Patients With Chronic Mechanical LBPNCT06634511
Core Stability Exercise Versus Aerobic Exercise on Pain, Range of Motion and Function in Patients With Chronic Mechanical Low Back Pain: Randomized Controlled Trial
A study testing core stability exercises in people with Patients With Chronic Mechanical LBP, run by Cairo University at 1 site in Saudi Arabia.
Trial summary
Chronic mechanical low back pain (CMLBP) is a prevalent musculoskeletal condition characterized by persistent pain originating from the spine, muscles, ligaments, or intervertebral discs. It is one of the leading causes of disability worldwide. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Patients With Chronic Mechanical LBP
- What is being tested?
- core stability exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Oct 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All females between 18-45 years have mechanical LBP more than 3 months
Who cannot join
- Patients will be excluded if they evaluated patients with nerve root compromise, metabolic or serious spinal pathologies (e.g., fractures, tumors, inflammatory, and infectious diseases), previous spinal surgery, postpartum low back pain or pelvic pain due to pregnancy, and pain unrelated to the lower back.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
Jouf university
Qurayyat, Jouf
Zeinab Ali, assistant professor, 00966557647507, zeinaboh4@gmail.com
About this study
Chronic mechanical low back pain (CMLBP) is a prevalent musculoskeletal condition characterized by persistent pain originating from the spine, muscles, ligaments, or intervertebral discs. It is one of the leading causes of disability worldwide. (CMLBP) have significantly affected the individual's physical, emotional, and social well-being, as well as their overall quality of life, functional capacity, and productivity of individuals. Unlike acute low back pain, which typically resolves within a few weeks, CMLBP persists for more than three months and often fluctuates in intensity, leading to recurrent episodes of pain and discomfort [1]. Chronic mechanical low back pain (LBP) has been the subject of extensive research, with numerous studies highlighting its multifactorial nature and varied treatment outcomes. Previous research has established that chronic mechanical LBP often results from prolonged strain on the lumbar spine due to poor posture, repetitive stress, or underlying musculoskeletal imbalances. Studies have consistently shown that interventions such as physical therapy, which includes strengthening exercises and ergonomic adjustments, can be effective in alleviating symptoms and improving functional outcomes.
However, evidence also suggests that the efficacy of these treatments can be limited by factors such as patient adherence and the presence of psychological components like anxiety and depression.
Read more
Furthermore, recent research emphasizes the importance of a multidisciplinary approach that integrates both physical and psychological therapies to address the complex nature of chronic mechanical LBP more comprehensively [2]. Aerobic exercise involves activities that increase the heart rate and improve cardiovascular endurance. The rationale for using aerobic exercise in the management of CMLBP is based on several physiological mechanisms. Firstly, aerobic exercise enhances blood ow and nutrient delivery to the spine and surrounding musculature, which can promote healing and reduce muscle stiffness.
Secondly, regular aerobic activity has been shown to reduce systemic inflammation and increase endorphin production, both of which can lower pain perception. Additionally, aerobic exercise can improve psychological well-being, which is an important factor given the strong association between chronic pain and mental health conditions like depression and anxiety [1]. Core stability training focuses on strengthening the muscles that support the spine, including the transversus abdominis, multifidus, pelvic floor muscles, and other muscles of the abdomen, lower back, and pelvis. These muscles play a critical role in maintaining spinal stability and proper alignment, which is essential for preventing and managing back pain. Core stability exercises, such as planks, bridges, and lumbar stabilization exercises, aim to enhance the endurance and coordination of these muscles, thereby reducing excessive spinal movements and mechanical strain that can exacerbate pain [3] Aerobic exercise and core stability training are commonly recommended for chronic mechanical low back pain (CMLBP). but to our knowledge, there is insufficient evidence comparing the relative effectiveness of aerobic exercise and core stability training, leaving a gap in understanding which approach provides superior outcomes for CMLBP. So the aim of our study is to compare between the effectiveness of aerobic exercise and core stability training on pain, range of motion, flexibility, and functional abilities in patients of CMLBP.
