Low Back PainLowbackpainNCT06203340
Lumbar School Training or Core Stabilization Exercises on Pain, Mobilization and Quality of Life Low Back Pain
A study testing Core stabilizasyon and lumbal back school in people with Low Back Pain and Core Stability, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
Chronic low back pain (CLBP) is defined as low back pain lasting longer than three months. CLBP is one of the most common and expensive diseases in terms of both labour loss and treatment costs, and it is very important to treat it with conventional (non-surgical) treatment methods. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Core Stability, Core-based Exercise
- What is being tested?
- Core stabilizasyon and lumbal back school
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2024to 7 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18 and 55,
- Having low back pain for at least 3 months (12 hf),
- Score 14% or more on the Oswestry Disability Index,
- Ability to move independently (with or without assistance), to participate in a rehabilitation program and to read, write and understand Turkish well enough to complete questionnaires independently.
Who cannot join
- VAS score < 20 mm),
- Those with cognitive impairment that prevents them from understanding and completing the questionnaire,
- Aphasic patients, patients unwilling to volunteer, patients with specific etiology of low back pain such as inflammatory, infectious, tumoral, fracture and visceral pain.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effectiveness of Lumbar Training or Core Stabilisation Exercises on Pain, Mobilisation and Quality of Life in Patients With Chronic Low Back Pain: A Randomised Controlled Study
Chronic low back pain (CLBP) is defined as low back pain lasting longer than three months. CLBP is one of the most common and expensive diseases in terms of both labour loss and treatment costs, and it is very important to treat it with conventional (non-surgical) treatment methods. Clinical guidelines recommend active treatments that address psychosocial factors and focus on functional improvement. Within this approach, low back protection training, called low back school, is recognised as an effective and economical method. This study was planned to investigate the effectiveness of lumbar school training or core stabilisation exercises on pain, mobilisation and quality of life in patients with chronic low back pain.
In this research, patients coming to Seydişehir State Hospital physiotherapy unit will be included in the study. Patients will be taken in Seydişehir Vocational School of Health Services Vocational School vocational skills laboratory and Seydişehir State Hospital physiotherapy unit. As a result of the power analysis, 64 patients are planned to be included. Simple randomisation will be used. Sealed opaque envelopes will be prepared by the research team. Opaque envelopes will be determined as 24 (core exercise group) and 24 (B) (lumbar school), 24 C kontrol. The pain intensity of the patients will be determined by the Visual Analogue Scale, which is a self-report scale, and the functional disability levels will be determined by the Oswestry Disability Index and the quality of life levels will be determined by the World Health Organization Quality of Life Module (WHOQOL-BREF) and spinal mobility will be determined by measuring the hand-finger ground distance.
Read more
Patients will be divided into two groups as core exercise group and lumbar school training group and will be evaluated before and after treatment and training.
Keywords: Chronic low back pain, back school, core stabilisation exercise
Read the detailed description
Low back pain is defined as pain, increased muscle tension or stiffness localised between the costal margin and lower gluteal folds and associated with lower extremity pain (1).
Between 70-85% of people experience low back pain throughout their lives. Almost 20% of these cases become permanent (2). Chronic low back pain (CLBP) is defined as low back pain lasting longer than three months. It is a worldwide common disease that imposes a significant medical and economic burden on individuals and society (3). Mechanical low back pain is defined as a clinical picture that develops as a result of overuse, strain or traumatisation or deformation of the structures forming the spine. In order to define low back pain as mechanical, all organic causes such as inflammatory, infectious, tumoural, metabolic causes, fractures and pain reflected from internal organs should be excluded (4).
It is very important that CLBP, which is very common in the society and is one of the most expensive diseases in terms of both labour loss and treatment cost, is treated with conventional (non-surgical) treatment methods (7). It has been reported that medical, psychological, physical approaches and multidisciplinary methods are effective in the treatment of CLBP(13). In the last thirty years, changes have been made in the basic recommendations in clinical practice guidelines. Self-management, physical, psychological therapies and some complementary medicine treatments are now given more importance and pharmacological and surgical treatments are less preferred. Guidelines recommend active treatments that address psychosocial factors and focus on functional recovery (14). Within this approach, waist protection training, which is called waist school, is accepted as an effective and economical method (5).
