Low Back Pain, MechanicalNCT05854758
Effects of Core Strengthening on Mechanical Low Back Pain in Overweight Adults.
A study testing Core strengthening with conventional treatment and Conventional treatment in people with Low Back Pain, Mechanical and Overweight, run by Riphah International University at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to determine the effects of core strengthening on mechanical back pain in overweight adults. The main question is aims to answer: Is there an effect of core strengthening on mechanical back pain in overweight adults? The participants will be divided into two groups; group A and group… Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Low Back Pain, Mechanical, Overweight
- What is being tested?
- Core strengthening with conventional treatment and Conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2022to 8 Jul 2023
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males \& Female
- Age: 25-45
- Chronic low back pain for more than 3 months .
- BMI of 25 or greater
- Body fat percentage > 25%
- Numerical Pain Rating Scale ratings less than 7
Who cannot join
- Participant failing to fall in this category would be excluded of the study.
- Patients with non-mechanical low back pain
- Patients with acute low back pain.
- Post laminectomy/discectomy
- Spondylolisthesis
- Osteoporosis/Fractures
Show all 11Show fewer
- Cauda equine syndrome
- Recent history of spinal trauma or surgery
- Lumbar myelopathy
- Patients with known metabolic diseases
- Patients with any neurological deficit
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Elite Physical Therapy Centre
Rawalpindi, Punjab Province, 46000
About this study
Official title: Effects of Core Strengthening on Mechanical Back Pain in Overweight Adults.
The goal of this clinical trial is to determine the effects of core strengthening on mechanical back pain in overweight adults.
The main question is aims to answer:
Read more
Is there an effect of core strengthening on mechanical back pain in overweight adults? The participants will be divided into two groups; group A and group B Group A will perform core strengthening after baseline treatment of therapeutic hot pack and Trans continuous mode for 10 minutes.
Group B will perform conventional exercises after baseline treatment of therapeutic hot pack and transcutaneous electrical nerve stimulation. continuous mode for 10 minutes. Each exercise will be repeated 10 times, with 10 second holds, followed by a five-minute rest interval.
Read the detailed description
Low back pain (LBP) is defined as low back pain that keep on for more than 3 months, and it is the most commonly reported clinical symptom of orthopedic diseases. Low back pain has been the leading cause of disability globally for at least the past three decades and results in enormous direct healthcare and lost productivity costs. More than 50% of people in the United States are affected by LBP, and it is the primary cause of work nonappearance and everlasting disability. The core muscles, which are the primary muscle group for maintaining spinal strength, can be separated into two groups according to their functions and attributes.
The origin of LBP is complex, several of which are unidentified. Management of chronic low back pain (CLBP) is often multidisciplinary, involving a combination of treatments, including therapeutic exercises. Core stability exercises aim to improve pain and disability in CLBP increasing spinal stability, neuromuscular control, and preventing shear force that causes injury to the lumbar spine. One major cause involves the weakening of the shallow trunk and abdominal muscles. Another cause of CLBP is the deteriorating of or insufficient motor control of the deep trunk muscles, such as the lumbar multifidus and transversus abdominis. Lumbar multifidus (LM), the main trunk stabilization muscle, may have reduced efficiency 24 h after the onset of acute LBP.
During physical activities, the trunk muscle tissues ensure the mobility and stability of the lumbopelvic region; thus, changes in trunk muscle activity (particularly in the lumbar multifidus and transversus abdominis) are typically observed in patients with low back pain. Stabilization exercise programs have been widely applied for LBP treatment because they were effective in reducing LBP and disability. Core strength training is directed at working out the deep trunk muscles. However, autonomous training is challenging for LBP patients despite the existence of numerous core strength training strategies. Furthermore, no standardized system has been established for analyzing and comparing the results of core strength training and typical resistance training (6).