Read the detailed description
Study Design:
Randomized control trail study. 2.2. Study Area: Faculty of applied medical sciences, physiotherapy department at Jouf University 2.3. Study Population: We will include studies that evaluated patients over 18years of age and below 50 years with chronic non-specific low back pain defined as pain or discomfort lasting more than 12weeks in the region below the last costal margins and above the lower gluteal folds, without symptoms in the lower limbs [4].. 2.3.1. Inclusion Criteria: All females between 18-50 years have mechanical LBP more than 3 months 2.3.2. Exclusion Criteria: Patients will be excluded if they evaluated patients with nerve root compromise, metabolic or serious spinal pathologies (e.g., fractures, tumors, inflammatory, and infectious diseases), previous spinal surgery, postpartum low back pain or pelvic pain due to pregnancy, and pain unrelated to the lower back.
Assessment tools:
Numerical rating scale:
Pain Numeric Rating Scale (PNRS): The PNRS is a straightforward tool where patients rate their pain on a scale from 0 (no pain) to 10 (worst possible pain).
It provides a subjective measure of pain intensity and is widely used due to its simplicity and effectiveness in capturing a patient's perceived pain level, Pain scores were classified as follows: 0 (no pain), 1-3 (mild), 4-7 (moderate), and 8-10 (high) [5].
Range of Motion (ROM):
Lumber ROM will be assessed by A standard gravity-based inclinometer (model A-300; Vertex Co., Taiwan) for assessing flexion, extension and lateral bending
Modified modified schober test for assessment of lumber flexibility: Modified Modified Schober Test (MMST)is a modification of Modified Schober Test(MST) by Van Adrichen and Van der Korst(1973). It uses two marks one over the spine connecting two PSIS and other over 15 cm superior to first mark. It eliminates the errors in identification of lumbosacral junction and make sure that entire lumbarspine was included. [6]
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluatorsFAIRS \& RESEARCH CENTER use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools [7].
- Conditions
- Patients With Chronic Mechanical LBP
- Being tested
- core stability exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
core stability exercisesOther
Also called aerobic exercise
Group A: core stability exercise group:15 Patients assigned to this group will undergo a core stability exercises" ts.2times per week /8weeksin addition to conventional therapy (Infrared radiation (using BL 220 Infrared lamp, MT03009201 model) for 15 minutes, Transcutaneous Electrical Nerve stimulation (using model DX66053, pain modulation mode) for 10 minutes
Group B:(aerobic exercise group) 15 patients will receive aerobic exercise in the form of treadmill for 30 minutes2 session per week/8 weeks
Group C(conventional group): 15 patients will receive Infrared radiation (using BL 220 Infrared lamp, MT03009201 model) for 15 minutes, Transcutaneous Electrical Nerve stimulation (using model DX66053, pain modulation mode) for 10 minutes, Participants were treated twice weekly
| Study group | Role | What they receive |
|---|---|---|
| Core stability exercise group | Experimental | Group A: core stability exercise group:15 Patients assigned to this group will undergo a core stability exercises.2times per week /8weeks.in addition to traditional physical therapy program Receives: Other: core stability exercises |
| aerobic exercise group | Experimental | Group B:(aerobic exercise group) 15 patients will receive aerobic exercise in the form of treadmill for 30 minutes2 session per week/8 weeks Receives: Other: core stability exercises |
| traditional physical therapy group | Experimental | Group C(conventional group): 15 patients will receive Infrared radiation (using BL 220 Infrared lamp, MT03009201 model) for 15 minutes, Transcutaneous Electrical Nerve stimulation (using model DX66053, pain modulation mode) for 10 minutes, Participants were treated twice weekly Receives: Other: core stability exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating scale:
ain Numeric Rating Scale (PNRS): The PNRS is a straightforward tool where patients rate their pain on a scale from 0 (no pain) to 10 (worst possible pain).
It provides a subjective measure of pain intensity and is widely used due to its simplicity and effectiveness in capturing a patient's perceived pain level,
Measured: 1 month
Range of motion Range of Motion (ROM): Range of Motion (ROM):
Lumber ROM will be assessed by A standard gravity-based inclinometer (model A-300; Vertex Co., Taiwan) for assessing flexion, extension and lateral bending
Measured: 1 month
Modified modified schober test for assessment of lumber flexibility:
Modified Modified Schober Test (MMST)is a modification of Modified Schober Test(MST) by Van Adrichen and Van der Korst(1973). It uses two marks one over the spine connecting two PSIS and other over 15 cm superior to first mark. It eliminates the errors in identification of lumbosacral junction and make sure that entire lumbarspine was included.
Measured: 1 month
Secondary outcomes (1)
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire)
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools .
