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NCT Number: NCT07150702

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Training and Research Hospital

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location status: Recruiting

Location contact

Hüdanur Coşkun, M.D.

CONTACT

[email protected]

+905398477387

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional physical therapy program

Other

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

Close follow-up by a physician

Behavioral

Daily physician-patient meetings during the sessions

Primary outcomes

  1. Visual Analog Scale

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

    Visual Analog Scale (VAS) score ranges from 0 to 10. High scores describe more pain, and low scores describe less pain.

Secondary outcomes

  1. 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 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.

  2. The Pain Catastrophizing Scale

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

    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.

  3. Beck Depression Inventory

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

    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.

  4. Roland-Morris Disability Questionnaire

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

    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.

  5. 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.

    The Leeds Assessment of Neuropathic Symptoms and Signs is an assessment tool designed to evaluate the symptoms of neuropathic pain and the severity of these symptoms. The scale consists of 7 items, each assessing sensory changes, pain type, and the intensity of symptoms related to neuropathic pain. Scores range from a minimum of 0 to a maximum of 24. Higher scores indicate more severe neuropathic pain symptoms, while lower scores suggest milder or no neuropathic pain symptoms.

Other outcomes

  1. STarT Back Screening Tool

    Time frame: It will be evaluated in the baseline

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 2, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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