Core strengthening impression have gained increased popularity in low back rehabilitation. Traditional low back pain rehabilitation is based on a stationary spine stability model and is composed mostly of modalities, stretching and strengthening exercises (7). More recent theories, however, include newer concepts of dynamic spinal stability, coordination and neuromuscular control. Core strengthening exercises incorporate these new concepts. Although more research is required, the best available evidence suggests that a core strengthening program may be advantageous in reducing pain scores, functional disability and recurrences of acute low back pain episodes. Strong clinical and emerging epidemiological evidence shows that muscle-strengthening exercises is independently associated with multiple health outcomes, including a reduced risk of all-cause mortality, incidence of diabetes and enhanced metabolic , musculoskeletal and mental health.
Low back pain (LBP) is an economic burden to society, leading to functional disability resulting in loss of number of days at work. Literature review state that 75% or more patients with low back become temporarily disabled and around 5% people suffer from permanent disability .
Diagnosis of mechanical low back pain is commonly made by physical examination, physical tests, palpation, imaging such as x-rays, MRI, and CT scan. Medication, physical therapy, and surgery are most commonly used managements of mechanical low back pain. The physical therapy management varies according to the patient condition, and includes modalities, exercise therapy, manual therapy and patient's education with a comprehensive home plan of care.
The individual effectiveness of manual physical therapy and core stability exercises therapy are evident in the management of mechanical low back pain, but there is no single study available in the literature on the combined effects of physical therapy and core stability exercise therapy. The objective of the current study will be to determine the combined effect of physical therapy and core stability exercise therapy in the management of mechanical low back pain.
The conventional physical therapy is a commonly used management of mechanical low back pain to improve the mobility of the lumbar spine. The core stabilization exercises for strengthening of spinal muscles to improve their ability to maintain neutral spine using the abdominal, back, neck and shoulder girdle muscles as stabilizers rather than movers. Trunk stability exercises that focus on either deep or superficial muscles might produce different effects on lumbar segmental motion .
Obesity is a complex disease that accumulated excess body fat leads to negative effects on health.
Obesity persists to accelerate resulting in an unprecedented epidemic that shows no significant signs of slowing down any time soon. Raised body mass index (BMI) is a risk factor for illness such as diabetes, cardiovascular diseases, and musculoskeletal disorders, resulting in dramatic decrease of life quality and expectancy. The main cause of obesity is long-term energy imbalance between consumed calories and expended calories. Here, The purpose of our study is to find out the effect of core strengthening on LBP and total body fat.
- Conditions
- Low Back Pain, Mechanical, Overweight
- Being tested
- Core strengthening with conventional treatment, Conventional treatment
- Keywords
- low back pain, overweight, exercise, core strengthening, numerical pain rating scale
- Medical subject headings
- Low Back Pain, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core strengthening with conventional treatmentOther
A detailed musculoskeletal examination of lumbar spine will be performed before the start of treatment. Oswestry Low Back Pain Disability Questionnaire for pain will be noted. An expert physical therapist with more than 7 years clinical experience will assist the patients in performing core stabilization exercise with conventional physical therapy protocol and routine physical therapy exercise. The session with the physical therapist will usually last for up to 40 minutes.
This group will perform planks, side planks and superman exercises along with knee to chest, pelvic rotation, back extension, and bridge exercises after baseline treatment of therapeutic hot pack and transcutaneous electrical nerve stimulation. continuous mode for 10 minutes.
Conventional treatmentOther
A detailed musculoskeletal examination of lumbar spine will be performed before the start of treatment. Oswestry Low Back Pain Disability Questionnaire for pain will be noted. An expert physical therapist with more than 7 years clinical experience will assist the patients in performing core stabilization exercise with conventional physical therapy protocol and routine physical therapy exercise. The session with the physical therapist will usually last for up to 40 minutes.