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 posted10 Oct 2024
- Study start15 Oct 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Chronic Mechanical LBPStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeinab Abd el fattah Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634511
- Sponsor's protocol ID
- 2024-96
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Core Stability Exercise Versus Aerobic Exercise on Pain, Range of Motion and Function in Patients With Chronic Mechanical Low Back Pain: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06634511
- Acronym / sponsor ID
- 2024-96
- Conditions
- Patients With Chronic Mechanical LBP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 10 Oct 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.
Chronic mechanical low back pain (CMLBP) is a prevalent musculoskeletal condition characterized by persistent pain originating from the spine, muscles, ligaments, or intervertebral discs. It is one of the leading causes of disability worldwide. (CMLBP) have significantly affected the individual's physical, emotional, and social well-being, as well as their overall quality of life, functional capacity, and productivity of individuals. Unlike acute low back pain, which typically resolves within a few weeks, CMLBP persists for more than three months and often fluctuates in intensity, leading to recurrent episodes of pain and discomfort [1]. Chronic mechanical low back pain (LBP) has been the subject of extensive research, with numerous studies highlighting its multifactorial nature and varied treatment outcomes. Previous research has established that chronic mechanical LBP often results from prolonged strain on the lumbar spine due to poor posture, repetitive stress, or underlying musculoskeletal imbalances. Studies have consistently shown that interventions such as physical therapy, which includes strengthening exercises and ergonomic adjustments, can be effective in alleviating symptoms and improving functional outcomes.
However, evidence also suggests that the efficacy of these treatments can be limited by factors such as patient adherence and the presence of psychological components like anxiety and depression.
Furthermore, recent research emphasizes the importance of a multidisciplinary approach that integrates both physical and psychological therapies to address the complex nature of chronic mechanical LBP more comprehensively [2]. Aerobic exercise involves activities that increase the heart rate and improve cardiovascular endurance. The rationale for using aerobic exercise in the management of CMLBP is based on several physiological mechanisms. Firstly, aerobic exercise enhances blood ow and nutrient delivery to the spine and surrounding musculature, which can promote healing and reduce muscle stiffness.
Secondly, regular aerobic activity has been shown to reduce systemic inflammation and increase endorphin production, both of which can lower pain perception. Additionally, aerobic exercise can improve psychological well-being, which is an important factor given the strong association between chronic pain and mental health conditions like depression and anxiety [1]. Core stability training focuses on strengthening the muscles that support the spine, including the transversus abdominis, multifidus, pelvic floor muscles, and other muscles of the abdomen, lower back, and pelvis. These muscles play a critical role in maintaining spinal stability and proper alignment, which is essential for preventing and managing back pain. Core stability exercises, such as planks, bridges, and lumbar stabilization exercises, aim to enhance the endurance and coordination of these muscles, thereby reducing excessive spinal movements and mechanical strain that can exacerbate pain [3] Aerobic exercise and core stability training are commonly recommended for chronic mechanical low back pain (CMLBP). but to our knowledge, there is insufficient evidence comparing the relative effectiveness of aerobic exercise and core stability training, leaving a gap in understanding which approach provides superior outcomes for CMLBP. So the aim of our study is to compare between the effectiveness of aerobic exercise and core stability training on pain, range of motion, flexibility, and functional abilities in patients of CMLBP.
Detailed description
Study Design:
Randomized control trail study. 2.2. Study Area: Faculty of applied medical sciences, physiotherapy department at Jouf University 2.3. Study Population: We will include studies that evaluated patients over 18years of age and below 50 years with chronic non-specific low back pain defined as pain or discomfort lasting more than 12weeks in the region below the last costal margins and above the lower gluteal folds, without symptoms in the lower limbs [4].. 2.3.1. Inclusion Criteria: All females between 18-50 years have mechanical LBP more than 3 months 2.3.2. Exclusion Criteria: Patients will be excluded if they evaluated patients with nerve root compromise, metabolic or serious spinal pathologies (e.g., fractures, tumors, inflammatory, and infectious diseases), previous spinal surgery, postpartum low back pain or pelvic pain due to pregnancy, and pain unrelated to the lower back.
Assessment tools:
Numerical rating scale:
Pain Numeric Rating Scale (PNRS): The PNRS is a straightforward tool where patients rate their pain on a scale from 0 (no pain) to 10 (worst possible pain).
