- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07448766
Core Muscle Training in Patients With Chronic Mechanical Low Back Pain
Effect of Suspension Core Muscle Training Versus Pressure Biofeedback Training in Treatment of Chronic Mechanical Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt
- Faculty of Physical Therapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: suspension training group
this group will recieve training of the core muscle of the low back with suspension exercises
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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
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Active Comparator: pressure biofeedback training group
This group will recieve training of core muscle of the low back with pressure biofeedback device
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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).
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Placebo Comparator: control group
this group will recieve advices about low back pain
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change of low back pain
Time Frame: one month
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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.
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one month
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Change in Lumbar Extension Range of Motion
Time Frame: one month
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Lumbar extension range of motion will be measured using the Modified-Modified Schober Test.
Measurements will be recorded in centimeters (cm).
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one month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Lumbar Flexion Range of Motion
Time Frame: one month
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Lumbar flexion range of motion will be measured using the Modified-Modified Schober Test.
Measurements will be recorded in centimeters (cm).
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one month
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Change in Trunk Flexor Muscle Endurance
Time Frame: one month
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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.
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one month
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Change in Trunk Extensor Muscle Endurance
Time Frame: one month
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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.
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one month
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Change in Right Lateral Trunk Muscle Endurance
Time Frame: one month
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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.
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one month
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Change in Left Lateral Trunk Muscle Endurance
Time Frame: one month
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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.
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one month
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Presence of Abnormal Movement Patterns During Prone Hip Extension
Time Frame: one month
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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 |
one month
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Change in Functional Disability Due to Low Back Pain
Time Frame: one month
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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.
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one month
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Change in Lumbar Core Muscle Strength
Time Frame: one month
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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.
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one month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eman R Aboturky, MSc, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/004184
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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