This group will perform knee to chest, pelvic rotation, bridge and back extension exercises after baseline treatment of therapeutic hot pack and transcutaneous electrical nerve stimulation. continuous mode for 10 minutes. Each exercise will be repeated 10 times, with 10 second holds, followed by a five-minute rest interval
| Study group | Role | What they receive |
|---|---|---|
| Core strengthening with conventional treatment | Experimental | This group will perform planks, side planks and superman exercises along with knee to chest, pelvic rotation, back extension, and bridge exercises after baseline treatment of therapeutic hot pack and transcutaneous electrical nerve stimulation continuous mode for 10 minutes. Receives: Other: Core strengthening with conventional treatment |
| Conventional treatment | Active comparator | This group will perform knee to chest, pelvic rotation, bridge and back extension exercises after baseline treatment of therapeutic hot pack and transcutaneous electrical nerve stimulation. continuous mode for 10 minutes. Each exercise will be repeated 10 times, with 10 second holds, followed by a five-minute rest interval Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale
The 11-point Numerical Pain Rating Scale consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The respondent is instructed to identify one number between 0 and 10, which is best representative of their pain intensity
Measured: 6 weeks
Oswestry Low Back Pain Disability Questionnaire
The Oswestry Disability Index (ODI) is one of the most commonly used outcome measures for individuals with low back pain. Psychometric properties of the ODI will determine the questionnaire's suitability as a useful clinical tool. The ODI is a valid, reliable, and responsive condition-specific assessment tool that is suited for use in clinical practice. It is easy to administer and score, objectifies clients' complaints, and monitors effects of therapy
Measured: 6 weeks
Body Mass Index
Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in meters squared. A BMI of 25.0 or more is overweight, while the healthy range is 18.5 to 24.9.
Measured: 6 weeks
Total Body Fat
The Jackson-Pollack method for evaluating body fat percentage requires three skin fold measurements. For men, measurement sites are the chest, abdomen and thigh; for women, they consist of the thigh, triceps and suprailiac crest, or just above the top of the hip bone. Because measurements are taken in very specific spots, precise locations are typically measured and marked with a washable marker before the test is conducted. For consistency and accuracy, all skin fold measurements are taken at least twice on the right side of a standing, relaxed body and should never be taken after exercise, when a person's fluid levels can interfere with accuracy. Measurements are taken on the right side of body. Caliber needs to be perpendicular to the site analyzed.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 Nov 2022
- Primary completion10 Jun 2023
- Study completion8 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jawad Naweed, MS-SPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854758
- Sponsor's protocol ID
- REC/01410 JUNAID UR RAHMAN
- Status last verified
- Jul 2023
- First submitted
- 3 May 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Core Strengthening on Mechanical Back Pain in Overweight Adults.
- ClinicalTrials.gov ID
- NCT05854758
- Acronym / sponsor ID
- REC/01410 JUNAID UR RAHMAN
- Conditions
- Low Back Pain, Mechanical, Overweight
- Keywords
- low back pain, overweight, exercise, core strengthening, numerical pain rating scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 8 Jul 2023 (actual)
- First posted
- 11 May 2023 (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 goal of this clinical trial is to determine the effects of core strengthening on mechanical back pain in overweight adults.
The main question is aims to answer:
Is there an effect of core strengthening on mechanical back pain in overweight adults? The participants will be divided into two groups; group A and group B Group A will perform core strengthening after baseline treatment of therapeutic hot pack and Trans continuous mode for 10 minutes.
Group B will perform conventional exercises after baseline treatment of therapeutic hot pack and transcutaneous electrical nerve stimulation. continuous mode for 10 minutes. Each exercise will be repeated 10 times, with 10 second holds, followed by a five-minute rest interval.
Detailed description
Low back pain (LBP) is defined as low back pain that keep on for more than 3 months, and it is the most commonly reported clinical symptom of orthopedic diseases. Low back pain has been the leading cause of disability globally for at least the past three decades and results in enormous direct healthcare and lost productivity costs. More than 50% of people in the United States are affected by LBP, and it is the primary cause of work nonappearance and everlasting disability. The core muscles, which are the primary muscle group for maintaining spinal strength, can be separated into two groups according to their functions and attributes.
