Effects of Close Follow-up on Patients With Low Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIstanbul Training and Research Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18-65 with subacute or chronic mechanical back pain and considered appropriate for a physical therapy program.
Disqualifiers
Patients describing inflammatory back pain
Spondyloarthropathies and other rheumatological diseases
History of spinal surgery
Patients with sensory disturbances and psychiatric diagnoses
Trial design
Design model
Parallel
Treatments tested in this trial
Conventional physical therapy program
Other interventionConventional physical therapy program that includes hot packs, transcutaneous electrical nerve stimulation, ultrasound, and core stabilization exercises
Close follow-up by a physician
BehavioralDaily physician-patient meetings during the sessions
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: Group 1: Conventional physical therapy programActive comparator 1 intervention
Group B: Group 2: Conventional physical therapy program with close follow-up by a physicianActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Visual Analog Scale
Visual Analog Scale (VAS) score ranges from 0 to 10. High scores describe more pain, and low scores describe less pain.
Time frame
It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.Secondary outcomes
1
Tampa Scale of Kinesiophobia
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.
Time frame
It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.2
The Pain Catastrophizing Scale
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.
Time frame
It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.3
Beck Depression Inventory
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.
Time frame
It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.4
Roland-Morris Disability Questionnaire
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.
Time frame
It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.Other outcomes
1
STarT Back Screening Tool
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.
Time frame
It will be evaluated in the baselineSponsors and contacts
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Source ClinicalTrials.gov