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Recruiting NCT07150702

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

No phase Interventional Low Back Pain Low Back Pain, Mechanical

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Conventional physical therapy program, Close follow-up by a physician.
Who it may be relevant to
Registry conditions: Low Back Pain, Low Back Pain, Mechanical. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Effect of Close Follow-up by a Physician in Addition to a Conventional Physical Therapy Program in Patients With Low Back Pain

Overview

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.

Interventions

  • Other Conventional physical therapy program
    Conventional physical therapy program that includes hot packs, transcutaneous electrical nerve stimulation, ultrasound, and core stabilization exercises
  • Behavioral Close follow-up by a physician
    Daily physician-patient meetings during the sessions

Primary outcome measures

  • Visual Analog Scale [Time frame: It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.]
Secondary outcome measures (5)
  • Tampa Scale of Kinesiophobia [Time frame: It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.]
  • The Pain Catastrophizing Scale [Time frame: It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.]
  • Beck Depression Inventory [Time frame: It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.]
  • Roland-Morris Disability Questionnaire [Time frame: 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 [Time frame: It will be evaluated in the baseline,on Day 5 post-treatment, and at 1 month post-treatment.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul Training and Research Hospital — Istanbul

Identifiers

NCT: NCT07150702 · 16/05/2025;2011-KAEK-50;114

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