Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-27 @ 12:18 AM
Study NCT ID:
NCT04420403
Status:
COMPLETED
Last Update Posted:
2022-01-04
First Post:
2020-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Effectiveness of Manual Therapy Plus Cervical Stabilization Exercise in Chronic Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomly assigned to manual therapy plus cervical stabilization exercise group (intervention group) and only the manual therapy group (control group).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-14', 'studyFirstSubmitDate': '2020-05-29', 'studyFirstSubmitQcDate': '2020-06-04', 'lastUpdatePostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Balance', 'timeFrame': 'change from baseline at 6 weeks', 'description': "The balance will be evaluated with Biodex BioSwayTM Balance Evaluation System. It reliably measures the patient's ability to balance on soft and/or hard ground."}], 'secondaryOutcomes': [{'measure': 'Proprioception', 'timeFrame': 'change from baseline at 6 weeks', 'description': 'Proprioception will be assessed with dual digital inclinometer. The feet of the inclinometers will be placed as simultaneously as possible over the head of the patients and the cervical seventh vertebra. Firstly, patients will be asked to move their heads forward as possible as from the neutral position and then they will try to find neutral position from reached position. The angle on digital display of inclinometer will be recorded as degree. Each test will be repeated 3 times and the average deviation error score will be recorded.'}, {'measure': 'Muscle morphology', 'timeFrame': 'change from baseline at 6 weeks', 'description': 'The thickness and stiffness of the neck muscles will be evaluated by a specialist radiologist with real-time ultrasonography. It is a reliable, valid and, non-invasive method that provides an assessment of muscle morphology. Measurements will be made by using the Logiq S7 / Expert ultrasound device. The cross-sectional area of deep neck muscle with sonography, the stiffness of the superficial muscles with elastography were assessed.'}, {'measure': 'Pain intensity', 'timeFrame': 'change from baseline at 6 weeks', 'description': 'The pain intensity will be assessed with the Visual Analog Scale, which consists of a horizontal line of 10 cm in length. For pain level assessment, "0" defines "no pain" and "10" defines "unbearable pain\'\'. The participants will be asked to mark the intensity of their pain level.'}, {'measure': 'Disability level', 'timeFrame': 'change from baseline at 6 weeks', 'description': 'The disability level will be measured with the Turkish version of Neck Disability Index (NDI). It consists of 10 sections which include the severity of pain, personal care, lifting, reading, headache, concentration, work-life, driving, sleeping and leisure activities. There are 6 responses for each section, scored 0 (no pain and no functional limitation) and 5 (worst pain and maximum limitation). The total score ranges from 0 to 50. Patients will be asked to select the most appropriate option for each section.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neck pain', 'manual therapy', 'exercise', 'postural control'], 'conditions': ['Neck Pain']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effectiveness of manual therapy plus cervical stabilization exercise compared to manual therapy alone on balance, proprioception, and neck muscle morphology in chronic neck pain.', 'detailedDescription': 'Neck pain is defined as pain and/or stiffness localized to the dorsal area of the area between the condyle of the occiput and the third thoracic vertebra. Chronic neck pain (CNP), defined as persistent pain lasting three or more mounts, causes disability and a reduction in life quality. Balance disorders or postural instability, a deficit in proprioception, changes in muscle recruitment, a decrease in dimension of deep cervical muscle, and an increase in stiffness of superficial neck muscle may lead to pain in patients with CNP. Both manual therapy and exercise have favorable effects on management with CNP. According to our knowledge, no study has investigated the effects of manual therapy plus cervical stabilization exercise on balance, proprioception, and neck muscle morphology in CNP, yet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20 to 55 years of age,\n* Having generalized neck pain for more than 3 months,\n* Being volunteer\n\nExclusion Criteria:\n\n* Being pregnant,\n* Malignancy,\n* Having cervical stenosis,\n* Severe cervical spondylosis,\n* Cervical fractures and tumor,\n* Osteoporosis,\n* Positive vertebrobasilar test\n* Positive Babinski reflex\n* Neurologic deficit related to compression of the spinal root or cord,\n* Having neurologic, dermatologic, infectious, inflammatory rheumatologic and endocrine diseases,\n* Being an inability to fulfill the questionnaires,\n* Any problems that will hinder exercise (advanced cardiopulmonary or orthopedic problems), having intervention including exercise program or physiotherapy in the three months'}, 'identificationModule': {'nctId': 'NCT04420403', 'briefTitle': 'Investigation of the Effectiveness of Manual Therapy Plus Cervical Stabilization Exercise in Chronic Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk Training and Research Hospital'}, 'officialTitle': 'Investigation of the Effectiveness of Manual Therapy Plus Cervical Stabilization Exercise on Balance, Proprioception, and Neck Muscle Morphology in Chronic Neck Pain', 'orgStudyIdInfo': {'id': '2020/05/28'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Manual therapy plus cervical stabilization exercise group', 'description': 'The patients diagnosed with chronic neck pain (CNP) with 18-55 years of age followed by routine controls and who were volunteered will be included in the study.', 'interventionNames': ['Other: Manual Therapy', 'Other: Cervical Stabilazation Exercise (CSE)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Only manual therapy group', 'description': 'The patients diagnosed with CNP with 18-55 years of age followed by routine controls and who were volunteered will be included in the study.', 'interventionNames': ['Other: Manual Therapy']}], 'interventions': [{'name': 'Manual Therapy', 'type': 'OTHER', 'description': "Cyriax's mobilization techniques will be applied as manual therapy. Before the mobilization, soft tissue mobilization techniques will be applied to relieve muscular spasm and preventing the patient' s anxiety. Bringing, manual traction, manual traction with rotation, manual traction with anterior-posterior gliding and lateral gliding mobilization techniques will be applied. Appropriate mobility techniques will be selected according to the complaints and symptoms of the patients. Cervical mobilization applications will take an average of 15-20 minutes.", 'armGroupLabels': ['Manual therapy plus cervical stabilization exercise group', 'Only manual therapy group']}, {'name': 'Cervical Stabilazation Exercise (CSE)', 'type': 'OTHER', 'description': 'The CSE program aims to maintain a neutral spine position and activate deep cervical muscles during exercises. It is performed in stages with gradual progression according to the stages of motor learning and sensory-motor integration, namely, static, dynamic, and functional. The program will start with postural training and then the cervical bracing technique with the activation of deep neck flexors for CSE was performed. The patients will be asked to maintain a neutral spine during the exercises and throughout the day as much as possible. The difficulty and variety of exercises will be increased weekly. It will be carried out 2 days a week for 6 weeks (12 sessions) by the supervisor physiotherapist.', 'armGroupLabels': ['Manual therapy plus cervical stabilization exercise group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06760', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Yildirim Beyazit University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'seyda toprak celenay, PhD, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara Yildirim Beyazıt University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Seyda TOPRAK CELENAY', 'investigatorAffiliation': 'Ataturk Training and Research Hospital'}}}}