The origin of LBP is complex, several of which are unidentified. Management of chronic low back pain (CLBP) is often multidisciplinary, involving a combination of treatments, including therapeutic exercises. Core stability exercises aim to improve pain and disability in CLBP increasing spinal stability, neuromuscular control, and preventing shear force that causes injury to the lumbar spine. One major cause involves the weakening of the shallow trunk and abdominal muscles. Another cause of CLBP is the deteriorating of or insufficient motor control of the deep trunk muscles, such as the lumbar multifidus and transversus abdominis. Lumbar multifidus (LM), the main trunk stabilization muscle, may have reduced efficiency 24 h after the onset of acute LBP.
During physical activities, the trunk muscle tissues ensure the mobility and stability of the lumbopelvic region; thus, changes in trunk muscle activity (particularly in the lumbar multifidus and transversus abdominis) are typically observed in patients with low back pain. Stabilization exercise programs have been widely applied for LBP treatment because they were effective in reducing LBP and disability. Core strength training is directed at working out the deep trunk muscles. However, autonomous training is challenging for LBP patients despite the existence of numerous core strength training strategies. Furthermore, no standardized system has been established for analyzing and comparing the results of core strength training and typical resistance training (6).
Core strengthening impression have gained increased popularity in low back rehabilitation. Traditional low back pain rehabilitation is based on a stationary spine stability model and is composed mostly of modalities, stretching and strengthening exercises (7). More recent theories, however, include newer concepts of dynamic spinal stability, coordination and neuromuscular control. Core strengthening exercises incorporate these new concepts. Although more research is required, the best available evidence suggests that a core strengthening program may be advantageous in reducing pain scores, functional disability and recurrences of acute low back pain episodes. Strong clinical and emerging epidemiological evidence shows that muscle-strengthening exercises is independently associated with multiple health outcomes, including a reduced risk of all-cause mortality, incidence of diabetes and enhanced metabolic , musculoskeletal and mental health.
Low back pain (LBP) is an economic burden to society, leading to functional disability resulting in loss of number of days at work. Literature review state that 75% or more patients with low back become temporarily disabled and around 5% people suffer from permanent disability .
Diagnosis of mechanical low back pain is commonly made by physical examination, physical tests, palpation, imaging such as x-rays, MRI, and CT scan. Medication, physical therapy, and surgery are most commonly used managements of mechanical low back pain. The physical therapy management varies according to the patient condition, and includes modalities, exercise therapy, manual therapy and patient's education with a comprehensive home plan of care.
The individual effectiveness of manual physical therapy and core stability exercises therapy are evident in the management of mechanical low back pain, but there is no single study available in the literature on the combined effects of physical therapy and core stability exercise therapy. The objective of the current study will be to determine the combined effect of physical therapy and core stability exercise therapy in the management of mechanical low back pain.
The conventional physical therapy is a commonly used management of mechanical low back pain to improve the mobility of the lumbar spine. The core stabilization exercises for strengthening of spinal muscles to improve their ability to maintain neutral spine using the abdominal, back, neck and shoulder girdle muscles as stabilizers rather than movers. Trunk stability exercises that focus on either deep or superficial muscles might produce different effects on lumbar segmental motion .
Obesity is a complex disease that accumulated excess body fat leads to negative effects on health.
Obesity persists to accelerate resulting in an unprecedented epidemic that shows no significant signs of slowing down any time soon. Raised body mass index (BMI) is a risk factor for illness such as diabetes, cardiovascular diseases, and musculoskeletal disorders, resulting in dramatic decrease of life quality and expectancy. The main cause of obesity is long-term energy imbalance between consumed calories and expended calories. Here, The purpose of our study is to find out the effect of core strengthening on LBP and total body fat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core strengthening with conventional treatment | Experimental | Other: Core strengthening with conventional treatmentThis group will perform planks, side planks and superman exercises along with knee to chest, pelvic rotation, back extension, and bridge exercises after baseline treatment of therapeutic hot pack and transcutaneous electrical nerve stimulation continuous mode for 10 minutes. |
| Conventional treatment | Active comparator | Other: Conventional treatmentThis group will perform knee to chest, pelvic rotation, bridge and back extension exercises after baseline treatment of therapeutic hot pack and transcutaneous electrical nerve stimulation. continuous mode for 10 minutes. Each exercise will be repeated 10 times, with 10 second holds, followed by a five-minute rest interval |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males \& Female
- Age: 25-45
- Chronic low back pain for more than 3 months .