It provides a subjective measure of pain intensity and is widely used due to its simplicity and effectiveness in capturing a patient's perceived pain level, Pain scores were classified as follows: 0 (no pain), 1-3 (mild), 4-7 (moderate), and 8-10 (high) [5].
Range of Motion (ROM):
Lumber ROM will be assessed by A standard gravity-based inclinometer (model A-300; Vertex Co., Taiwan) for assessing flexion, extension and lateral bending
Modified modified schober test for assessment of lumber flexibility: Modified Modified Schober Test (MMST)is a modification of Modified Schober Test(MST) by Van Adrichen and Van der Korst(1973). It uses two marks one over the spine connecting two PSIS and other over 15 cm superior to first mark. It eliminates the errors in identification of lumbosacral junction and make sure that entire lumbarspine was included. [6]
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluatorsFAIRS \& RESEARCH CENTER use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools [7].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Core stability exercise group | Experimental | Other: core stability exercisesGroup A: core stability exercise group:15 Patients assigned to this group will undergo a core stability exercises.2times per week /8weeks.in addition to traditional physical therapy program |
| aerobic exercise group | Experimental | Other: core stability exercisesGroup B:(aerobic exercise group) 15 patients will receive aerobic exercise in the form of treadmill for 30 minutes2 session per week/8 weeks |
| traditional physical therapy group | Experimental | Other: core stability exercisesGroup C(conventional group): 15 patients will receive Infrared radiation (using BL 220 Infrared lamp, MT03009201 model) for 15 minutes, Transcutaneous Electrical Nerve stimulation (using model DX66053, pain modulation mode) for 10 minutes, Participants were treated twice weekly |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All females between 18-45 years have mechanical LBP more than 3 months
Key exclusion criteria (1 listed)
- Patients will be excluded if they evaluated patients with nerve root compromise, metabolic or serious spinal pathologies (e.g., fractures, tumors, inflammatory, and infectious diseases), previous spinal surgery, postpartum low back pain or pelvic pain due to pregnancy, and pain unrelated to the lower back.
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 |
|---|---|---|
| core stability exercisesAlso: aerobic exerciseGroup A: core stability exercise group:15 Patients assigned to this group will undergo a core stability exercises" ts.2times per week /8weeksin addition to conventional therapy (Infrared radiation (using BL 220 Infrared lamp, MT03009201 model) for 15 minutes, Transcutaneous Electrical Nerve stimulation (using model DX66053, pain modulation mode) for 10 minutes Group B:(aerobic exercise group) 15 patients will receive aerobic exercise in the form of treadmill for 30 minutes2 session per week/8 weeks Group C(conventional group): 15 patients will receive Infrared radiation (using BL 220 Infrared lamp, MT03009201 model) for 15 minutes, Transcutaneous Electrical Nerve stimulation (using model DX66053, pain modulation mode) for 10 minutes, Participants were treated twice weekly | Other | Core stability exercise group, aerobic exercise group, traditional physical therapy group |
Primary outcome
Numerical rating scale:
Time frame: 1 month
ain Numeric Rating Scale (PNRS): The PNRS is a straightforward tool where patients rate their pain on a scale from 0 (no pain) to 10 (worst possible pain). It provides a subjective measure of pain intensity and is widely used due to its simplicity and effectiveness in capturing a patient's perceived pain level,
Range of motion Range of Motion (ROM): Range of Motion (ROM):
Time frame: 1 month
Lumber ROM will be assessed by A standard gravity-based inclinometer (model A-300; Vertex Co., Taiwan) for assessing flexion, extension and lateral bending
Modified modified schober test for assessment of lumber flexibility:
Time frame: 1 month
Modified Modified Schober Test (MMST)is a modification of Modified Schober Test(MST) by Van Adrichen and Van der Korst(1973). It uses two marks one over the spine connecting two PSIS and other over 15 cm superior to first mark. It eliminates the errors in identification of lumbosacral junction and make sure that entire lumbarspine was included.
1 secondary outcome
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire)
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Patients With Chronic Mechanical LBP
Not yet recruiting
Effects of a Protocol of Hip Flexor Stretching on Chronic Mechanical, Non-specific LBP.
Pain, Musculoskeletal Manipulations
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing core stability exercises in people with Patients With Chronic Mechanical LBP, run by Cairo University at 1 site in Saudi Arabia.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical rating scale: (time frame: 1 month). The study lists 3 primary outcomes in all. 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 10 Oct 2024.