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

NCT07150702 | Recruiting

• 1 other identifier: 16/05/2025;2011-KAEK-50;114
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain; Low Back Pain, Mechanical

Keywords

low back pain; physical therapy; mechanical low back pain; pain management

Outcome Measures

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.

  It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.

Secondary Outcomes (5)

• Tampa Scale of Kinesiophobia

  It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.

• The Pain Catastrophizing Scale

  It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.

• Beck Depression Inventory

  It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.

• Roland-Morris Disability Questionnaire

  It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.

• Leeds Assessment of Neuropathic Symptoms and Signs

  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

  It will be evaluated in the baseline

Study Arms (2)

Group 1: Conventional physical therapy program

ACTIVE COMPARATOR

Other: Conventional physical therapy program

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

ACTIVE COMPARATOR

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

Interventions

Conventional physical therapy program OTHER

Conventional physical therapy program that includes hot packs, transcutaneous electrical nerve stimulation, ultrasound, and core stabilization exercises

Group 1: Conventional physical therapy program; Group 2: Conventional physical therapy program with close follow-up by a physician

Close follow-up by a physician BEHAVIORAL

Daily physician-patient meetings during the sessions

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, Fatih, 34093, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Agnosia

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 2, 2025
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 10, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

TU (1)