- BMI of 25 or greater
- Body fat percentage > 25%
Key exclusion criteria (11 listed)
- Participant failing to fall in this category would be excluded of the study.
- Patients with non-mechanical low back pain
- Patients with acute low back pain.
- Post laminectomy/discectomy
- Spondylolisthesis
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 strengthening with conventional treatmentA detailed musculoskeletal examination of lumbar spine will be performed before the start of treatment. Oswestry Low Back Pain Disability Questionnaire for pain will be noted. An expert physical therapist with more than 7 years clinical experience will assist the patients in performing core stabilization exercise with conventional physical therapy protocol and routine physical therapy exercise. The session with the physical therapist will usually last for up to 40 minutes. This group will perform planks, side planks and superman exercises along with knee to chest, pelvic rotation, back extension, and bridge exercises after baseline treatment of therapeutic hot pack and transcutaneous electrical nerve stimulation. continuous mode for 10 minutes. | Other | Core strengthening with conventional treatment |
| Conventional treatmentA detailed musculoskeletal examination of lumbar spine will be performed before the start of treatment. Oswestry Low Back Pain Disability Questionnaire for pain will be noted. An expert physical therapist with more than 7 years clinical experience will assist the patients in performing core stabilization exercise with conventional physical therapy protocol and routine physical therapy exercise. The session with the physical therapist will usually last for up to 40 minutes. This group will perform knee to chest, pelvic rotation, bridge and back extension exercises after baseline treatment of therapeutic hot pack and transcutaneous electrical nerve stimulation. continuous mode for 10 minutes. Each exercise will be repeated 10 times, with 10 second holds, followed by a five-minute rest interval | Other | Conventional treatment |
Primary outcome
Numerical Pain Rating Scale
Time frame: 6 weeks
The 11-point Numerical Pain Rating Scale consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The respondent is instructed to identify one number between 0 and 10, which is best representative of their pain intensity
Oswestry Low Back Pain Disability Questionnaire
Time frame: 6 weeks
The Oswestry Disability Index (ODI) is one of the most commonly used outcome measures for individuals with low back pain. Psychometric properties of the ODI will determine the questionnaire's suitability as a useful clinical tool. The ODI is a valid, reliable, and responsive condition-specific assessment tool that is suited for use in clinical practice. It is easy to administer and score, objectifies clients' complaints, and monitors effects of therapy
Body Mass Index
Time frame: 6 weeks
Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in meters squared. A BMI of 25.0 or more is overweight, while the healthy range is 18.5 to 24.9.
Total Body Fat
Time frame: 6 weeks
The Jackson-Pollack method for evaluating body fat percentage requires three skin fold measurements. For men, measurement sites are the chest, abdomen and thigh; for women, they consist of the thigh, triceps and suprailiac crest, or just above the top of the hip bone. Because measurements are taken in very specific spots, precise locations are typically measured and marked with a washable marker before the test is conducted. For consistency and accuracy, all skin fold measurements are taken at least twice on the right side of a standing, relaxed body and should never be taken after exercise, when a person's fluid levels can interfere with accuracy. Measurements are taken on the right side of body. Caliber needs to be perpendicular to the site analyzed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Jawad Naweed, MS-SPT principal investigator
Riphah International University
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 strengthening with conventional treatment and Conventional treatment in people with Low Back Pain, Mechanical and Overweight, run by Riphah International University at 1 site in Pakistan.
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 6 inclusion and 11 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: finished, as of the sponsor's last update on 19 Jul 2023. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Rating Scale (time frame: 6 weeks). The study lists 4 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 19 Jul 2023.