Lumbopelvic Stabilization Versus Pilates Exercises On Gait Phases And Peak Pressure On Foot In Low Back Pain (LBP)
Primary Purpose
Low Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
lumbopelvic stabilization exercises
pilates exercise
conventional therapy
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring lumbopelvaic stabilization exercise, pilates exercise, gait cycle phases, peak pressure
Eligibility Criteria
Inclusion Criteria:
- Their age between 20 and 40 years
- patients is required to have chronic nonspecific LBP (more than12 weeks), defined as Pain in the lumbar and/or buttock region (defined as pain reported below the level of T12 and no lower than the buttock line).
- Patients will be excluded if they have signs of serious spinal pathology (red flags) including significant trauma, unexplained weight loss, and widespread neurologic changes
Exclusion Criteria:
- subjects with specific back pain (fracture, osteoporosis or degenerative changes, prolapse intervertebral disc, bone disorders, arthritis, tumour),
- subjects with neurological involvement (radiculopathy, myelopathy),
- subjects with previous spinal surgery
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
lumbopelvic stabilization exercises
Pilates exercises
conventional therapy
Arm Description
the patients will receive trunk stabilization exercise +strengthening exercises for the abdominal, back, and hip muscles three times/ week for three months
the patients will receive trunk pilates exercise +strengthening exercises for the abdominal, back, and hip muscles three times/ week for three months
the patients will receive trunk stabilization exercise three times/ week for three months
Outcomes
Primary Outcome Measures
gait cycle phases and maximum peak pressure on foot
gait cycle phases and peak pressure will be measure by Tekscan walkway
Secondary Outcome Measures
pain intensity
visual analogue scale will be used for measuring pain level
disability
Functional disability of each patient was assessed by Modified Oswestry Disability Questionnaire
muscle endurance
Sorensen test (low back fatigue test) and Trunk flexion endurance test will be used for measuring the level of endurance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04942782
Brief Title
Lumbopelvic Stabilization Versus Pilates Exercises On Gait Phases And Peak Pressure On Foot In Low Back Pain
Acronym
LBP
Official Title
Lumbopelvic Stabilization Versus Pilates Exercises On Gait Cycle Phases And Maximum Peak Pressure On Foot In Chronic Nonspecific Low Back Pain: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Anticipated)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
August 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
the purpose of this trial is to investigate and compare between lumbopelvic stabilization and pilates exercises on gait cycle phases and maximum peak pressure on the foot in chronic nonspecific low back pain?
Detailed Description
LBP is the leading cause of activity limitation, results in significant losses in productivity at work, and incurs billions of dollars in medical expenditure annually So, the aim of physical therapy treatment in the patient with chronic nonspecific low back pain is more effective in improving gait cycle phases and maximum peak pressure on the foot and help LBP patients to walk normally as much as possible, also this will improve our body of knowledge about the best modalities for treating LBP. The finding of this study may help LBP patients avoid exposure to complications due to altered gait cycle phases and maximum peak pressure on the foot. Also, it will help physiotherapists to know which treatment will be effective in improving gait cycle phases and maximum peak pressure on the foot. one hundred patients with mechanical low back pain will be allocated randomly to three groups; group A will receive pilates, group B will receive lumbopelvic stabilization exercise and group C will receive strengthening exercises for the abdominals, back, and hip muscles
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
lumbopelvaic stabilization exercise, pilates exercise, gait cycle phases, peak pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
lumbopelvic stabilization and Pilates
Masking
ParticipantOutcomes Assessor
Masking Description
random generator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lumbopelvic stabilization exercises
Arm Type
Experimental
Arm Description
the patients will receive trunk stabilization exercise +strengthening exercises for the abdominal, back, and hip muscles three times/ week for three months
Arm Title
Pilates exercises
Arm Type
Experimental
Arm Description
the patients will receive trunk pilates exercise +strengthening exercises for the abdominal, back, and hip muscles three times/ week for three months
Arm Title
conventional therapy
Arm Type
Active Comparator
Arm Description
the patients will receive trunk stabilization exercise three times/ week for three months
Intervention Type
Other
Intervention Name(s)
lumbopelvic stabilization exercises
Intervention Description
the patients will receive lumbopelvic stabilization in the form of three parts: 1 Segmental control over primary stabilizers (mainly TrA, deep multifidus, pelvic floor and diaphragm) 2-Exercises in closed chain, with low velocity and low load 3-Exercises in open chain, with high velocity and load
Intervention Type
Other
Intervention Name(s)
pilates exercise
Intervention Description
the patient will receive pilates exercise in the form of Breast stroke prep, Side leg lift series, One leg circle, Hundreds, Shoulder bridge, and Spine stretch forward
Intervention Type
Other
Intervention Name(s)
conventional therapy
Intervention Description
Patients will received strengthening exercises for the abdominal, back, and hip muscles. The patients performed an average of three series of ten repetitions of each exercise. Increases in the number of exercises performed in each session (or load progression) occurred according to individual tolerance
Primary Outcome Measure Information:
Title
gait cycle phases and maximum peak pressure on foot
Description
gait cycle phases and peak pressure will be measure by Tekscan walkway
Time Frame
up to twelve weeks
Secondary Outcome Measure Information:
Title
pain intensity
Description
visual analogue scale will be used for measuring pain level
Time Frame
up to twelve weeks
Title
disability
Description
Functional disability of each patient was assessed by Modified Oswestry Disability Questionnaire
Time Frame
up to twelve weeks
Title
muscle endurance
Description
Sorensen test (low back fatigue test) and Trunk flexion endurance test will be used for measuring the level of endurance
Time Frame
up to twelve weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Their age between 20 and 40 years
patients is required to have chronic nonspecific LBP (more than12 weeks), defined as Pain in the lumbar and/or buttock region (defined as pain reported below the level of T12 and no lower than the buttock line).
Patients will be excluded if they have signs of serious spinal pathology (red flags) including significant trauma, unexplained weight loss, and widespread neurologic changes
Exclusion Criteria:
subjects with specific back pain (fracture, osteoporosis or degenerative changes, prolapse intervertebral disc, bone disorders, arthritis, tumour),
subjects with neurological involvement (radiculopathy, myelopathy),
subjects with previous spinal surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
al shaymaa sh abd el azeim, lecturer
Phone
01033771553
Email
alshaymaa.shaaban@pt.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
al shaymaa sh abd el azeim, lecturer
Phone
01033771553
Email
alshaymaa.ahaaban@pt.cu.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Lumbopelvic Stabilization Versus Pilates Exercises On Gait Phases And Peak Pressure On Foot In Low Back Pain
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