The lumbar school method was developed by Mariane Zachrisson Forssel in Sweden in 1969 with the aim of managing the patient's current condition and preventing recurrent low back pain (6). The programme consists of 4 sessions lasting approximately 45 minutes and each session is organised with theoretical components and includes exercises to improve mobility (5). Standard training strategies can be used in patients with chronic low back pain. However, it is not sufficient as a treatment alone. Standard training strategies should include exercise-related practices (7). Clinical guidelines state that trunk coordination, strengthening and endurance exercises should be utilised to reduce the disability in CLBP (7,8). Various therapeutic exercises are applied in clinical practice for CBLP patients.
Core stabilisation exercises (CSE) are based on a motor learning approach and provide the activation of the transversus abdominis and lumbar multifidus muscles together. These deep stabilisation muscles increase intra-abdominal pressure by adhering to the thoraco-lumbar fascia. It has a firming effect on the lumbar spine. It increases the segmental stability of the spine (9). In addition, CSE reduces pain by reversing the pain-related structuring in the motor cortex. It improves muscle strength and improves neuromuscular control of spinal stability. CSE increases the sense of proprioception and successfully corrects postural disorders (10).
Although many different interventions are widely used in physiotherapy clinics, there are few studies evaluating the effects of lumbar school and CSE, and no studies comparing their effectiveness with each other have been found. Therefore, the aim of the present study was to investigate the comparative efficacy of lumbar school training or core stabilisation exercises on pain, mobilisation and quality of life in patients with CBLP.
- Conditions
- Low Back Pain, Core Stability, Core-based Exercise, Back School
- Being tested
- Core stabilizasyon and lumbal back school
- Keywords
- Back schools, Low back pain, Exercise, Physical therapy
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stabilizasyon and lumbal back schoolOther
Also called Exercise training:
Lumbal back schooL
| Study group | Role | What they receive |
|---|---|---|
| Lumbar school training | Experimental | Lumbar back school is a programme for patient groups that provides information about the anatomy, biomechanics, optimal posture, ergonomics and lumbar exercises.
The aim of the lumbar lumbar school school is to reduce low back pain and to teach the individual to take care of his lumbar. It is applied to increase the skills of individuals to solve the problems they encounter in daily life and to teach them ways of coping. Assessment of the patient, explanation of the anatomy, functions and pathophysiology of low back pain, appropriate posture, use of correct body mechanics and theoretical explanation of exercise. Receives: Other: Core stabilizasyon and lumbal back school |
| Core stabilisation training | Experimental | Core exercise programmes are designed to improve stabilisation, strength and power. Core exercise programmes are aimed to improve the sense of bodily movement and position (proprioception), which systematically progresses, prepares for activities and goals. Patients are started from the beginning level of the core exercises and in the following weeks, to the extent that the patients can do will be made more difficult. Receives: Other: Core stabilizasyon and lumbal back school |
| Control group | No intervention | Patients with a previous diagnosis of pain in the lumbar region will be sought. Patients will be invited to the institution and will be informed about low back pain. Patients with low back pain will be evaluated with self-report scales and functional tests. No treatment will be applied as a treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
It is a scale that assesses the severity of pain and consists of a single 10-centimeter line. Patients will be asked to mark the intensity of their pain at rest, during activity (movement) and at night on two separate 10-centimeter lines. The starting point on the scale is defined as no pain and the end point is defined as the most severe unbearable pain. During the calculation, the distance between the marked point and the starting point is measured in centimeters. The relationship of pain intensity with activity (VAS-movement, VAS-rest) and night pain (VAS-night) will be questioned separately. An increase in the score means an increase in pain intensity.
Measured: Evaluation will be made before and after treatment. The evaluation is expected to take 20 minutes in total.
Oswestry Disability Index
It was developed to evaluate the degree of loss of function in low back pain. The Oswestry Disability Index, whose validity and reliability in Turkish was demonstrated in 2004, consists of 10 items. Items question pain severity, self-care, lifting and carrying, walking, sitting, standing, sleep, degree of pain change, travel and social life. Under each item there are six statements in which the patient ticks the one appropriate to his/her situation. The first statement is scored as "0" and the sixth statement is scored as "5". When the total score is calculated, it is multiplied by two and expressed as a percentage. The maximum score is "100" and the minimum score is "0". As the total score increases, the disability level also increases.
Measured: Evaluation will be made before and after treatment. The evaluation is expected to take 20 minutes in total.
