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Completed

NCT Number: NCT07448766

Core Muscle Training in Patients With 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

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Key information

Conditions

Chronic Low-back Pain (cLBP)

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy

Cairo, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

suspension execises

Behavioral

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 training

Behavioral

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

advices

Behavioral
  • 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.

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. Change in Lumbar Flexion Range of Motion

    Time frame: one month

    Lumbar flexion range of motion will be measured using the Modified-Modified Schober Test. Measurements will be recorded in centimeters (cm).

  2. Change in Trunk Flexor Muscle Endurance

    Time frame: one month

    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.

  3. Change in Trunk Extensor Muscle Endurance

    Time frame: one month

    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.

  4. Change in Right Lateral Trunk Muscle Endurance

    Time frame: one month

    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.

  5. Change in Left Lateral Trunk Muscle Endurance

    Time frame: one month

    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.

  6. Presence of Abnormal Movement Patterns During Prone Hip Extension

    Time frame: one month

    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

  7. Change in Functional Disability Due to Low Back Pain

    Time frame: one month

    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.

  8. Change in Lumbar Core Muscle Strength

    Time frame: one month

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Suspension Core Muscle Training Versus Pressure Biofeedback Training in Treatment of Chronic Mechanical Low Back Pain

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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