Comparison of Abdominal Draw-in Maneuver With Real-time Ultrasound Imaging Biofeedback vs Conservative Physical Therapy in Patients With Chronic Low Back Pain

Not Applicable

Recruiting

• Conditions: Chronic Non-specific Low Back Pain

• Registration Number: NCT06856642
• Lead Sponsor: Abant Izzet Baysal University

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.

Study Timeline

• Study First Submitted: 2025-02-27
• Study First Submitted QC: 2025-02-27
• Status Verified: 2025-03
• Study Start: 2025-03-01
• Study First Posted: 2025-03-04
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-06
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	In the 3rd week of treatment	Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
Muscle Thickness	In the 3rd week of treatment	The linear probe is placed transversely at the point where the iliac crest intersects with the middle point of the T12 rib, crossing the mid-axillary line. The position of the linear probe is adjusted until all abdominal muscles are visible. To standardize the images, the center point of the probe in the image is shifted 2 cm laterally to align with the insertion of the superficial fascia of the transversus abdominis muscle. The thickness of the transversus abdominis muscle is determined by the distance between the superficial and deep fascia at the thickest point in the image. The thickness between the two fasciae is measured using the digital caliper of the device.

Secondary Outcome Measures

Name	Time	Method
Berg Balance Scale	In the 3rd week of treatment	The Berg Balance Scale is an assessment tool developed to measure balance performance in geriatric patients. It is frequently used in clinical studies to evaluate postural control and predict fall risk. The scale consists of 14 instructions, and the patient's performance for each instruction is observed and scored from 0 to 4. A score of 0 is given when the patient is unable to perform the activity at all, while a score of 4 is given when the patient completes the activity independently.
Oswestry Disability Index	In the 3rd week of treatment	The Oswestry Disability Index is a specific questionnaire method used to assess functional status in patients with low back pain. It consists of 10 items, each evaluating the impact of low back pain on daily living activities. Each item is rated from 0 to 5, and the total score is converted into a percentage for evaluation. A total score of 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippled condition, and 81-100%: Complete disability.
Lomber Range of Motion	In the 3rd week of treatment	The range of motion of lomber region will be measured passively with a goniometer in the flexion, abduction, internal rotation and external rotation directions.
EQ-5D-3L General Quality of Life Scale	In the 3rd week of treatment	The EQ-5D-3L is a standardized, simple, and short questionnaire method used to measure individuals' overall health status. It contains five questions: mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. For each question, a 3-level assessment is made (1: No problems, 2: Moderate problems, 3: Severe problems).

Trial Locations

Locations (1)

Abant Izzet Baysal University; 🇹🇷 Bolu, Turkey