World Health Organization Quality of Life Module (WHOQOL-BREF)
WHOQOL, a general-purpose quality of life profile scale, has two versions: long and short. The health-related quality of life scale was developed by WHO and its validity and reliability were tested by Eser et al. The scale has two versions: long (WHOQOL-100) and short (WHOQOL-27) form. The scale measures physical, spiritual, social and environmental well-being and consists of 26 questions. The scale can be applied to non-elderly adults. The scale was also applied to healthcare workers. Since each domain expresses the quality of life in its own field independently of each other, domain scores are calculated between 4-20. As the score increases, the quality of life increases.
Measured: Evaluation will be made before and after treatment. The evaluation is expected to take 20 minutes in total.
Lumbar flexion (Hand-finger ground distance)
HFGD, the patient was asked to stand in an upright posture on a horizontal straight line with a distance of 30 cm between both medial malleolus and to evaluate his hands on the ground without bending his knees. The distance between the middle finger and the floor will be measured.
It will also be evaluated with an inclinometer. It was developed by Mayer et al. This technique, recommended by the American Medical Association, is a non-invasive and easy-to-apply method. The advantages of the method are its low cost, ability to evaluate pelvic and lumbar spine movements separately, and easy applicability. Its validity and reliability have been demonstrated by many studies.
Measured: Evaluation will be made before and after treatment. The evaluation is expected to take 20 minutes in total.
Lumbar lateral flexion
The distance between the fingertip and the ground will be measured while the patient is standing, then he will be asked to lean to the right side and the distance between the ground and the fingertip will be measured again. The same process will be repeated for the left side and the average of the measurements of the right and left sides will be recorded.
Measured: Evaluation will be made before and after treatment. The evaluation is expected to take 20 minutes in total.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start2 Jan 2024
- Primary completion5 May 2024
- Study completion7 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Posttest and control grouped randomized controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MUSA ÇANKAYA, Necmettin Erbakan University
- Investigators
- Havva CİNGÖZ, M.Dr., Study chair, Seydişehir Devlet Hastanesi (Seydişehir/KONYAMusa Çankaya, Pt. PhD, Study director, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203340
- Sponsor's protocol ID
- MUSACANKAYA
- Acronym
- Lowbackpain
- Status last verified
- Jan 2025
- First submitted
- 27 Dec 2023
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozsoy G, Ilcin N, Ozsoy I, Gurpinar B, Buyukturan O, Buyukturan B, Kararti C, Sas S. The Effects Of Myofascial Release Technique Combined With Core Stabilization Exercise In Elderly With Non-Specific Low Back Pain: A Randomized Controlled, Single-Blind Study. Clin Interv Aging. 2019 Oct 9;14:1729-1740. doi: 10.2147/CIA.S223905. eCollection 2019.
PubMed 31631992Ghaderi Niri H, Ghanavati T, Mostafaee N, Salahzadeh Z, Divandari A, Adigozali H, Ahadi J. Oswestry Disability Index, Roland-Morris Disability Questionnaire, and Quebec Back Pain Disability Scale: Responsiveness and Minimal Clinically Important Changes in Iranian People with Lumbar Disc Herniation Following Physiotherapy. Arch Bone Jt Surg. 2024;12(1):58-65. doi: 10.22038/ABJS.2023.72246.3366.
PubMed 38318303Alqhtani RS, Ahmed H, Ghulam HSH, Alyami AM, Al Sharyah YHH, Ahmed R, Khan A, Khan AR. Efficacy of Core-Strengthening and Intensive Dynamic Back Exercises on Pain, Core Muscle Endurance, and Functional Disability in Patients with Chronic Non-Specific Low Back Pain: A Randomized Comparative Study. J Clin Med. 2024 Jan 15;13(2):475. doi: 10.3390/jcm13020475.
PubMed 38256609Jenks A, Hoekstra T, van Tulder M, Ostelo RW, Rubinstein SM, Chiarotto A. Roland-Morris Disability Questionnaire, Oswestry Disability Index, and Quebec Back Pain Disability Scale: Which Has Superior Measurement Properties in Older Adults With Low Back Pain? J Orthop Sports Phys Ther. 2022 Jul;52(7):457-469. doi: 10.2519/jospt.2022.10802. Epub 2022 May 18.
