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

NCT ID: NCT07150702

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2025-12-10

Brief Summary

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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.

Detailed Description

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Conditions

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Low Back Pain Low Back Pain, Mechanical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group 1: Conventional physical therapy program

Group Type ACTIVE_COMPARATOR

Conventional physical therapy program

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

Conventional physical therapy program

Intervention Type OTHER

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

Close follow-up by a physician

Intervention Type BEHAVIORAL

Daily physician-patient meetings during the sessions

Interventions

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Conventional physical therapy program

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

Intervention Type OTHER

Close follow-up by a physician

Daily physician-patient meetings during the sessions

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hüdanur Coşkun

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul Training and Research Hospital

Istanbul, Fatih, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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Hüdanur Coşkun, M.D.

Role: primary

+905398477387

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id

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