospective, randomised controlled trial. Man Ther. 2016 Feb;21:144-50. doi: 10.1016/j.math.2015.07.003. Epub 2015 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to investigate and compared the effects of cervical and scapulothoracic stabilization exercises with and without connective tissue massage (CTM) for patients with chronic mechanical neck pain.', 'detailedDescription': "Sixty patients with chronic mechanical neck pain were recruited and randomly allocated into stabilization exercise with and without the connective tissue massage program. The study's inclusion criteria were as follows: 18 to 65 years of age, having neck pain for more than 3 months, and being volunteer. The exclusion criteria were as follows: stenosis, traumatic injury history, previous surgery related to cervical spine, hypermobility, cancer, having inflammatory rheumatologic, severe psychological disorders, being pregnant, and intervention including exercise or physical therapy in the last 3 months.The program was carried out for 12 sessions, 3 days/week in 4 weeks. Pain intensity with Visual Analog Scale, pressure pain threshold with digital algometer, the level of anxiety with the Spielberger State Trait Anxiety Inventory, and life quality with Short Form-36 were evaluated before and after treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 65 years of age,\n* having neck pain for more than 3 months, and\n* being volunteer\n\nExclusion Criteria:\n\n* Stenosis,\n* traumatic injury history,\n* previous surgery related to cervical spine,\n* hypermobility,\n* cancer,\n* having inflammatory rheumatologic,\n* severe psychological disorders,\n* being pregnant, and\n* intervention including exercise or physical therapy in the last 3 months'}, 'identificationModule': {'nctId': 'NCT02424032', 'briefTitle': 'Stabilization Exercises With and Without Connective Tissue Massage for Chronic Mechanical Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk Training and Research Hospital'}, 'orgStudyIdInfo': {'id': 'GO 13/381'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise and connective tissue massage', 'description': 'Stabilization exercise and connective tissue massage have been applied', 'interventionNames': ['Behavioral: "Exercise" and "connective tissue massage"']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise', 'description': 'Only stabilization exercise has been applied', 'interventionNames': ['Behavioral: "Exercise"']}], 'interventions': [{'name': '"Exercise" and "connective tissue massage"', 'type': 'BEHAVIORAL', 'description': 'Cervical and scapulothoracic stabilization exercises with connective tissue massage were performed.The program was carried out for 12 sessions, 3 days/week in 4 weeks.', 'armGroupLabels': ['Exercise and connective tissue massage']}, {'name': '"Exercise"', 'type': 'BEHAVIORAL', 'description': 'Cervical and scapulothoracic stabilization exercises were performed. The program was carried out for 12 sessions, 3 days/week in 4 weeks.', 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Ankara', 'state': 'Cankaya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Seyda - TOPRAK CELENAY, Assist. Prof', 'role': 'CONTACT', 'email': 'sydtoprak@hotmail.com', 'phone': '+90 0534 041 39 86'}, {'name': 'Derya - OZER KAYA, Assoc. Prof', 'role': 'CONTACT', 'email': 'deryaozer2000@yahoo.com', 'phone': '+90 232 329 35 13', 'phoneExt': '4711'}], 'facility': 'Ataturk Trainning and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Ankara', 'state': 'Cankaya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Seyda TOPRAK CELENAY', 'role': 'CONTACT', 'email': 'sydtoprak@hotmail.com', 'phone': '490-534-041-3986'}], 'facility': 'Ataturk Trainning and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Seyda TOPRAK CELENAY', 'role': 'CONTACT', 'email': 'sydtoprak@hotmail.com', 'phone': '+90-534-041-3986'}, {'name': 'Derya OZER KAYA', 'role': 'CONTACT', 'email': 'deryaozer2000@yahoo.com', 'phone': '+90-232-329-3513', 'phoneExt': '4711'}], 'overallOfficials': [{'name': 'Seyda TOPRAK CELENAY', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ataturk Trainning and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seyda TOPRAK CELENAY', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Seyda TOPRAK CELENAY', 'investigatorAffiliation': 'Ataturk Training and Research Hospital'}}}}