PubMed 35584027Rajfur J, Rajfur K, Kosowski L, Walewicz K, Dymarek R, Ptaszkowski K, Taradaj J. The effectiveness of dry needling in patients with chronic low back pain: a prospective, randomized, single-blinded study. Sci Rep. 2022 Sep 22;12(1):15803. doi: 10.1038/s41598-022-19980-1.
PubMed 36138055Kleine-Borgmann J, Dietz TN, Schmidt K, Bingel U. No long-term effects after a 3-week open-label placebo treatment for chronic low back pain: a 3-year follow-up of a randomized controlled trial. Pain. 2023 Mar 1;164(3):645-652. doi: 10.1097/j.pain.0000000000002752. Epub 2022 Aug 10.
PubMed 35947884Lara-Palomo IC, Gil-Martinez E, Antequera-Soler E, Castro-Sanchez AM, Fernandez-Sanchez M, Garcia-Lopez H. Electrical dry needling versus conventional physiotherapy in the treatment of active and latent myofascial trigger points in patients with nonspecific chronic low back pain. Trials. 2022 Mar 28;23(1):238. doi: 10.1186/s13063-022-06179-y.
PubMed 35346331Kim B, Yim J. Core Stability and Hip Exercises Improve Physical Function and Activity in Patients with Non-Specific Low Back Pain: A Randomized Controlled Trial. Tohoku J Exp Med. 2020 Jul;251(3):193-206. doi: 10.1620/tjem.251.193.
PubMed 32669487Minghelli B, Nunes C, Oliveira R. Back School Postural Education Program: Comparison of Two Types of Interventions in Improving Ergonomic Knowledge about Postures and Reducing Low Back Pain in Adolescents. Int J Environ Res Public Health. 2021 Apr 22;18(9):4434. doi: 10.3390/ijerph18094434.
PubMed 33921952Ahmadi 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 32723088Hajihasani A, Rouhani M, Salavati M, Hedayati R, Kahlaee AH. The Influence of Cognitive Behavioral Therapy on Pain, Quality of Life, and Depression in Patients Receiving Physical Therapy for Chronic Low Back Pain: A Systematic Review. PM R. 2019 Feb;11(2):167-176. doi: 10.1016/j.pmrj.2018.09.029. Epub 2019 Feb 11.
PubMed 30266349
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Lumbar Training or Core Stabilisation Exercises on Pain, Mobilisation and Quality of Life in Patients With Chronic Low Back Pain: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06203340
- Acronym / sponsor ID
- Lowbackpain / MUSACANKAYA
- Conditions
- Low Back Pain, Core Stability, Core-based Exercise, Back School
- Keywords
- Back schools, Low back pain, Exercise, Physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 5 May 2024 (actual)
- Study completion
- 7 Sep 2024 (actual)
- First posted
- 12 Jan 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 low back pain (CLBP) is defined as low back pain lasting longer than three months. CLBP is one of the most common and expensive diseases in terms of both labour loss and treatment costs, and it is very important to treat it with conventional (non-surgical) treatment methods. Clinical guidelines recommend active treatments that address psychosocial factors and focus on functional improvement. Within this approach, low back protection training, called low back school, is recognised as an effective and economical method. This study was planned to investigate the effectiveness of lumbar school training or core stabilisation exercises on pain, mobilisation and quality of life in patients with chronic low back pain.
In this research, patients coming to Seydişehir State Hospital physiotherapy unit will be included in the study. Patients will be taken in Seydişehir Vocational School of Health Services Vocational School vocational skills laboratory and Seydişehir State Hospital physiotherapy unit. As a result of the power analysis, 64 patients are planned to be included. Simple randomisation will be used. Sealed opaque envelopes will be prepared by the research team. Opaque envelopes will be determined as 24 (core exercise group) and 24 (B) (lumbar school), 24 C kontrol. The pain intensity of the patients will be determined by the Visual Analogue Scale, which is a self-report scale, and the functional disability levels will be determined by the Oswestry Disability Index and the quality of life levels will be determined by the World Health Organization Quality of Life Module (WHOQOL-BREF) and spinal mobility will be determined by measuring the hand-finger ground distance.
Patients will be divided into two groups as core exercise group and lumbar school training group and will be evaluated before and after treatment and training.
