Chronic Low-back Pain (cLBP)NCT07448766
Core Muscle Training in Patients With Chronic Mechanical Low Back Pain
A study testing suspension execises, pressure biofeedback training and advices in people with Chronic Low-back Pain (cLBP), run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this study is to train core muscles in patients with chronic low back pain, the researchers will compar between the effect of suspension exercise core muscle training and pressure biofeed back core muscle training Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Chronic Low-back Pain (cLBP)
- What is being tested?
- suspension execises, pressure biofeedback training and advices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 25 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Forty-eight male and female CNLBP patients were included in this study. 2. Their age ranged from 20 to 35 years. 3. Patients complained of pain and discomfort in the lumbosacral and buttock region, lasting from 3 to 24 months.
Who cannot join
- Discogenic patients with or without radiculopathy.
- Underlying disease such as malignancy.
- Viscerogenic causes of back pain, pregnancy.
- Infection or systemic disease of musculoskeletal system.
- Sensory disturbance.
- Evidence of previous vertebral fractures or major spinal structural abnormality, spondylolysis, spondylolisthesis, ankylosing spondylitis, or sacroiliitis.
Show all 12Show fewer
- Neuromuscular diseases like multiple sclerosis or dermatologic disease that involves the lumber and abdominal area, contractures.
- History of previous back surgery or trauma.
- BMI ≥ 25 to avoid effect of obesity.
- Post menopause females to exclude post menopause hormonal changes.
- Metabolic diseases such as diabetes and hypothyroidism, coagulopathies (such as hemophilia).
- Usage of anticoagulants, febrile state; or anyone who had used coffee or tobacco 24 hours before the study evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Suspension Core Muscle Training Versus Pressure Biofeedback Training in Treatment of Chronic Mechanical Low Back Pain
The goal of this study is to train core muscles in patients with chronic low back pain, the researchers will compar between the effect of suspension exercise core muscle training and pressure biofeed back core muscle training
Read the detailed description
Recently suspension training systems have become popular as a way to improve fitness. These systems create instability during workouts which challenges the body in new ways. As a result, suspension training can help increase muscle strength mass and power. Furthermore, it enhances functional performance by engaging the core muscles more intensely. This focus on the core is important for overall fitness and can lead to better results in various physical activities. (Angleri et al., 2020), Suspension training involves using straps to hang either the lower or upper limbs allowing them to move freely. This setup creates a unique environment for exercise as it engages multiple muscle groups at once. Many exercises focus on the core which is essential for stability and strength. The movement of the limbs can introduce different challenges making workouts more dynamic and effective. Overall suspension training is a versatile method that can enhance physical fitness in various ways (Behm and Drinkwater, 2010).
Core stabilization training using pressure biofeedback has shown to be effective in reducing pain and improving function in individuals with mechanical low back pain. This type of training focuses on strengthening the muscles that support the spine. By using pressure biofeedback individuals can better understand their body's alignment and muscle engagement during exercises. As a result, many participants reported less pain both when resting and during activities. Overall, this method of training helps improve daily functioning and enhances quality of life for those suffering from low back pain. (Mahesh and Mrunmayee, 2019).
- Conditions
- Chronic Low-back Pain (cLBP)
- Being tested
- suspension execises, pressure biofeedback training, advices
- Keywords
- chronic low back pain, core muscles, pressure biofeedback training, suspension exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suspension execisesBehavioural
Participants were instructed to perform the exercises through the full range of motion using the correct technique, while maintaining a neutral alignment of the spine and pelvis throughout each movement. Each exercise was performed three times, with each repetition lasting six seconds. A three-minute rest interval was provided between exercises to ensure adequate recovery, all exercises were performed three times per week for a duration of four weeks The following exercises have been selected
- Roll-out
- Bodysaw
- Pike
- Knee-tuck
pressure biofeedback trainingBehavioural
The patients were instructed to take a relaxed breath in and out, hold the breath out, and then draw in the lower abdomen without moving the spine. Independent contraction of the transversus abdominis muscle was achieved through the abdominal drawing-in maneuver(ADIM).
- In the supine position, the pressure biofeedback unit was placed beneath the lumbar lordosis, and air was infused into the bulb to establish a baseline pressure of 40 mmHg. pressure increases of 0-2 mmHg g from a baseline of 40 mmHg
- In the prone position, the pressure biofeedback unit was positioned between the navel and the anterior superior iliac spine (ASIS), and air was infused into the bulb to establish a baseline pressure of 70 mmHg. A decrease in pressure ranging from 4 to 10 mmHg during the performance of the active drawing-in maneuverwas considered to indicate a successful execution of the exercise.
- After two weeks, lumbar stabilization exercises were progressively introduced
advicesBehavioural
- Participants are instructed to walk as normally and flexibly as possible
- Advise when lifting:
- Participants are instructed to avoid twisting and bending.
- When lifting heavy objects, they are instructed to use their thighs while keeping the back vertical.
- At other times, they are instructed to use the back and flex it appropriately.
- Participants were instructed to apply heat for 20 minutes, twice daily
- Avoid sitting or standing for prolonged period and change position every 15 minutes.
