Comparison of Abdominal Draw-in Maneuver With Real-time Ultrasound Imaging Biofeedback vs Conservative Physical Therapy in Patients With Chronic Low Back Pain
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: Conservative Physical Therapy, Abdominal Draw-in Manuever, Real-Time Ultrasound Biofeedback with Abdominal Draw-In Manuever.
- Who it may be relevant to
- Registry conditions: Chronic Non-specific Low Back Pain. 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
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
Overview
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.
Interventions
- Other Conservative Physical Therapy
Transcutaneous Electrical Nerve Stimulation (TENS):It is an electrotherapy modality commonly used in pain management. Conventional TENS will be applied to our patients. The frequency of Conventional TENS will be 50 Hz, the pulse duration will be 80 µs, the amplitude will be of mild to moderate intensity as perceived by the patient, and the duration will be 20 minutes. Hot Pack:It is a superficial heat therapy method commonly used to reduce muscle spasms, increase circulation, and alleviate pain - Other Abdominal Draw-in Manuever
Starting Position: The patient lies in a supine position with knees bent and feet flat on the ground. The neck and spine are kept in a neutral position. Breath Control: The patient focuses on abdominal expansion while inhaling and flattening the abdomen while exhaling. Transversus Abdominis Activation: The patient attempts to draw the abdominal muscles inward (pulling the navel toward the spine). During this movement, care should be taken to avoid pressing the lower back against the ground or co - Other Real-Time Ultrasound Biofeedback with Abdominal Draw-In Manuever
The patient, who has been instructed on the abdominal drawing-in exercise, assumes a supine position with knees bent. The ultrasound screen is positioned so that both the practitioner and the patient can see it. The researcher places the linear ultrasound probe on the patient's transversus abdominis muscle to obtain an image, which is then shown to the patient for awareness. The patient is instructed to keep their eyes on the screen and follow their muscle activity throughout the exercise. Durin
Primary outcome measures
- Visual Analogue Scale [Time frame: before treatment]
- Visual Analogue Scale [Time frame: In the 3rd week of treatment]
- Muscle Thickness [Time frame: before treatment]
- Muscle Thickness [Time frame: In the 3rd week of treatment]
Secondary outcome measures (8)
- Berg Balance Scale [Time frame: before treatment]
- Berg Balance Scale [Time frame: In the 3rd week of treatment]
- Oswestry Disability Index [Time frame: before treatment]
- Oswestry Disability Index [Time frame: In the 3rd week of treatment]
- Lomber Range of Motion [Time frame: before treatment]
- Lomber Range of Motion [Time frame: In the 3rd week of treatment]
- EQ-5D-3L General Quality of Life Scale [Time frame: before treatment]
- EQ-5D-3L General Quality of Life Scale [Time frame: In the 3rd week of treatment]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Abant Izzet Baysal University — Bolu
Identifiers
NCT: NCT06856642 · AIBU-FTR-SK-09