Keywords: Chronic low back pain, back school, core stabilisation exercise
Detailed description
Low back pain is defined as pain, increased muscle tension or stiffness localised between the costal margin and lower gluteal folds and associated with lower extremity pain (1).
Between 70-85% of people experience low back pain throughout their lives. Almost 20% of these cases become permanent (2). Chronic low back pain (CLBP) is defined as low back pain lasting longer than three months. It is a worldwide common disease that imposes a significant medical and economic burden on individuals and society (3). Mechanical low back pain is defined as a clinical picture that develops as a result of overuse, strain or traumatisation or deformation of the structures forming the spine. In order to define low back pain as mechanical, all organic causes such as inflammatory, infectious, tumoural, metabolic causes, fractures and pain reflected from internal organs should be excluded (4).
It is very important that CLBP, which is very common in the society and is one of the most expensive diseases in terms of both labour loss and treatment cost, is treated with conventional (non-surgical) treatment methods (7). It has been reported that medical, psychological, physical approaches and multidisciplinary methods are effective in the treatment of CLBP(13). In the last thirty years, changes have been made in the basic recommendations in clinical practice guidelines. Self-management, physical, psychological therapies and some complementary medicine treatments are now given more importance and pharmacological and surgical treatments are less preferred. Guidelines recommend active treatments that address psychosocial factors and focus on functional recovery (14). Within this approach, waist protection training, which is called waist school, is accepted as an effective and economical method (5).
The lumbar school method was developed by Mariane Zachrisson Forssel in Sweden in 1969 with the aim of managing the patient's current condition and preventing recurrent low back pain (6). The programme consists of 4 sessions lasting approximately 45 minutes and each session is organised with theoretical components and includes exercises to improve mobility (5). Standard training strategies can be used in patients with chronic low back pain. However, it is not sufficient as a treatment alone. Standard training strategies should include exercise-related practices (7). Clinical guidelines state that trunk coordination, strengthening and endurance exercises should be utilised to reduce the disability in CLBP (7,8). Various therapeutic exercises are applied in clinical practice for CBLP patients.
Core stabilisation exercises (CSE) are based on a motor learning approach and provide the activation of the transversus abdominis and lumbar multifidus muscles together. These deep stabilisation muscles increase intra-abdominal pressure by adhering to the thoraco-lumbar fascia. It has a firming effect on the lumbar spine. It increases the segmental stability of the spine (9). In addition, CSE reduces pain by reversing the pain-related structuring in the motor cortex. It improves muscle strength and improves neuromuscular control of spinal stability. CSE increases the sense of proprioception and successfully corrects postural disorders (10).
Although many different interventions are widely used in physiotherapy clinics, there are few studies evaluating the effects of lumbar school and CSE, and no studies comparing their effectiveness with each other have been found. Therefore, the aim of the present study was to investigate the comparative efficacy of lumbar school training or core stabilisation exercises on pain, mobilisation and quality of life in patients with CBLP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Posttest and control grouped randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Lumbar school training | Experimental | Other: Core stabilizasyon and lumbal back schoolLumbar back school is a programme for patient groups that provides information about the anatomy, biomechanics, optimal posture, ergonomics and lumbar exercises. The aim of the lumbar lumbar school school is to reduce low back pain and to teach the individual to take care of his lumbar. It is applied to increase the skills of individuals to solve the problems they encounter in daily life and to teach them ways of coping. Assessment of the patient, explanation of the anatomy, functions and pathophysiology of low back pain, appropriate posture, use of correct body mechanics and theoretical explanation of exercise. |
| Core stabilisation training | Experimental | Other: Core stabilizasyon and lumbal back schoolCore exercise programmes are designed to improve stabilisation, strength and power. Core exercise programmes are aimed to improve the sense of bodily movement and position (proprioception), which systematically progresses, prepares for activities and goals. Patients are started from the beginning level of the core exercises and in the following weeks, to the extent that the patients can do will be made more difficult. |
| Control group | No intervention | –Patients with a previous diagnosis of pain in the lumbar region will be sought. Patients will be invited to the institution and will be informed about low back pain. Patients with low back pain will be evaluated with self-report scales and functional tests. No treatment will be applied as a treatment. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between the ages of 18 and 55,
- Having low back pain for at least 3 months (12 hf),
- Score 14% or more on the Oswestry Disability Index,
- Ability to move independently (with or without assistance), to participate in a rehabilitation program and to read, write and understand Turkish well enough to complete questionnaires independently.
