Low Back PainNCT05748509
COMPARISON OF THE LUMBAR EXTANSOR MUSCLES' ACTIVATIONS
An observational study of Low Back Pain, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
Low back pain is a public health problem faced by 65-80% of the world's population at some point in their lives. Although the prognosis for low back pain is considered good, 80% of patients with acute low back pain recover within 6 weeks, and 7-10% of them have complaints that last longer than 3 months and become… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Surface EMG activations
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Mar 2023to 20 May 2023
- Phase
- Observational
- 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 30 years
- All sexes
- Adult
Study population: Individuals who agreed to participate in the study were determined as individuals between the ages of 18-30.
Who may be able to join
- Individuals who agreed to participate in the study
- Individuals between the ages of 18-30
Who cannot join
- Individuals with congenital lumbar pathology,
- who had previously operated on the back, lumbar region
- who had scoliosis
- who had a length difference in the lower extremities
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Ankara, Etlik, 06010
ÇAĞLAR SOYLU, MSc, 05078593595, fztcaglar5187@gmail.com
About this study
Official title: COMPARISON OF THE LUMBAR EXTANSOR MUSCLES' ACTIVATIONS DURING DIFFERENT LOW BACK EXERCISES
Low back pain is a public health problem faced by 65-80% of the world's population at some point in their lives. Although the prognosis for low back pain is considered good, 80% of patients with acute low back pain recover within 6 weeks, and 7-10% of them have complaints that last longer than 3 months and become chronic, causing great labor and economic loss.
A multidisciplinary approach is often required in the treatment of low back pain, which is one of the most common diseases in the society and one of the most expensive diseases in terms of both labor loss and treatment cost. In this approach, waist exercises and waist protection training are accepted as an effective and economical method. In our society, there is no conscious education and exercise habits about the techniques of protecting back health. Most patients with chronic low back pain initially ignore low back pain, but apply to health centers when symptoms related to low back pathology become severe. In many studies, it has been shown that strong waist and abdominal muscles and good physical condition reduce musculoskeletal damage in low back traumas. Most studies show that back extensors and flexors are of low strength in patients with low back pain compared to asymptomatic individuals. In the study conducted by Lee et al. on 3000 male workers, it was found that low back pain was lower in those with exercise habits. In a systematic review and meta-analysis conducted in 2017, it was reported that leisure time physical activity can reduce the risk of chronicity of nonspecific low back pain by 11-16%.
When the literature is examined, it is seen that there are different exercise approaches recommended for the conservative treatment of low back pain. There are studies reporting that pilates is effective in terms of pain, disability, kinesiophobia, function, quality of life, flexibility and balance in patients with low back pain and that it has no harmful effects. In another study, it was reported that traditional Chinese exercises are effective in terms of pain, disability and cognitive function in low back pain, and interventions performed 1-2 times a week and 3-4 times a week are associated with reduced pain. Liu et al. In a study conducted in 2019 by Chen-style Tai Chi in individuals aged 50 years and older with chronic nonspecific low back pain, it was found that Chen style Tai Chi reduced pain but did not improve lower extremity proprioception. Wieland et al. showed that yoga led to small or moderate improvements in low back-related functions at three and six months, compared with non-exercise controls in chronic nonspecific low back pain. However, while there are only subjective measurements in the literature about which one is more effective, there is no evidence that includes objective measurements. For this purpose, in this study, the investigators aim to determine which of the different exercises recommended for low back pain contract the muscle more effectively and compare these measurements with anthropometric measurements.
- Conditions
- Low Back Pain
- Being tested
- Surface EMG activations
- Keywords
- Lumbal Lordosis, Thoracic Kyphosis, Muscle Activation, Low Back 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.
Surface EMG activationsOther
We will try to find out which of the exercises such as pressing the back back, waist extension on the balance ball, lumbar extension in the active prone position, Superman exercises have better lumbar extensor muscle activations. Muscle activations of individuals will be evaluated using superficial EMG. An 8-channel EMG Noraxon MiniDTS system (Noraxon, USA, Inc, Scottsdale, AZ) will be used to measure signals from the muscles.
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface EMG activations
The investigators will try to find out which of the exercises such as pressing the back back, waist extension on the balance ball, lumbar extension in the active prone position, Superman exercises have better lumbar extensor muscle activations. Muscle activations of individuals will be evaluated using superficial EMG. An 8-channel EMG Noraxon MiniDTS system (Noraxon, USA, Inc, Scottsdale, AZ) will be used to measure signals from the muscles.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start22 Mar 2023 (estimated)
- Primary completion22 Apr 2023 (estimated)
- Study completion20 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748509
- Sponsor's protocol ID
- 2022-141
- Status last verified
- Mar 2023
- First submitted
- 20 Feb 2023
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Soylu C, Atalay ES, Turker D, Sahan TY, Un Yildirim N. Impact of the Abdominal Drawing-In Maneuver on Spinal Extensor Muscle Activity: A Randomized Controlled Double-Blind Trial Involving Individuals with Non-Specific Low Back Pain. Int J Environ Res Public Health. 2024 Dec 16;21(12):1675. doi: 10.3390/ijerph21121675.
