Mechanical Low Back PainNCT06330792
Effect of Bio-mechanical Awareness and Core Stability Exercises on Mechanical Low Back Pain
A study testing bio-mechanical awareness and core stability exercises in people with Mechanical Low Back Pain, run by Cairo University.
Trial summary
investigate the effect of bio-mechanical awareness and core stability exercises on mechanical low back pain among Egyptian Physiotherapists Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Mechanical Low Back Pain
- What is being tested?
- bio-mechanical awareness and core stability exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 4 May 2024to 1 Dec 2024
- 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 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Egyptian Physiotherapists with non-specific low back pain.
- Physiotherapy graduate who worked for at least two years (Khairy et al.,2019).
- Age range from 25 to 40 years old (Pellissier et al., 2023).
- Male and female.
- Normal BMI ranges between 18.5:24.9 kg/m2.
Who cannot join
- Physiotherapists outside the target range age an BMI.
- Students of physical therapy or Physiotherapists who worked for less than two years.
- Physiotherapists who had lumbar spine surgery.
- Physiotherapists who had history sever lumbar problem spondylolisthesis, tumor, fracture.
- Physiotherapists who suffers from vertigo.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Bio-mechanical Awareness and Core Stability Exercises on Mechanical Low Back Pain Among Egyptian Physiotherapists
investigate the effect of bio-mechanical awareness and core stability exercises on mechanical low back pain among Egyptian Physiotherapists
Read the detailed description
The aims of this study are:
- to investigate the effect of bio-mechanical awareness and core stability exercises on the intensity of low back pain among Egyptian Physiotherapists.
- to investigate the effect of bio-mechanical awareness and core stability exercises on and back muscle endurance among Egyptian Physiotherapists.
- to investigate the effect of bio-mechanical awareness and core stability exercises on level of function (disability) associated with low back pain among Egyptian Physiotherapists.
- to investigate the effect of bio-mechanical awareness and core stability exercises on fatigue among Egyptian Physiotherapists.
- to investigate the effect of bio-mechanical awareness and core stability exercises on psycho-social factors at work among Egyptian Physiotherapists.
- Conditions
- Mechanical Low Back Pain
- Being tested
- bio-mechanical awareness, core stability exercises
- Keywords
- mechanical awareness, core stability exercises
- 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.
bio-mechanical awarenessOther
Biomechanical awareness advices for physiotherapists during session: consist of group of awareness advices and McKenzie extension part method exercises to help physiotherapist working in correct position and consume his energy.
core stability exercisesOther
Core stabilization exercise Program: The procedure for core stabilization exercises to improve core muscles in lumbar area
| Study group | Role | What they receive |
|---|---|---|
| effect of biomechanical awareness and core stability exercises on mechanical low back pain | Other | Not described Receives: Other: bio-mechanical awareness; Other: core stability exercises |
| effect core stability exercises on mechanical low back pain | Other | Not described Receives: Other: core stability exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
intensity of low back pain
we will assess intensity of low back pain by using visual analogue scale
Measured: 1 month
Secondary outcomes (4)
back muscle endurance
assess back muscle endurance by using Sorensen test
Measured: 1 month
level of function (disability) associated with mechanical Low Back Pain
the Arabic version of Oswestry Disability Index will be used to determine the level of function associated with mechanical Low Back Pain
Measured: 1 month
Fatigue Severity
The Arabic version of The Fatigue Severity Scale will be used to measure fatigue in people with mechanical Low Back Pain
Measured: 1 month
psycho-social factors at work
The English version of The Brief Job Stress Questionnaire which is valid in the measurement of psycho-social factors at work and this Questionnaire can be one of the methodological tools to explore the mechanisms between job stress and several work-related disorders and can provide hints of intervention.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start4 May 2024 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mechanical 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
- Physiotherapists will be randomly subdivided into two equal groups in number. Group (A) (Experimental Group): This group will receive biomechanical awareness advices while working and core stability exercises. Group (B) (Control Group): This group will receive core stability exercises only.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibrahim Ahmed Baza, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330792
- Sponsor's protocol ID
- mechanical low back pain
- Status last verified
- Apr 2024
- First submitted
- 13 Mar 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.
PubMed 29573870Vieira ER, Svoboda S, Belniak A, Brunt D, Rose-St Prix C, Roberts L, da Costa BR. Work-related musculoskeletal disorders among physical therapists: an online survey. Disabil Rehabil. 2016;38(6):552-7. doi: 10.3109/09638288.2015.1049375. Epub 2015 May 26.