Key exclusion criteria (3 listed)
- VAS score < 20 mm),
- Those with cognitive impairment that prevents them from understanding and completing the questionnaire,
- Aphasic patients, patients unwilling to volunteer, patients with specific etiology of low back pain such as inflammatory, infectious, tumoral, fracture and visceral pain.
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 stabilizasyon and lumbal back schoolAlso: Exercise training:Lumbal back schooL | Other | Core stabilisation training, Lumbar school training |
Primary outcome
Visual Analog Scale
Time frame: Evaluation will be made before and after treatment. The evaluation is expected to take 20 minutes in total.
It is a scale that assesses the severity of pain and consists of a single 10-centimeter line. Patients will be asked to mark the intensity of their pain at rest, during activity (movement) and at night on two separate 10-centimeter lines. The starting point on the scale is defined as no pain and the end point is defined as the most severe unbearable pain. During the calculation, the distance between the marked point and the starting point is measured in centimeters. The relationship of pain intensity with activity (VAS-movement, VAS-rest) and night pain (VAS-night) will be questioned separately. An increase in the score means an increase in pain intensity.
Oswestry Disability Index
Time frame: Evaluation will be made before and after treatment. The evaluation is expected to take 20 minutes in total.
It was developed to evaluate the degree of loss of function in low back pain. The Oswestry Disability Index, whose validity and reliability in Turkish was demonstrated in 2004, consists of 10 items. Items question pain severity, self-care, lifting and carrying, walking, sitting, standing, sleep, degree of pain change, travel and social life. Under each item there are six statements in which the patient ticks the one appropriate to his/her situation. The first statement is scored as "0" and the sixth statement is scored as "5". When the total score is calculated, it is multiplied by two and expressed as a percentage. The maximum score is "100" and the minimum score is "0". As the total score increases, the disability level also increases.
World Health Organization Quality of Life Module (WHOQOL-BREF)
Time frame: Evaluation will be made before and after treatment. The evaluation is expected to take 20 minutes in total.
WHOQOL, a general-purpose quality of life profile scale, has two versions: long and short. The health-related quality of life scale was developed by WHO and its validity and reliability were tested by Eser et al. The scale has two versions: long (WHOQOL-100) and short (WHOQOL-27) form. The scale measures physical, spiritual, social and environmental well-being and consists of 26 questions. The scale can be applied to non-elderly adults. The scale was also applied to healthcare workers. Since each domain expresses the quality of life in its own field independently of each other, domain scores are calculated between 4-20. As the score increases, the quality of life increases.
Lumbar flexion (Hand-finger ground distance)
Time frame: Evaluation will be made before and after treatment. The evaluation is expected to take 20 minutes in total.
HFGD, the patient was asked to stand in an upright posture on a horizontal straight line with a distance of 30 cm between both medial malleolus and to evaluate his hands on the ground without bending his knees. The distance between the middle finger and the floor will be measured. It will also be evaluated with an inclinometer. It was developed by Mayer et al. This technique, recommended by the American Medical Association, is a non-invasive and easy-to-apply method. The advantages of the method are its low cost, ability to evaluate pelvic and lumbar spine movements separately, and easy applicability. Its validity and reliability have been demonstrated by many studies.
Lumbar lateral flexion
Time frame: Evaluation will be made before and after treatment. The evaluation is expected to take 20 minutes in total.
The distance between the fingertip and the ground will be measured while the patient is standing, then he will be asked to lean to the right side and the distance between the ground and the fingertip will be measured again. The same process will be repeated for the left side and the average of the measurements of the right and left sides will be recorded.
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 23 Jan 2025.
- Results publication: PubMed 31631992Ozsoy G, Ilcin N, Ozsoy I, Gurpinar B, Buyukturan O, Buyukturan B, Kararti C, Sas S. The Effects Of Myofascial Release Technique Combined With Core Stabilization Exercise In Elderly With Non-Specific Low Back Pain: A Randomized Controlled, Single-Blind Study. Clin Interv Aging. 2019 Oct 9;14:1729-1740. doi: 10.2147/CIA.S223905. eCollection 2019.