- Sitting: Sit with a back support
- Driving: Use a back support (lumbar roll) at the curve of your back.
- Participants were instructed to sleep and lie down on a firm mattress and box spring set that did not sag. If necessary, they were advised to place a board under the mattress or temporarily position the mattress on the floor.
| Study group | Role | What they receive |
|---|---|---|
| suspension training group | Active comparator | this group will recieve training of the core muscle of the low back with suspension exercises Receives: Behavioral: suspension execises |
| pressure biofeedback training group | Active comparator | This group will recieve training of core muscle of the low back with pressure biofeedback device Receives: Behavioral: pressure biofeedback training |
| control group | Placebo comparator | this group will recieve advices about low back pain Receives: Behavioral: advices |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of low back pain
Low back pain intensity will be measured using the Numeric Pain Rating Scale (NPRS). Participants will be instructed to select the number that best represents their current pain intensity. Scores range from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain severity.
Measured: one month
Change in Lumbar Extension Range of Motion
Lumbar extension range of motion will be measured using the Modified-Modified Schober Test. Measurements will be recorded in centimeters (cm).
Measured: one month
Secondary outcomes (8)
Change in Trunk Flexor Muscle Endurance
Trunk flexor muscle endurance will be assessed using the Trunk Flexor Test (TFT) from the McGill Core Endurance Test battery. Endurance time will be recorded in seconds, with longer durations indicating greater endurance.
Measured: one month
Change in Trunk Extensor Muscle Endurance
Trunk extensor muscle endurance will be evaluated using the Trunk Extensor Test (TET) from the McGill Core Endurance Test battery. Endurance time will be recorded in seconds, with longer durations reflecting better endurance.
Measured: one month
Change in Lumbar Flexion Range of Motion
Lumbar flexion range of motion will be measured using the Modified-Modified Schober Test. Measurements will be recorded in centimeters (cm).
Measured: one month
Change in Right Lateral Trunk Muscle Endurance
Right lateral trunk muscle endurance will be assessed using the Right Lateral Musculature Test from the McGill Core Endurance Test battery. Endurance time will be recorded in seconds.
Measured: one month
Change in Left Lateral Trunk Muscle Endurance
Left lateral trunk muscle endurance will be assessed using the Left Lateral Musculature Test from the McGill Core Endurance Test battery. Endurance time will be recorded in seconds.
Measured: one month
Presence of Abnormal Movement Patterns During Prone Hip Extension
Abnormal movement patterns will be assessed using the Prone Hip Extension Test. Participants will be classified as positive or negative based on the presence of any of the following:
Lumbar spine rotation
Lateral shift of the lumbar spine
Lumbar spine extension
Pelvic girdle elevation on the side of hip extension
Measured: one month
Change in Functional Disability Due to Low Back Pain
Functional disability will be assessed using the Oswestry Disability Index (ODI). The ODI consists of ten domains including pain intensity, personal care, lifting, work, sitting, standing, sleeping, sexual activity, social life, and traveling. Scores are reported as a percentage, with higher scores indicating greater disability.
Measured: one month
Change in Lumbar Core Muscle Strength
Lumbar core muscle strength will be assessed using a Pressure Biofeedback Unit (PBU). Participants will be positioned in crook-lying with the knees flexed between 70° and 90°. The PBU will be placed beneath the lumbar lordosis and inflated to a baseline pressure of 40 mmHg. Participants will be instructed to perform an abdominal drawing-in maneuver and maintain the contraction for 10 seconds. The change in pressure (mmHg) will be recorded as an indicator of lumbar core muscle activation.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 Sep 2024
- Primary completion1 Nov 2025
- Study completion25 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back Pain (cLBP)Studies of the same condition, open and under way.
- More trials run by Cairo 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
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Ramadan Abdelsatar Abo Turky, Cairo University
- Investigators
- Eman R Aboturky, MSc, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448766
- Sponsor's protocol ID
- P.T.REC/012/004184
- Status last verified
- Mar 2026
- First submitted
- 19 Feb 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: "Data from this study will not be shared to protect participant privacy and comply with ethical approvals."
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Suspension Core Muscle Training Versus Pressure Biofeedback Training in Treatment of Chronic Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT07448766
- Acronym / sponsor ID
- P.T.REC/012/004184
- Conditions
- Chronic Low-back Pain (cLBP)
- Keywords
- chronic low back pain, core muscles, pressure biofeedback training, suspension exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 4 Mar 2026 (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 goal of this study is to train core muscles in patients with chronic low back pain, the researchers will compar between the effect of suspension exercise core muscle training and pressure biofeed back core muscle training
Detailed description
Recently suspension training systems have become popular as a way to improve fitness. These systems create instability during workouts which challenges the body in new ways. As a result, suspension training can help increase muscle strength mass and power. Furthermore, it enhances functional performance by engaging the core muscles more intensely. This focus on the core is important for overall fitness and can lead to better results in various physical activities. (Angleri et al., 2020), Suspension training involves using straps to hang either the lower or upper limbs allowing them to move freely. This setup creates a unique environment for exercise as it engages multiple muscle groups at once. Many exercises focus on the core which is essential for stability and strength. The movement of the limbs can introduce different challenges making workouts more dynamic and effective. Overall suspension training is a versatile method that can enhance physical fitness in various ways (Behm and Drinkwater, 2010).
