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

NCT ID: NCT06856642

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-02-28

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.

Conditions

Chronic Non-specific Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Real-Time Ultrasound Biofeedback with Abdominal Draw-In Manuever

Group Type: ACTIVE_COMPARATOR

Conservative Physical Therapy

Intervention Type: OTHER

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.The packs, which are kept in hydrocollator tanks, will be applied at a temperature that will not harm the patient.The application time is 20 minutes.

Therapeutic Ultrasound:This method, which uses sound waves to support tissue healing, creates heating and healing effects in deep tissues and is commonly used to reduce pain and relieve muscle spasmsThe frequency of the applied ultrasound will be 1 MHz, with an intensity of 1.5 W/cm², and it will be applied for 8 minutes in continuous mode

Real-Time Ultrasound Biofeedback with Abdominal Draw-In Manuever

Intervention Type: OTHER

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. During the exercise, the patient's muscle is displayed on the screen, and they are asked to hold the contraction at its maximum level for 10 seconds. After the contraction phase, the patient is instructed to relax and rest for 2 minutes. The treatment is completed with a total of 10 repetitions.

Conservative treatment group without biofeedback

Group Type: ACTIVE_COMPARATOR

Conservative Physical Therapy

Intervention Type: OTHER

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.The packs, which are kept in hydrocollator tanks, will be applied at a temperature that will not harm the patient.The application time is 20 minutes.

Therapeutic Ultrasound:This method, which uses sound waves to support tissue healing, creates heating and healing effects in deep tissues and is commonly used to reduce pain and relieve muscle spasmsThe frequency of the applied ultrasound will be 1 MHz, with an intensity of 1.5 W/cm², and it will be applied for 8 minutes in continuous mode

Abdominal Draw-in Manuever

Intervention Type: OTHER

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 contracting the hip muscles. The goal is to activate only the deep abdominal muscles. Checking for Proper Muscle Activation: The patient can place their fingertips on the lower abdominal region (just above the pelvic bone) to feel whether the transversus abdominis muscle is activating correctly. Maintaining the Position: The patient holds this activation for 5-10 seconds while continuing to breathe naturally, then relaxes. Muscles should be fully relaxed between repetitions.

Interventions

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.The packs, which are kept in hydrocollator tanks, will be applied at a temperature that will not harm the patient.The application time is 20 minutes.

Therapeutic Ultrasound:This method, which uses sound waves to support tissue healing, creates heating and healing effects in deep tissues and is commonly used to reduce pain and relieve muscle spasmsThe frequency of the applied ultrasound will be 1 MHz, with an intensity of 1.5 W/cm², and it will be applied for 8 minutes in continuous mode

Intervention Type: 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 contracting the hip muscles. The goal is to activate only the deep abdominal muscles. Checking for Proper Muscle Activation: The patient can place their fingertips on the lower abdominal region (just above the pelvic bone) to feel whether the transversus abdominis muscle is activating correctly. Maintaining the Position: The patient holds this activation for 5-10 seconds while continuing to breathe naturally, then relaxes. Muscles should be fully relaxed between repetitions.

Intervention Type: 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. During the exercise, the patient's muscle is displayed on the screen, and they are asked to hold the contraction at its maximum level for 10 seconds. After the contraction phase, the patient is instructed to relax and rest for 2 minutes. The treatment is completed with a total of 10 repetitions.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Serdar Kilinc

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Abant Izzet Baysal University

Bolu, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Serdar KILINÇ

Role: CONTACT

drserdarkilinc@hotmail.com

+90 5055913181

Facility Contacts

Serdar KILINÇ

Role: primary

drserdarkilinc@hotmail.com

+90 5055913181

Other Identifiers

AIBU-FTR-SK-09

Identifier Type: -

Identifier Source: org_study_id