PubMed 26007284Areeudomwong P, Buttagat V. Comparison of Core Stabilisation Exercise and Proprioceptive Neuromuscular Facilitation Training on Pain-related and Neuromuscular Response Outcomes for Chronic Low Back Pain: A Randomised Controlled Trial. Malays J Med Sci. 2019 Nov;26(6):77-89. doi: 10.21315/mjms2019.26.6.8. Epub 2019 Dec 30.
PubMed 31908589
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bio-mechanical Awareness and Core Stability Exercises on Mechanical Low Back Pain Among Egyptian Physiotherapists
- ClinicalTrials.gov ID
- NCT06330792
- Acronym / sponsor ID
- mechanical low back pain
- Conditions
- Mechanical Low Back Pain
- Keywords
- mechanical awareness, core stability exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 May 2024 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 26 Mar 2024 (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.
investigate the effect of bio-mechanical awareness and core stability exercises on mechanical low back pain among Egyptian Physiotherapists
Detailed description
The aims of this study are:
- to investigate the effect of bio-mechanical awareness and core stability exercises on the intensity of low back pain among Egyptian Physiotherapists.
- to investigate the effect of bio-mechanical awareness and core stability exercises on and back muscle endurance among Egyptian Physiotherapists.
- to investigate the effect of bio-mechanical awareness and core stability exercises on level of function (disability) associated with low back pain among Egyptian Physiotherapists.
- to investigate the effect of bio-mechanical awareness and core stability exercises on fatigue among Egyptian Physiotherapists.
- to investigate the effect of bio-mechanical awareness and core stability exercises on psycho-social factors at work among Egyptian Physiotherapists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Physiotherapists will be randomly subdivided into two equal groups in number. Group (A) (Experimental Group): This group will receive biomechanical awareness advices while working and core stability exercises. Group (B) (Control Group): This group will receive core stability exercises only.
| Arm | Type | Receives |
|---|---|---|
| effect of biomechanical awareness and core stability exercises on mechanical low back pain | Other | Other: bio-mechanical awareness, Other: core stability exercises |
| effect core stability exercises on mechanical low back pain | Other | Other: core stability exercises |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Egyptian Physiotherapists with non-specific low back pain.
- Physiotherapy graduate who worked for at least two years (Khairy et al.,2019).
- Age range from 25 to 40 years old (Pellissier et al., 2023).
- Male and female.
- Normal BMI ranges between 18.5:24.9 kg/m2.
Key exclusion criteria (5 listed)
- Physiotherapists outside the target range age an BMI.
- Students of physical therapy or Physiotherapists who worked for less than two years.
- Physiotherapists who had lumbar spine surgery.
- Physiotherapists who had history sever lumbar problem spondylolisthesis, tumor, fracture.
- Physiotherapists who suffers from vertigo.
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 |
|---|---|---|
| bio-mechanical awarenessBiomechanical awareness advices for physiotherapists during session: consist of group of awareness advices and McKenzie extension part method exercises to help physiotherapist working in correct position and consume his energy. | Other | effect of biomechanical awareness and core stability exercises on mechanical low back pain |
| core stability exercisesCore stabilization exercise Program: The procedure for core stabilization exercises to improve core muscles in lumbar area | Other | effect core stability exercises on mechanical low back pain, effect of biomechanical awareness and core stability exercises on mechanical low back pain |
Primary outcome
intensity of low back pain
Time frame: 1 month
we will assess intensity of low back pain by using visual analogue scale
4 secondary outcomes
back muscle endurance
Time frame: 1 month
level of function (disability) associated with mechanical Low Back Pain
Time frame: 1 month
Fatigue Severity
Time frame: 1 month
psycho-social factors at work
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Background: PubMed 29573870Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.
- Background: PubMed 26007284Vieira ER, Svoboda S, Belniak A, Brunt D, Rose-St Prix C, Roberts L, da Costa BR. Work-related musculoskeletal disorders among physical therapists: an online survey. Disabil Rehabil. 2016;38(6):552-7. doi: 10.3109/09638288.2015.1049375. Epub 2015 May 26.
- Background: PubMed 31908589Areeudomwong P, Buttagat V. Comparison of Core Stabilisation Exercise and Proprioceptive Neuromuscular Facilitation Training on Pain-related and Neuromuscular Response Outcomes for Chronic Low Back Pain: A Randomised Controlled Trial. Malays J Med Sci. 2019 Nov;26(6):77-89. doi: 10.21315/mjms2019.26.6.8. Epub 2019 Dec 30.
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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 bio-mechanical awareness and core stability exercises in people with Mechanical 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 5 inclusion and 5 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 25 Apr 2024. 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 Mohamed Baza, B.Sc (+2001017931442, mohamedbaza588@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intensity of low back pain (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06330792, which also lists 3 linked publications.
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 25 Apr 2024.