Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT07150702
Status:
RECRUITING
Last Update Posted:
2025-09-16
First Post:
2025-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Close Follow-up on Patients With Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized into two groups: the study group and the control group. Patients in the control group will undergo a conventional physical therapy program that includes hot packs, transcutaneous electrical nerve stimulation, ultrasound, and core stabilization exercises. Patients in the study group will undergo daily close follow-up physician-patient meetings during the sessions, in addition to the conventional physical therapy program applied to the control group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-13', 'studyFirstSubmitDate': '2025-08-25', 'studyFirstSubmitQcDate': '2025-08-25', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'STarT Back Screening Tool', 'timeFrame': 'It will be evaluated in the baseline', 'description': "The STarT Back Screening Tool is an assessment tool used to evaluate risk factors and potential functional limitations in individuals experiencing low back pain. The scale typically consists of 9 items, each addressing psychosocial factors, pain intensity, and functional capacity related to the individual's back pain. Scores range from a minimum of 0 to a maximum of 9. Higher scores indicate more severe back pain and an increased presence of psychosocial risk factors, while lower scores suggest lower risk and fewer functional limitations."}], 'primaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': 'It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.', 'description': 'Visual Analog Scale (VAS) score ranges from 0 to 10. High scores describe more pain, and low scores describe less pain.'}], 'secondaryOutcomes': [{'measure': 'Tampa Scale of Kinesiophobia', 'timeFrame': 'It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.', 'description': 'The Tampa Scale of Kinesiophobia is an assessment tool typically consisting of 17 items that evaluates how much fear or anxiety individuals experience regarding movement, exercise, or physical activity. The scale ranges from a minimum score of 0 to a maximum score of 51. Higher scores indicate greater kinesiophobia (fear of movement), while lower scores reflect less fear and anxiety.'}, {'measure': 'The Pain Catastrophizing Scale', 'timeFrame': 'It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.', 'description': 'The Pain Catastrophizing Scale is an assessment tool that evaluates how individuals perceive pain and the level of negative thoughts and anxiety they experience related to pain. The scale typically consists of 13 items, assessing the extent to which a person catastrophizes or experiences excessive worry about their pain. Scores range from a minimum of 0 to a maximum of 52. Higher scores indicate that the individual evaluates pain in a more negative and catastrophic manner, while lower scores suggest lower levels of anxiety and catastrophizing.'}, {'measure': 'Beck Depression Inventory', 'timeFrame': 'It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.', 'description': "The Beck Depression Inventory is a widely used psychometric tool for assessing the severity of an individual's depression. The scale typically consists of 21 items, each evaluating different emotional, physical, and behavioral symptoms associated with depression. Scores range from a minimum of 0 to a maximum of 63. Higher scores indicate more severe depression symptoms, while lower scores suggest fewer or less intense depressive symptoms."}, {'measure': 'Roland-Morris Disability Questionnaire', 'timeFrame': 'It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.', 'description': "The Roland-Morris Disability Questionnaire is an assessment tool designed to evaluate the functional limitations and the impact of low back pain on an individual's daily activities. The questionnaire typically consists of 24 items, each exploring how back pain affects physical activities, functionality, and quality of life. Scores range from a minimum of 0 to a maximum of 24. Higher scores indicate greater disability and more significant limitations in daily life due to back pain, while lower scores suggest fewer functional restrictions."}, {'measure': 'Leeds Assessment of Neuropathic Symptoms and Signs', 'timeFrame': 'It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.', 'description': 'The Leeds Assessment of Neuropathic Symptoms and Signs is an assessment tool designed to evaluate the symptoms of neuropathic pain and the severity of these symptoms. The scale consists of 7 items, each assessing sensory changes, pain type, and the intensity of symptoms related to neuropathic pain. Scores range from a minimum of 0 to a maximum of 24. Higher scores indicate more severe neuropathic pain symptoms, while lower scores suggest milder or no neuropathic pain symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['low back pain', 'physical therapy', 'mechanical low back pain', 'pain management'], 'conditions': ['Low Back Pain', 'Low Back Pain, Mechanical']}, 'descriptionModule': {'briefSummary': "This study will include patients aged 18-65 with subacute or chronic mechanical low back pain who apply to the Physical Medicine and Rehabilitation Clinic. The age, gender, body mass index, duration of low back pain, smoking status, and educational status of the patients included in the study will be recorded. Patients will be randomized into two groups: the study group and the control group. First, the psychosocial risk status of patients in both groups will be determined using the STarT Back Screening Tool. Then, patients in the control group will undergo a conventional physical therapy program that includes hot packs, transcutaneous electrical nerve stimulation, ultrasound, and core stabilization exercises. Patients in the study group will undergo daily close follow-up physician-patient meetings during the sessions, in addition to the conventional physical therapy program applied to the control group. Clinical assessments will be performed using the Visual Analogue Scale (VAS), Tampa Scale of Kinesiophobia, Pain Catastrophizing Scale, Beck's Depression Scale, Roland-Morris Disability Questionnaire, and Leeds Assessment of Neuropathic Symptoms and Signs. Clinical evaluations will be conducted at baseline, on Day 5 post-treatment, and at 1 month post-treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18-65 with subacute or chronic mechanical back pain and considered appropriate for a physical therapy program.\n\nExclusion Criteria:\n\n* Patients describing inflammatory back pain\n* Spondyloarthropathies and other rheumatological diseases\n* History of spinal surgery\n* Patients with sensory disturbances and psychiatric diagnoses\n* Fibromyalgia\n* Patients with malignancies\n* Patients with active infectious findings\n* Patients with a history of radiotherapy'}, 'identificationModule': {'nctId': 'NCT07150702', 'briefTitle': 'Effects of Close Follow-up on Patients With Low Back Pain', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Istanbul Training and Research Hospital'}, 'officialTitle': 'The Effect of Close Follow-up by a Physician in Addition to a Conventional Physical Therapy Program in Patients With Low Back Pain', 'orgStudyIdInfo': {'id': '16/05/2025;2011-KAEK-50;114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1: Conventional physical therapy program', 'interventionNames': ['Other: Conventional physical therapy program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2: Conventional physical therapy program with close follow-up by a physician', 'interventionNames': ['Other: Conventional physical therapy program', 'Behavioral: Close follow-up by a physician']}], 'interventions': [{'name': 'Conventional physical therapy program', 'type': 'OTHER', 'description': 'Conventional physical therapy program that includes hot packs, transcutaneous electrical nerve stimulation, ultrasound, and core stabilization exercises', 'armGroupLabels': ['Group 1: Conventional physical therapy program', 'Group 2: Conventional physical therapy program with close follow-up by a physician']}, {'name': 'Close follow-up by a physician', 'type': 'BEHAVIORAL', 'description': 'Daily physician-patient meetings during the sessions', 'armGroupLabels': ['Group 2: Conventional physical therapy program with close follow-up by a physician']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'state': 'Fatih', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Hüdanur Coşkun, M.D.', 'role': 'CONTACT', 'email': 'hcoskun65@hotmail.com', 'phone': '+905398477387'}], 'facility': 'Istanbul Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hüdanur Coşkun', 'investigatorAffiliation': 'Istanbul Training and Research Hospital'}}}}