Low Back PainLBPNCT04942782
Lumbopelvic Stabilization Versus Pilates Exercises On Gait Phases And Peak Pressure On Foot In Low Back Pain
A study testing lumbopelvic stabilization exercises, pilates exercise and conventional therapy in people with Low Back Pain, run by Cairo University.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- lumbopelvic stabilization exercises, pilates exercise and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 1 Aug 2021
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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?
Read the 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
- Conditions
- Low Back Pain
- Being tested
- lumbopelvic stabilization exercises, pilates exercise, conventional therapy
- Keywords
- lumbopelvaic stabilization exercise, pilates exercise, gait cycle phases, peak pressure
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbopelvic stabilization exercisesOther
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
pilates exerciseOther
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
conventional therapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| lumbopelvic stabilization exercises | Experimental | the patients will receive trunk stabilization exercise +strengthening exercises for the abdominal, back, and hip muscles three times/ week for three months Receives: Other: lumbopelvic stabilization exercises; Other: conventional therapy |
| Pilates exercises | Experimental | the patients will receive trunk pilates exercise +strengthening exercises for the abdominal, back, and hip muscles three times/ week for three months Receives: Other: pilates exercise; Other: conventional therapy |
| conventional therapy | Active comparator | the patients will receive trunk stabilization exercise three times/ week for three months Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
gait cycle phases and maximum peak pressure on foot
gait cycle phases and peak pressure will be measure by Tekscan walkway
Measured: up to twelve weeks
Secondary outcomes (3)
pain intensity
visual analogue scale will be used for measuring pain level
Measured: up to twelve weeks
disability
Functional disability of each patient was assessed by Modified Oswestry Disability Questionnaire
Measured: up to twelve weeks
muscle endurance
Sorensen test (low back fatigue test) and Trunk flexion endurance test will be used for measuring the level of endurance
Measured: up to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start1 Jul 2021 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Model description
- lumbopelvic stabilization and Pilates
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Al Shaymaa Shaaban Abd El Azeim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942782
- Sponsor's protocol ID
- p.t.REC/012/003225
- Acronym
- LBP
- Status last verified
- Jun 2021
- First submitted
- 24 Jun 2021
- Last updated
- 28 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04942782
- Acronym / sponsor ID
- LBP / p.t.REC/012/003225
- Conditions
- Low Back Pain
- Keywords
- lumbopelvaic stabilization exercise, pilates exercise, gait cycle phases, peak pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 28 Jun 2021 (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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- lumbopelvic stabilization and Pilates
| Arm | Type | Receives |
|---|---|---|
| lumbopelvic stabilization exercises | Experimental | Other: lumbopelvic stabilization exercises, Other: conventional therapythe patients will receive trunk stabilization exercise +strengthening exercises for the abdominal, back, and hip muscles three times/ week for three months |
| Pilates exercises | Experimental | Other: pilates exercise, Other: conventional therapythe patients will receive trunk pilates exercise +strengthening exercises for the abdominal, back, and hip muscles three times/ week for three months |
| conventional therapy | Active comparator | Other: conventional therapythe patients will receive trunk stabilization exercise three times/ week for three months |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| lumbopelvic stabilization exercisesthe 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 | Other | lumbopelvic stabilization exercises |
| pilates exercisethe 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 | Other | Pilates exercises |
| conventional therapyPatients 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 | Other | Pilates exercises, conventional therapy, lumbopelvic stabilization exercises |
Primary outcome
gait cycle phases and maximum peak pressure on foot
Time frame: up to twelve weeks
gait cycle phases and peak pressure will be measure by Tekscan walkway
3 secondary outcomes
pain intensity
Time frame: up to twelve weeks
disability
Time frame: up to twelve weeks
muscle endurance
Time frame: up to twelve weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing lumbopelvic stabilization exercises, pilates exercise and conventional therapy in people with Low Back Pain, run by Cairo University.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact al shaymaa sh abd el azeim, lecturer (01033771553, alshaymaa.shaaban@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gait cycle phases and maximum peak pressure on foot (time frame: up to twelve weeks). 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 28 Jun 2021.