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

NCT06856642 | Recruiting

• 1 other identifier: AIBU-FTR-SK-09
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• Visual Analogue Scale

  Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).

  before treatment

• Visual Analogue Scale

  Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).

  In the 3rd week of treatment

• Muscle Thickness

  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.

  before treatment

• Muscle Thickness

  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.

  In the 3rd week of treatment

Secondary Outcomes (8)

• Berg Balance Scale

  before treatment

• Berg Balance Scale

  In the 3rd week of treatment

• Oswestry Disability Index

  before treatment

• Oswestry Disability Index

  In the 3rd week of treatment

• Lomber Range of Motion

  before treatment

Study Arms (2)

Real-Time Ultrasound Biofeedback with Abdominal Draw-In Manuever

ACTIVE COMPARATOR

Other: Conservative Physical Therapy; Other: Real-Time Ultrasound Biofeedback with Abdominal Draw-In Manuever

Conservative treatment group without biofeedback

ACTIVE COMPARATOR

Other: Conservative Physical Therapy; Other: Abdominal Draw-in Manuever

Interventions

Conservative Physical Therapy 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

Conservative treatment group without biofeedback; Real-Time Ultrasound Biofeedback with Abdominal Draw-In Manuever

Abdominal Draw-in Manuever 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.

Conservative treatment group without biofeedback

Real-Time Ultrasound Biofeedback with Abdominal Draw-In Manuever 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.

Real-Time Ultrasound Biofeedback with Abdominal Draw-In Manuever

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Abant Izzet Baysal University

Bolu, 14100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Serdar KILINÇ

CONTACT

+90 5055913181; drserdarkilinc@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 4, 2025
• Study Start: March 1, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

TU (1)