Clinical trial NCT06856642: Comparison of Abdominal Draw-in Maneuver With Real-time Ultrasound Imaging Biofeedback vs Conservative Physical Therapy in Patients With Chronic Low Back Pain
Official title: Comparison of Abdominal Draw-in Maneuver With Real-time Ultrasound Imaging Biofeedback vs Conservative Physical Therapy in Patients With Chronic Low Back Pain: A Prospective, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Non-specific Low Back Pain
Keywords: chronic non-specific low back pain
low back pain
ultrasound imaging
real-time ultrasound biofeedback
biofeedback
abdominal draw-in manuever
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effectiveness of abdominal drawing-in maneuver with real-time ultrasound biofeedback to conservative treatment in patients with chronic nonspecific low back pain.

Detailed description: Low back pain is a common clinical condition among musculoskeletal disorders. It can be classified into two main categories: acute and chronic. Acute low back pain is usually limited to a duration of 6 weeks or less, whereas chronic low back pain refers to pain lasting 12 weeks or longer. Chronic low back pain is characterized by persistent and untreated pain, which can significantly affect individuals' physical and psychological health. A multidisciplinary approach is required for its treatment. Physical therapy, pharmacological approaches, psychotherapy, and exercise are the main treatment methods.

Exercise plays an active role in both the prevention and treatment of the disease. Among many exercise methods, the abdominal drawing-in maneuver has been proven effective in the literature. Biofeedback is a technique that helps individuals consciously control their physiological processes. Real-time ultrasound biofeedback stands out as a technique that directly visualizes musculoskeletal system functions. This method uses high-frequency sound waves to assess the dynamic movements of internal organs and muscle structures. Through this technology, individuals can visualize their movements in real time and consciously adjust their muscle activity or posture. It offers significant advantages, particularly in clinical and sports applications such as pelvic floor rehabilitation, postural balance training, and motor control skill development.

The aim of our study is to compare the effectiveness of exercises performed with real-time ultrasound biofeedback with those in patients receiving conservative treatment. Patients will be randomly assigned to two groups: Group 1: Patients receiving conservative treatment and performing the abdominal drawing-in maneuver with real-time ultrasound imaging biofeedback. Group 2 (Control Group): Patients receiving conservative treatment and performing the abdominal drawing-in maneuver with only verbal instruction. A total of 40 patients are planned to be included in the study.

Eligibility criteria: Inclusion Criteria:

* The duration of low back pain is at least 3 months.
* Low back pain with or without radiation to the lower extremities.
* Age between 18-65 years.
* Chronic nonspecific low back pain patients.

Exclusion Criteria:

* Neuropathic pain complaints.
* Pregnancy status.
* History of infection, cancer, or trauma.
* Neurological abnormalities.
* History of lumbar spine surgery.
* History of conservative physical therapy and/or injections in the lumbar region within the last 6 months.
* Neurological diseases such as Parkinson's or Multiple Sclerosis.
* Systemic diseases that prevent exercise.
* Patients with a Mini-Mental Test score below 24.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: before treatment
measure: Visual Analogue Scale
timeFrame: In the 3rd week of treatment
measure: Muscle Thickness
timeFrame: before treatment
measure: Muscle Thickness
timeFrame: In the 3rd week of treatment
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: before treatment
measure: Berg Balance Scale
timeFrame: In the 3rd week of treatment
measure: Oswestry Disability Index
timeFrame: before treatment
measure: Oswestry Disability Index
timeFrame: In the 3rd week of treatment
measure: Lomber Range of Motion
timeFrame: before treatment
measure: Lomber Range of Motion
timeFrame: In the 3rd week of treatment
measure: EQ-5D-3L General Quality of Life Scale
timeFrame: before treatment
measure: EQ-5D-3L General Quality of Life Scale
timeFrame: In the 3rd week of treatment
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University
Study officials:
References: