Low Back PainNCT05174091
A Comparıson of in People Wıth and Wıthout Non-Specıfıc Low Back Paın
An observational study of Low Back Pain, run by University of Beykent at 1 site in Turkey (Türkiye).
Trial summary
Non-Specific Low Back Pain (NSLBP), which constitutes approximately 90-95% of low back pain, is low back pain that cannot be defined by specific pathologies such as infection, tumor, osteoporosis, fracture, radicular symptoms or inflammatory diseases. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Functional Movement Screen, Spinal Mouse, Core Endurance, Funcitonal Capacity
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 1 Jun 2022
- 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 65 years
- All sexes
- Adult, Older adult
Study population: 18-65, • having pain between the last rib and inferior gluteal region more than 3 months
Who may be able to join
- Being between the ages of 18-65,
- getting more than 24 points in the minimental test,
- having pain between the last rib and inferior gluteal region,
- being diagnosed with NSLBP, presence of low back pain for more than 3 months, -volunteering to participate in the study.
- Being between the ages of 18-65,
- getting over 24 points in the minimental test,
- not having low back pain in the last 3 months,
- volunteering to participate in the study were determined.
Who cannot join
- uncontrollable hypertension and heart disease,
- uncontrollable neurological and metabolic disease,
- trauma history in the last 6 months,
- serious musculoskeletal problem and other pathology that may adversely affect balance,
- severe mental involvement, lower extremity amputation,
- presence of nerve pressure, non-voluntary
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Beykent University
Istanbul, Beylikdüzü, 34100
About this study
Official title: A Comparıson of Functıonal Movemenet Screen, Physıcal Capacıty, Core Endurance, and Spınal Mobılıty in People Wıth and Wıthout Non-Specıfıc Low Back Paın
Non-Specific Low Back Pain (NSLBP), which constitutes approximately 90-95% of low back pain, is low back pain that cannot be defined by specific pathologies such as infection, tumor, osteoporosis, fracture, radicular symptoms or inflammatory diseases. NSLBP creates many health problems due to uncertainties in both its diagnosis and treatment. Due to the health problems and decreased functional activities of the individual, it creates a socioeconomic burden on both the individual and the country. NSLBP ranks 6th in the distribution of the economic burden caused by diseases to developed and developing societies. It is difficult to calculate how much burden it puts on the country's economy both directly (health institutions) and indirectly (loss of working days). However, in 1996 in the United States (USA), the economic burden of NSLBP patients is estimated to be between 18.5 and 28.2 million.
Read the detailed description
Non-Specific Low Back Pain (NSLBP), which constitutes approximately 90-95% of low back pain, is low back pain that cannot be defined by specific pathologies such as infection, tumor, osteoporosis, fracture, radicular symptoms or inflammatory diseases. NSLBP creates many health problems due to uncertainties in both its diagnosis and treatment. Due to the health problems and decreased functional activities of the individual, it creates a socioeconomic burden on both the individual and the country. NSLBP ranks 6th in the distribution of the economic burden caused by diseases to developed and developing societies. It is difficult to calculate how much burden it puts on the country's economy both directly (health institutions) and indirectly (loss of working days). However, in 1996 in the United States (USA), the economic burden of NSLBP patients is estimated to be between 18.5 and 28.2 million.
Although the age of first appearance of NSLBP is in the middle of the second decade and the beginning of the third decade, its prevalence increases until the middle of the sixth decade. NSLBP, which is more common in women aged 40-69 years, is more common in high-income countries. Due to the complex nature of the etiology of NSLBP, it is very difficult to define the risk factors. However, there may be many risk factors such as age, race, gender, muscle strength, body mass index, smoking, spine mobility. Since the underlying cause is not clear, there is currently no suitable evaluation and treatment method. For this, the patient's muscle strength, endurance, range of motion, physical capacity and functional movement analysis should be evaluated and interpreted.
- Conditions
- Low Back Pain
- Being tested
- Functional Movement Screen, Spinal Mouse, Core Endurance, Funcitonal Capacity
- Keywords
- Functional, Movement, Screen, Core, Endurance, Physical capacity
- 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.
Functional Movement Screen, Spinal Mouse, Core Endurance, Funcitonal CapacityOther
Due to the difficulties in the diagnosis and treatment of NSLBP, it has been causing many problems such as limitation of activation, socioeconomic burden, and biopsychosocial factors for years. It is thought that the effectiveness of treatment will increase if the needs and problems of individuals with NSLBP are clearly revealed beforehand. Although there are studies on core endurance and physical capacities in individuals with NSLBP in the literature, the number of studies examining functional movement analysis and spinal mobility in individuals with NSLBP is very few. Therefore, aim of this research is to compare functional movement analysis, physical capacity, core endurance, and spinal mobility in individuals with and without NSLBP. With the results we will reveal, we aim to contribute to the evaluation and treatment of patients with NSLBP. Thus, the negative effects of this pathology, which causes serious labor and financial losses, can be minimized.
| Study group | Role | What they receive |
|---|---|---|
| With Non- Spesific Low Back Pain | FMS, Spinal mobility, Core Endurance, Physical Capacity. Receives: Other: Functional Movement Screen, Spinal Mouse, Core Endurance, Funcitonal Capacity | |
| Without Non- Spesific Low Back Pain | FMS, Spinal mobility, Core Endurance, Physical Capacity. Receives: Other: Functional Movement Screen, Spinal Mouse, Core Endurance, Funcitonal Capacity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Movement Screening (FMS) (Functional Movement Patterns)
FMS will be used to evaluate the quality of 7 functional movement patterns with the goal of identifying movement limitations and asymmetries. The FMS consists of 7 individual test items including the deep squat, in-line lunge, hurdle step, shoulder flexibility, push-up, straight leg raise, and rotary trunk stability assessment. Each of these 7 test items is graded on a scale of 0-3; thus, the lowest and highest possible overall FMS scores are 0 and 21, respectively.
Measured: 1 day
Spinal Mobility
Spinal mobility will be measured with a computer-assisted portable electromechanical device (the Spinal Mouse System, Idiag, Fejraltorf, Switzerland). Measurements will be made with the participant's back naked. Spinous processes between C7 and S3 of the individual will be marked before spinal mouse measurement is made. The C7 spinous process is located between the two rounds of the spinal mouse. It will go down to the S3 vertebra with a speed of 6.7 cm/sec, which measures without disturbing the patient's position. Then, the same measurements will be made between the C7 spinous process and the S3 spinous process while the person is in the position of maximum flexion, extension and right-left lateral flexion.
Measured: 1 day
Secondary outcomes (9)
Oswetry Disability Index
Patients with NSBA may have limitations in activities of daily living. In this study, the disability level of low back pain will be measured with the Oswestry Low Back Pain Disability Questionnaire (ODI). ODI evaluates the person's disability with 10 questions. Each of the titles of pain intensity, personal care activities, lifting, walking, sitting, standing, sleep, sexual life, social life and travel activities are scored between 0-5. The maximum score received in the survey is 100. High scores are associated with higher disability from low back pain.
Measured: 1 day.
Functional Reach Test
The Functional Reach Test is a test used to assess balance. Participants will be asked to stand with their feet shoulder-width apart. There will be a measuring stick attached to the wall at the participant's shoulder level. The participant will be asked to bring the third metacarpophalangeal joint to the starting point of the measuring stick, without touching the wall, with the shoulder joint 90 degrees flexed, elbow in full extension, and hand in the form of a fist. After the physiotherapist who made the assessment marks the starting point, the participant will be asked to reach the maximum distance they can reach without taking a step. The endpoint will be saved at the endpoint. The distance between the start and end point in cm will be measured and recorded. The test will be repeated 3 times and the best score will be recorded
Measured: 1 day.
Two Minutes Step Test
The Two Minute Step Test is a test used to assess a participant's aerobic capacity. It is preferred in the clinic because it can be done in a shorter time than the Six Minute Walk Test, it is safe and does not require expensive equipment. The middle distance between the participant's iliac crest and patella will be marked on the wall. After the test starts, the participant will be asked to take a step on the spot by extending the knee up to the marked line. The number of times the participant brought his right knee up to the line for two minutes will be recorded as the score. The test will be administered once.
Measured: 1 day.
Time Up and Go Test
The Timed Up and Go Test is a test used to evaluate dynamic balance and mobility. This test includes motor tasks such as getting up, walking straight, turning and sitting. Participants will be asked to get up from their seat, turn from the place 3 meters ahead and return to the chair they started from again. The total test time will be recorded in seconds. The test will be repeated 2 times in total and the average of the data obtained will be recorded.
Measured: 1 day.
The Trunk Flexor Endurance Test
The Trunk Flexor Endurance Test is a test that evaluates the endurance of the rectus abdominus muscle. In this test, the participant reclines with his arms crossed at chest level, hips and knees positioned at 90 degrees of flexion, while the top of the bed is at 60 degrees. With the start of the test, the back of the participant who is supported by the bed stays up 10 cm from the bed. The test is terminated when the participant's back touches the bed. The elapsed time is recorded in seconds.
Measured: 1 day
The Trunk Extensor Endurance Test
The Trunk Extensor Muscles Endurance Test is a test used to evaluate the endurance of the muscles in the back of the back. In the prone position, the lower extremity is supported by a belt while the participant is suspended out of the bed at the level of the anterior superior spina illiaca. Before the test starts, the participant carries his weight with the help of a chair, while the chair is taken at the start of the test and the arms are extended parallel to the ground beside the torso. The test is terminated when the participant's body becomes uneven and the elapsed time is recorded in seconds
Measured: 1 day
Trunk Lateral Muscle Endurance Test
In the Trunk Lateral Muscle Endurance test, it is a test used to evaluate the endurance of the internal and external oblique muscles on the lateral side of the abdominal region. The participant places one elbow under his shoulder at 90 degrees of flexion. While the legs are in the extension position in line with the body, the top foot is placed under the bottom foot. The upper hand is placed on the opposite shoulder. The time spent by the participant in this position will be recorded in seconds and repeated for the other party.
Measured: 1 day.
Numeric Pain Rating Scale
The pain intensity of the patients will be measured with the numerical pain intensity scale. On the numerical pain intensity scale, the patient will be asked to give a value between 0 and 10 for his pain. The size of the score indicates that the severity of pain is high.
Measured: 1 day.
Sociodemographic Information
Age (year), height (cm), body weight (kg), body mass index (kg/m2), marital status, duration of pain (months), severity of pain (0-10), location of pain (right) , left, middle), dominant upper extremity (writing hand), occupation, whether the occupation requires movement, education level, smoking and alcohol use, exercise habits, medications used, background, family history and accompanying diseases will be questioned.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start1 Dec 2021
- Primary completion30 Apr 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih ÖZYURT, University of Beykent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174091
- Sponsor's protocol ID
- 15212021
- Status last verified
- Jul 2022
- First submitted
- 13 Dec 2021
- Last updated
- 21 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ahmadi H, Adib H, Selk-Ghaffari M, Shafizad M, Moradi S, Madani Z, Partovi G, Mahmoodi A. Comparison of the effects of the Feldenkrais method versus core stability exercise in the management of chronic low back pain: a randomised control trial. Clin Rehabil. 2020 Dec;34(12):1449-1457. doi: 10.1177/0269215520947069. Epub 2020 Jul 29.
PubMed 32723088Kellis E, Adamou G, Tzilios G, Emmanouilidou M. Reliability of spinal range of motion in healthy boys using a skin-surface device. J Manipulative Physiol Ther. 2008 Oct;31(8):570-6. doi: 10.1016/j.jmpt.2008.09.001.
PubMed 18984239Vachalathiti R, Sakulsriprasert P, Kingcha P. Decreased Functional Capacity in Individuals with Chronic Non-Specific Low Back Pain: A Cross-Sectional Comparative Study. J Pain Res. 2020 Aug 5;13:1979-1986. doi: 10.2147/JPR.S260875. eCollection 2020.
PubMed 32801853Cook G, Burton L, Hoogenboom B. Pre-participation screening: the use of fundamental movements as an assessment of function - part 1. N Am J Sports Phys Ther. 2006 May;1(2):62-72.
PubMed 21522216
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparıson of Functıonal Movemenet Screen, Physıcal Capacıty, Core Endurance, and Spınal Mobılıty in People Wıth and Wıthout Non-Specıfıc Low Back Paın
- ClinicalTrials.gov ID
- NCT05174091
- Acronym / sponsor ID
- 15212021
- Conditions
- Low Back Pain
- Keywords
- Functional, Movement, Screen, Core, Endurance, Physical capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 30 Dec 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.
Non-Specific Low Back Pain (NSLBP), which constitutes approximately 90-95% of low back pain, is low back pain that cannot be defined by specific pathologies such as infection, tumor, osteoporosis, fracture, radicular symptoms or inflammatory diseases. NSLBP creates many health problems due to uncertainties in both its diagnosis and treatment. Due to the health problems and decreased functional activities of the individual, it creates a socioeconomic burden on both the individual and the country. NSLBP ranks 6th in the distribution of the economic burden caused by diseases to developed and developing societies. It is difficult to calculate how much burden it puts on the country's economy both directly (health institutions) and indirectly (loss of working days). However, in 1996 in the United States (USA), the economic burden of NSLBP patients is estimated to be between 18.5 and 28.2 million.
Detailed description
Non-Specific Low Back Pain (NSLBP), which constitutes approximately 90-95% of low back pain, is low back pain that cannot be defined by specific pathologies such as infection, tumor, osteoporosis, fracture, radicular symptoms or inflammatory diseases. NSLBP creates many health problems due to uncertainties in both its diagnosis and treatment. Due to the health problems and decreased functional activities of the individual, it creates a socioeconomic burden on both the individual and the country. NSLBP ranks 6th in the distribution of the economic burden caused by diseases to developed and developing societies. It is difficult to calculate how much burden it puts on the country's economy both directly (health institutions) and indirectly (loss of working days). However, in 1996 in the United States (USA), the economic burden of NSLBP patients is estimated to be between 18.5 and 28.2 million.
Although the age of first appearance of NSLBP is in the middle of the second decade and the beginning of the third decade, its prevalence increases until the middle of the sixth decade. NSLBP, which is more common in women aged 40-69 years, is more common in high-income countries. Due to the complex nature of the etiology of NSLBP, it is very difficult to define the risk factors. However, there may be many risk factors such as age, race, gender, muscle strength, body mass index, smoking, spine mobility. Since the underlying cause is not clear, there is currently no suitable evaluation and treatment method. For this, the patient's muscle strength, endurance, range of motion, physical capacity and functional movement analysis should be evaluated and interpreted.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Non- Spesific Low Back Pain | – | Other: Functional Movement Screen, Spinal Mouse, Core Endurance, Funcitonal CapacityFMS, Spinal mobility, Core Endurance, Physical Capacity. |
| Without Non- Spesific Low Back Pain | – | Other: Functional Movement Screen, Spinal Mouse, Core Endurance, Funcitonal CapacityFMS, Spinal mobility, Core Endurance, Physical Capacity. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 18-65, • having pain between the last rib and inferior gluteal region more than 3 months
Key inclusion criteria (8 listed)
- Being between the ages of 18-65,
- getting more than 24 points in the minimental test,
- having pain between the last rib and inferior gluteal region,
- being diagnosed with NSLBP, presence of low back pain for more than 3 months, -volunteering to participate in the study.
- Being between the ages of 18-65,
Key exclusion criteria (6 listed)
- uncontrollable hypertension and heart disease,
- uncontrollable neurological and metabolic disease,
- trauma history in the last 6 months,
- serious musculoskeletal problem and other pathology that may adversely affect balance,
- severe mental involvement, lower extremity amputation,
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 |
|---|---|---|
| Functional Movement Screen, Spinal Mouse, Core Endurance, Funcitonal CapacityDue to the difficulties in the diagnosis and treatment of NSLBP, it has been causing many problems such as limitation of activation, socioeconomic burden, and biopsychosocial factors for years. It is thought that the effectiveness of treatment will increase if the needs and problems of individuals with NSLBP are clearly revealed beforehand. Although there are studies on core endurance and physical capacities in individuals with NSLBP in the literature, the number of studies examining functional movement analysis and spinal mobility in individuals with NSLBP is very few. Therefore, aim of this research is to compare functional movement analysis, physical capacity, core endurance, and spinal mobility in individuals with and without NSLBP. With the results we will reveal, we aim to contribute to the evaluation and treatment of patients with NSLBP. Thus, the negative effects of this pathology, which causes serious labor and financial losses, can be minimized. | Other | With Non- Spesific Low Back Pain, Without Non- Spesific Low Back Pain |
Primary outcome
Functional Movement Screening (FMS) (Functional Movement Patterns)
Time frame: 1 day
FMS will be used to evaluate the quality of 7 functional movement patterns with the goal of identifying movement limitations and asymmetries. The FMS consists of 7 individual test items including the deep squat, in-line lunge, hurdle step, shoulder flexibility, push-up, straight leg raise, and rotary trunk stability assessment. Each of these 7 test items is graded on a scale of 0-3; thus, the lowest and highest possible overall FMS scores are 0 and 21, respectively.
Spinal Mobility
Time frame: 1 day
Spinal mobility will be measured with a computer-assisted portable electromechanical device (the Spinal Mouse System, Idiag, Fejraltorf, Switzerland). Measurements will be made with the participant's back naked. Spinous processes between C7 and S3 of the individual will be marked before spinal mouse measurement is made. The C7 spinous process is located between the two rounds of the spinal mouse. It will go down to the S3 vertebra with a speed of 6.7 cm/sec, which measures without disturbing the patient's position. Then, the same measurements will be made between the C7 spinous process and the S3 spinous process while the person is in the position of maximum flexion, extension and right-left lateral flexion.
9 secondary outcomes
Oswetry Disability Index
Time frame: 1 day.
Functional Reach Test
Time frame: 1 day.
Two Minutes Step Test
Time frame: 1 day.
Time Up and Go Test
Time frame: 1 day.
The Trunk Flexor Endurance Test
Time frame: 1 day
The Trunk Extensor Endurance Test
Time frame: 1 day
Trunk Lateral Muscle Endurance Test
Time frame: 1 day.
Numeric Pain Rating Scale
Time frame: 1 day.
Sociodemographic Information
Time frame: 1 day
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 21 Jul 2022.
- Background: PubMed 32723088Ahmadi H, Adib H, Selk-Ghaffari M, Shafizad M, Moradi S, Madani Z, Partovi G, Mahmoodi A. Comparison of the effects of the Feldenkrais method versus core stability exercise in the management of chronic low back pain: a randomised control trial. Clin Rehabil. 2020 Dec;34(12):1449-1457. doi: 10.1177/0269215520947069. Epub 2020 Jul 29.
- Background: PubMed 18984239Kellis E, Adamou G, Tzilios G, Emmanouilidou M. Reliability of spinal range of motion in healthy boys using a skin-surface device. J Manipulative Physiol Ther. 2008 Oct;31(8):570-6. doi: 10.1016/j.jmpt.2008.09.001.
- Background: PubMed 32801853Vachalathiti R, Sakulsriprasert P, Kingcha P. Decreased Functional Capacity in Individuals with Chronic Non-Specific Low Back Pain: A Cross-Sectional Comparative Study. J Pain Res. 2020 Aug 5;13:1979-1986. doi: 10.2147/JPR.S260875. eCollection 2020.
- Background: PubMed 21522216Cook G, Burton L, Hoogenboom B. Pre-participation screening: the use of fundamental movements as an assessment of function - part 1. N Am J Sports Phys Ther. 2006 May;1(2):62-72.
- This artickle linked to our researchLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 University of Beykent 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 8 inclusion and 6 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 21 Jul 2022. 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?
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?
Functional Movement Screening (FMS) (Functional Movement Patterns) (time frame: 1 day). The study lists 2 primary outcomes in all. 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 NCT05174091, which also lists 4 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 21 Jul 2022.