- Results publication: PubMed 38318303Ghaderi Niri H, Ghanavati T, Mostafaee N, Salahzadeh Z, Divandari A, Adigozali H, Ahadi J. Oswestry Disability Index, Roland-Morris Disability Questionnaire, and Quebec Back Pain Disability Scale: Responsiveness and Minimal Clinically Important Changes in Iranian People with Lumbar Disc Herniation Following Physiotherapy. Arch Bone Jt Surg. 2024;12(1):58-65. doi: 10.22038/ABJS.2023.72246.3366.
- Results publication: PubMed 38256609Alqhtani RS, Ahmed H, Ghulam HSH, Alyami AM, Al Sharyah YHH, Ahmed R, Khan A, Khan AR. Efficacy of Core-Strengthening and Intensive Dynamic Back Exercises on Pain, Core Muscle Endurance, and Functional Disability in Patients with Chronic Non-Specific Low Back Pain: A Randomized Comparative Study. J Clin Med. 2024 Jan 15;13(2):475. doi: 10.3390/jcm13020475.
- Results publication: PubMed 35584027Jenks A, Hoekstra T, van Tulder M, Ostelo RW, Rubinstein SM, Chiarotto A. Roland-Morris Disability Questionnaire, Oswestry Disability Index, and Quebec Back Pain Disability Scale: Which Has Superior Measurement Properties in Older Adults With Low Back Pain? J Orthop Sports Phys Ther. 2022 Jul;52(7):457-469. doi: 10.2519/jospt.2022.10802. Epub 2022 May 18.
- Results publication: PubMed 36138055Rajfur J, Rajfur K, Kosowski L, Walewicz K, Dymarek R, Ptaszkowski K, Taradaj J. The effectiveness of dry needling in patients with chronic low back pain: a prospective, randomized, single-blinded study. Sci Rep. 2022 Sep 22;12(1):15803. doi: 10.1038/s41598-022-19980-1.
- Results publication: PubMed 35947884Kleine-Borgmann J, Dietz TN, Schmidt K, Bingel U. No long-term effects after a 3-week open-label placebo treatment for chronic low back pain: a 3-year follow-up of a randomized controlled trial. Pain. 2023 Mar 1;164(3):645-652. doi: 10.1097/j.pain.0000000000002752. Epub 2022 Aug 10.
- Results publication: PubMed 35346331Lara-Palomo IC, Gil-Martinez E, Antequera-Soler E, Castro-Sanchez AM, Fernandez-Sanchez M, Garcia-Lopez H. Electrical dry needling versus conventional physiotherapy in the treatment of active and latent myofascial trigger points in patients with nonspecific chronic low back pain. Trials. 2022 Mar 28;23(1):238. doi: 10.1186/s13063-022-06179-y.
- Results publication: PubMed 32669487Kim B, Yim J. Core Stability and Hip Exercises Improve Physical Function and Activity in Patients with Non-Specific Low Back Pain: A Randomized Controlled Trial. Tohoku J Exp Med. 2020 Jul;251(3):193-206. doi: 10.1620/tjem.251.193.
- Results publication: PubMed 33921952Minghelli B, Nunes C, Oliveira R. Back School Postural Education Program: Comparison of Two Types of Interventions in Improving Ergonomic Knowledge about Postures and Reducing Low Back Pain in Adolescents. Int J Environ Res Public Health. 2021 Apr 22;18(9):4434. doi: 10.3390/ijerph18094434.
- Results publication: 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.
- Results publication: PubMed 30266349Hajihasani A, Rouhani M, Salavati M, Hedayati R, Kahlaee AH. The Influence of Cognitive Behavioral Therapy on Pain, Quality of Life, and Depression in Patients Receiving Physical Therapy for Chronic Low Back Pain: A Systematic Review. PM R. 2019 Feb;11(2):167-176. doi: 10.1016/j.pmrj.2018.09.029. Epub 2019 Feb 11.
- 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.
Havva CİNGÖZ, M.Dr. study chair
Seydişehir Devlet Hastanesi (Seydişehir/KONYA
Musa Çankaya, Pt. PhD study director
Necmettin Erbakan 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 stabilizasyon and lumbal back school in people with Low Back Pain and Core Stability, run by Necmettin Erbakan 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 4 inclusion and 3 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 23 Jan 2025. 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?
Visual Analog Scale (time frame: Evaluation will be made before and after treatment. The evaluation is expected to take 20 minutes in total.). The study lists 5 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 NCT06203340, which also lists 11 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 23 Jan 2025.