Effects of Close Follow-up on Patients With Low Back Pain

Istanbul Training and Research Hospital

Status: Enrolling

Conditions: Low Back Pain, Mechanical; Low Back Pain

Treatments: Behavioral: Close follow-up by a physician; Other: Conventional physical therapy program

Study type: Interventional

Funder types: Other

Identifiers

NCT07150702

16/05/2025 2011-KAEK-50;114;

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18-65 with subacute or chronic mechanical back pain and considered appropriate for a physical therapy program.

Exclusion criteria

• Patients describing inflammatory back pain
• Spondyloarthropathies and other rheumatological diseases
• History of spinal surgery
• Patients with sensory disturbances and psychiatric diagnoses
• Fibromyalgia
• Patients with malignancies
• Patients with active infectious findings
• Patients with a history of radiotherapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

Group 1: Conventional physical therapy program

Active Comparator group

Treatment:

Other: Conventional physical therapy program

Group 2: Conventional physical therapy program with close follow-up by a physician

Active Comparator group

Treatment:

Other: Conventional physical therapy program

Behavioral: Close follow-up by a physician