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

A

Abant Izzet Baysal University

Status

Enrolling

Conditions

Chronic Non-specific Low Back Pain

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06856642
AIBU-FTR-SK-09

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Real-Time Ultrasound Biofeedback with Abdominal Draw-In Manuever
Active Comparator group
Treatment:
Other: Real-Time Ultrasound Biofeedback with Abdominal Draw-In Manuever
Other: Conservative Physical Therapy
Conservative treatment group without biofeedback
Active Comparator group
Treatment:
Other: Conservative Physical Therapy
Other: Abdominal Draw-in Manuever

Trial contacts and locations

1

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Central trial contact

Serdar KILINÇ

Data sourced from clinicaltrials.gov

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