PubMed 39767514
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF THE LUMBAR EXTANSOR MUSCLES' ACTIVATIONS DURING DIFFERENT LOW BACK EXERCISES
- ClinicalTrials.gov ID
- NCT05748509
- Acronym / sponsor ID
- 2022-141
- Conditions
- Low Back Pain
- Keywords
- Lumbal Lordosis, Thoracic Kyphosis, Muscle Activation, Low Back Exercises
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 22 Mar 2023 (estimated)
- Primary completion
- 22 Apr 2023 (estimated)
- Study completion
- 20 May 2023 (estimated)
- First posted
- 28 Feb 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.
Low back pain is a public health problem faced by 65-80% of the world's population at some point in their lives. Although the prognosis for low back pain is considered good, 80% of patients with acute low back pain recover within 6 weeks, and 7-10% of them have complaints that last longer than 3 months and become chronic, causing great labor and economic loss.
A multidisciplinary approach is often required in the treatment of low back pain, which is one of the most common diseases in the society and one of the most expensive diseases in terms of both labor loss and treatment cost. In this approach, waist exercises and waist protection training are accepted as an effective and economical method. In our society, there is no conscious education and exercise habits about the techniques of protecting back health. Most patients with chronic low back pain initially ignore low back pain, but apply to health centers when symptoms related to low back pathology become severe. In many studies, it has been shown that strong waist and abdominal muscles and good physical condition reduce musculoskeletal damage in low back traumas. Most studies show that back extensors and flexors are of low strength in patients with low back pain compared to asymptomatic individuals. In the study conducted by Lee et al. on 3000 male workers, it was found that low back pain was lower in those with exercise habits. In a systematic review and meta-analysis conducted in 2017, it was reported that leisure time physical activity can reduce the risk of chronicity of nonspecific low back pain by 11-16%.
When the literature is examined, it is seen that there are different exercise approaches recommended for the conservative treatment of low back pain. There are studies reporting that pilates is effective in terms of pain, disability, kinesiophobia, function, quality of life, flexibility and balance in patients with low back pain and that it has no harmful effects. In another study, it was reported that traditional Chinese exercises are effective in terms of pain, disability and cognitive function in low back pain, and interventions performed 1-2 times a week and 3-4 times a week are associated with reduced pain. Liu et al. In a study conducted in 2019 by Chen-style Tai Chi in individuals aged 50 years and older with chronic nonspecific low back pain, it was found that Chen style Tai Chi reduced pain but did not improve lower extremity proprioception. Wieland et al. showed that yoga led to small or moderate improvements in low back-related functions at three and six months, compared with non-exercise controls in chronic nonspecific low back pain. However, while there are only subjective measurements in the literature about which one is more effective, there is no evidence that includes objective measurements. For this purpose, in this study, the investigators aim to determine which of the different exercises recommended for low back pain contract the muscle more effectively and compare these measurements with anthropometric measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Age groups
- Adult
- Study population
- Individuals who agreed to participate in the study were determined as individuals between the ages of 18-30.
Key inclusion criteria (2 listed)
- Individuals who agreed to participate in the study
- Individuals between the ages of 18-30
Key exclusion criteria (4 listed)
- Individuals with congenital lumbar pathology,
- who had previously operated on the back, lumbar region
- who had scoliosis
- who had a length difference in the lower extremities
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 |
|---|---|---|
| Surface EMG activationsWe will try to find out which of the exercises such as pressing the back back, waist extension on the balance ball, lumbar extension in the active prone position, Superman exercises have better lumbar extensor muscle activations. Muscle activations of individuals will be evaluated using superficial EMG. An 8-channel EMG Noraxon MiniDTS system (Noraxon, USA, Inc, Scottsdale, AZ) will be used to measure signals from the muscles. | Other | – |
Primary outcome
Surface EMG activations
Time frame: 4 weeks
The investigators will try to find out which of the exercises such as pressing the back back, waist extension on the balance ball, lumbar extension in the active prone position, Superman exercises have better lumbar extensor muscle activations. Muscle activations of individuals will be evaluated using superficial EMG. An 8-channel EMG Noraxon MiniDTS system (Noraxon, USA, Inc, Scottsdale, AZ) will be used to measure signals from the muscles.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Derived from this study: PubMed 39767514Soylu C, Atalay ES, Turker D, Sahan TY, Un Yildirim N. Impact of the Abdominal Drawing-In Maneuver on Spinal Extensor Muscle Activity: A Randomized Controlled Double-Blind Trial Involving Individuals with Non-Specific Low Back Pain. Int J Environ Res Public Health. 2024 Dec 16;21(12):1675. doi: 10.3390/ijerph21121675.
- Individual participant dataSharing planned: Undecided
Related trials for Low Back Pain
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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 3 Mar 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caglar Soylu, PhD (+905078593595, caglar.soylu@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surface EMG activations (time frame: 4 weeks). 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 NCT05748509, which also lists 1 linked publication.
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 3 Mar 2023.