Core stabilization training using pressure biofeedback has shown to be effective in reducing pain and improving function in individuals with mechanical low back pain. This type of training focuses on strengthening the muscles that support the spine. By using pressure biofeedback individuals can better understand their body's alignment and muscle engagement during exercises. As a result, many participants reported less pain both when resting and during activities. Overall, this method of training helps improve daily functioning and enhances quality of life for those suffering from low back pain. (Mahesh and Mrunmayee, 2019).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| suspension training group | Active comparator | Behavioral: suspension execisesthis group will recieve training of the core muscle of the low back with suspension exercises |
| pressure biofeedback training group | Active comparator | Behavioral: pressure biofeedback trainingThis group will recieve training of core muscle of the low back with pressure biofeedback device |
| control group | Placebo comparator | Behavioral: advicesthis group will recieve advices about low back pain |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Forty-eight male and female CNLBP patients were included in this study. 2. Their age ranged from 20 to 35 years. 3. Patients complained of pain and discomfort in the lumbosacral and buttock region, lasting from 3 to 24 months.
Key exclusion criteria (12 listed)
- Discogenic patients with or without radiculopathy.
- Underlying disease such as malignancy.
- Viscerogenic causes of back pain, pregnancy.
- Infection or systemic disease of musculoskeletal system.
- Sensory disturbance.
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 |
|---|---|---|
| suspension execisesParticipants were instructed to perform the exercises through the full range of motion using the correct technique, while maintaining a neutral alignment of the spine and pelvis throughout each movement. Each exercise was performed three times, with each repetition lasting six seconds. A three-minute rest interval was provided between exercises to ensure adequate recovery, all exercises were performed three times per week for a duration of four weeks The following exercises have been selected 1. Roll-out 2. Bodysaw 3. Pike 4. Knee-tuck | Behavioural | suspension training group |
| pressure biofeedback trainingThe patients were instructed to take a relaxed breath in and out, hold the breath out, and then draw in the lower abdomen without moving the spine. Independent contraction of the transversus abdominis muscle was achieved through the abdominal drawing-in maneuver(ADIM). * In the supine position, the pressure biofeedback unit was placed beneath the lumbar lordosis, and air was infused into the bulb to establish a baseline pressure of 40 mmHg. pressure increases of 0-2 mmHg g from a baseline of 40 mmHg * In the prone position, the pressure biofeedback unit was positioned between the navel and the anterior superior iliac spine (ASIS), and air was infused into the bulb to establish a baseline pressure of 70 mmHg. A decrease in pressure ranging from 4 to 10 mmHg during the performance of the active drawing-in maneuverwas considered to indicate a successful execution of the exercise. * After two weeks, lumbar stabilization exercises were progressively introduced | Behavioural | pressure biofeedback training group |
| advices1. Participants are instructed to walk as normally and flexibly as possible 2. Advise when lifting: * Participants are instructed to avoid twisting and bending. * When lifting heavy objects, they are instructed to use their thighs while keeping the back vertical. * At other times, they are instructed to use the back and flex it appropriately. 3. Participants were instructed to apply heat for 20 minutes, twice daily 4. Avoid sitting or standing for prolonged period and change position every 15 minutes. 5. Sitting: Sit with a back support 6. Driving: Use a back support (lumbar roll) at the curve of your back. 7. Participants were instructed to sleep and lie down on a firm mattress and box spring set that did not sag. If necessary, they were advised to place a board under the mattress or temporarily position the mattress on the floor. | Behavioural | control group |
Primary outcome
change of low back pain
Time frame: one month
Low back pain intensity will be measured using the Numeric Pain Rating Scale (NPRS). Participants will be instructed to select the number that best represents their current pain intensity. Scores range from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain severity.
Change in Lumbar Extension Range of Motion
Time frame: one month
Lumbar extension range of motion will be measured using the Modified-Modified Schober Test. Measurements will be recorded in centimeters (cm).
8 secondary outcomes
Change in Trunk Flexor Muscle Endurance
Time frame: one month
Change in Trunk Extensor Muscle Endurance
Time frame: one month
Change in Lumbar Flexion Range of Motion
Time frame: one month
Change in Right Lateral Trunk Muscle Endurance
Time frame: one month
Change in Left Lateral Trunk Muscle Endurance
Time frame: one month
Presence of Abnormal Movement Patterns During Prone Hip Extension
Time frame: one month
Change in Functional Disability Due to Low Back Pain
Time frame: one month
Change in Lumbar Core Muscle Strength
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No. "Data from this study will not be shared to protect participant privacy and comply with ethical approvals."
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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. This study is not recruiting at the moment.
Eman R Aboturky, MSc principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing suspension execises, pressure biofeedback training and advices in people with Chronic Low-back Pain (cLBP), run by Cairo University at 1 site in Egypt.
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 1 inclusion and 12 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: finished, as of the sponsor's last update on 21 Oct 2026. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of low back pain (time frame: one month). The study lists 2 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 21 Oct 2026.