Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:39 AM
Study NCT ID:
NCT07448766
Status:
COMPLETED
Last Update Posted:
2026-03-04
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Core Muscle Training in Patients With Chronic Mechanical Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-12-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-01', 'studyFirstSubmitDate': '2026-02-19', 'studyFirstSubmitQcDate': '2026-03-01', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of low back pain', 'timeFrame': 'one month', 'description': '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.'}, {'measure': 'Change in Lumbar Extension Range of Motion', 'timeFrame': 'one month', 'description': 'Lumbar extension range of motion will be measured using the Modified-Modified Schober Test. Measurements will be recorded in centimeters (cm).'}], 'secondaryOutcomes': [{'measure': 'Change in Lumbar Flexion Range of Motion', 'timeFrame': 'one month', 'description': 'Lumbar flexion range of motion will be measured using the Modified-Modified Schober Test. Measurements will be recorded in centimeters (cm).'}, {'measure': 'Change in Trunk Flexor Muscle Endurance', 'timeFrame': 'one month', 'description': '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.'}, {'measure': 'Change in Trunk Extensor Muscle Endurance', 'timeFrame': 'one month', 'description': '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.'}, {'measure': 'Change in Right Lateral Trunk Muscle Endurance', 'timeFrame': 'one month', 'description': '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.'}, {'measure': 'Change in Left Lateral Trunk Muscle Endurance', 'timeFrame': 'one month', 'description': '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.'}, {'measure': 'Presence of Abnormal Movement Patterns During Prone Hip Extension', 'timeFrame': 'one month', 'description': '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:\n\nLumbar spine rotation\n\nLateral shift of the lumbar spine\n\nLumbar spine extension\n\nPelvic girdle elevation on the side of hip extension'}, {'measure': 'Change in Functional Disability Due to Low Back Pain', 'timeFrame': 'one month', 'description': '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.'}, {'measure': 'Change in Lumbar Core Muscle Strength', 'timeFrame': 'one month', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic low back pain', 'core muscles', 'pressure biofeedback training', 'suspension exercises'], 'conditions': ['Chronic Low-back Pain (cLBP)']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': "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).\n\nCore 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n1. Discogenic patients with or without radiculopathy.\n2. Underlying disease such as malignancy.\n3. Viscerogenic causes of back pain, pregnancy.\n4. Infection or systemic disease of musculoskeletal system.\n5. Sensory disturbance.\n6. Evidence of previous vertebral fractures or major spinal structural abnormality, spondylolysis, spondylolisthesis, ankylosing spondylitis, or sacroiliitis.\n7. Neuromuscular diseases like multiple sclerosis or dermatologic disease that involves the lumber and abdominal area, contractures.\n8. History of previous back surgery or trauma.\n9. BMI ≥ 25 to avoid effect of obesity.\n10. Post menopause females to exclude post menopause hormonal changes.\n11. Metabolic diseases such as diabetes and hypothyroidism, coagulopathies (such as hemophilia).\n12. Usage of anticoagulants, febrile state; or anyone who had used coffee or tobacco 24 hours before the study evaluation.'}, 'identificationModule': {'nctId': 'NCT07448766', 'briefTitle': 'Core Muscle Training in Patients With Chronic Mechanical Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Suspension Core Muscle Training Versus Pressure Biofeedback Training in Treatment of Chronic Mechanical Low Back Pain', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004184'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'suspension training group', 'description': 'this group will recieve training of the core muscle of the low back with suspension exercises', 'interventionNames': ['Behavioral: suspension execises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pressure biofeedback training group', 'description': 'This group will recieve training of core muscle of the low back with pressure biofeedback device', 'interventionNames': ['Behavioral: pressure biofeedback training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'this group will recieve advices about low back pain', 'interventionNames': ['Behavioral: advices']}], 'interventions': [{'name': 'suspension execises', 'type': 'BEHAVIORAL', 'description': '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\n\n1. Roll-out\n2. Bodysaw\n3. Pike\n4. Knee-tuck', 'armGroupLabels': ['suspension training group']}, {'name': 'pressure biofeedback training', 'type': 'BEHAVIORAL', 'description': '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).\n\n* 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\n* 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.\n* After two weeks, lumbar stabilization exercises were progressively introduced', 'armGroupLabels': ['pressure biofeedback training group']}, {'name': 'advices', 'type': 'BEHAVIORAL', 'description': '1. Participants are instructed to walk as normally and flexibly as possible\n2. Advise when lifting:\n\n * Participants are instructed to avoid twisting and bending.\n * When lifting heavy objects, they are instructed to use their thighs while keeping the back vertical.\n * At other times, they are instructed to use the back and flex it appropriately.\n3. Participants were instructed to apply heat for 20 minutes, twice daily\n4. Avoid sitting or standing for prolonged period and change position every 15 minutes.\n5. Sitting: Sit with a back support\n6. Driving: Use a back support (lumbar roll) at the curve of your back.\n7. 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.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Physical Therapy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Eman R Aboturky, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '"Data from this study will not be shared to protect participant privacy and comply with ethical approvals."'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer at orthopedic department, faculty of physical therapy', 'investigatorFullName': 'Eman Ramadan Abdelsatar Abo Turky', 'investigatorAffiliation': 'Cairo University'}}}}