Chronic Non-specific Low Back PainNCT06856642
Comparison of Abdominal Draw-in Maneuver With Real-time Ultrasound Imaging Biofeedback vs Conservative Physical Therapy in Patients With Chronic Low Back Pain
A study testing Conservative Physical Therapy, Abdominal Draw-in Manuever and Real-Time Ultrasound Biofeedback with Abdominal Draw-In Manuever in people with Chronic Non-specific Low Back Pain, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Non-specific Low Back Pain
- What is being tested?
- Conservative Physical Therapy, Abdominal Draw-in Manuever and Real-Time Ultrasound Biofeedback with Abdominal Draw-In Manuever
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Neurological diseases such as Parkinson's or Multiple Sclerosis.
- Systemic diseases that prevent exercise.
- Patients with a Mini-Mental Test score below 24.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Abant Izzet Baysal University
Bolu, 14100
Serdar KILINÇ, +90 5055913181, drserdarkilinc@hotmail.com
About this study
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
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.
Read the 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
- Being tested
- Conservative Physical Therapy, Abdominal Draw-in Manuever, Real-Time Ultrasound Biofeedback with Abdominal Draw-In Manuever
- Keywords
- chronic non-specific low back pain, low back pain, ultrasound imaging, real-time ultrasound biofeedback, biofeedback, abdominal draw-in manuever
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative Physical TherapyOther
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 ManueverOther
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.
Real-Time Ultrasound Biofeedback with Abdominal Draw-In ManueverOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Real-Time Ultrasound Biofeedback with Abdominal Draw-In Manuever | Active comparator | Not described Receives: Other: Conservative Physical Therapy; Other: Real-Time Ultrasound Biofeedback with Abdominal Draw-In Manuever |
| Conservative treatment group without biofeedback | Active comparator | Not described Receives: Other: Conservative Physical Therapy; Other: Abdominal Draw-in Manuever |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: In the 3rd week of treatment
Secondary outcomes (8)
Berg Balance Scale
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.
Measured: before treatment
Berg Balance Scale
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.
Measured: In the 3rd week of treatment
Oswestry Disability Index
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.
Measured: before treatment
Oswestry Disability Index
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.
Measured: In the 3rd week of treatment
Lomber Range of Motion
The range of motion of lomber region will be measured passively with a goniometer in the flexion, abduction, internal rotation and external rotation directions.
Measured: before treatment
Lomber Range of Motion
The range of motion of lomber region will be measured passively with a goniometer in the flexion, abduction, internal rotation and external rotation directions.
Measured: In the 3rd week of treatment
EQ-5D-3L General Quality of Life Scale
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).
Measured: before treatment
EQ-5D-3L General Quality of Life Scale
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).
Measured: In the 3rd week of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start1 Mar 2025 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non-specific Low Back PainStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serdar Kilinc, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856642
- Sponsor's protocol ID
- AIBU-FTR-SK-09
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06856642
- Acronym / sponsor ID
- AIBU-FTR-SK-09
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- Neuropathic pain complaints.
- Pregnancy status.
- History of infection, cancer, or trauma.
- Neurological abnormalities.
- History of lumbar spine surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conservative Physical TherapyTranscutaneous 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 | Other | Conservative treatment group without biofeedback, Real-Time Ultrasound Biofeedback with Abdominal Draw-In Manuever |
| Abdominal Draw-in ManueverStarting 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. | Other | Conservative treatment group without biofeedback |
| Real-Time Ultrasound Biofeedback with Abdominal Draw-In ManueverThe 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. | Other | Real-Time Ultrasound Biofeedback with Abdominal Draw-In Manuever |
Primary outcome
Visual Analogue Scale
Time frame: before treatment
Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
Visual Analogue Scale
Time frame: 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
Time frame: before 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.
Muscle Thickness
Time frame: 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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative Physical Therapy, Abdominal Draw-in Manuever and Real-Time Ultrasound Biofeedback with Abdominal Draw-In Manuever in people with Chronic Non-specific Low Back Pain, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Serdar KILINÇ (+90 5055913181, drserdarkilinc@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: before treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.