Lumbar School Training or Core Stabilization Exercises on Pain, Mobilization and Quality of Life Low Back Pain

Low Back Pain Clinical Trial

— Lumbschool  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06203340
• Other study ID #: MUSACANKAYA
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: Necmettin Erbakan University
• Contact: Musa Çankaya, Pt. PhD
• Phone: 05062957382
• Email: musa-cankaya[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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 32 (core exercise group) and 32 (B) (lumbar school). 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: September 30, 2024
• Est. primary completion date: July 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Back Pain
• Core Stability
• Low Back Pain

Intervention

Other:
• Core stabilizasyon and lumbal back school
Lumbal back schooL

Locations

Country	Name	City	State
Turkey	Musa Çankaya	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Necmettin Erbakan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Evaluation will be made before and after treatment. The evaluation is expected to take 20 minutes in total.
Primary	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.	Evaluation will be made before and after treatment. The evaluation is expected to take 20 minutes in total.
Primary	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.	Evaluation will be made before and after treatment. The evaluation is expected to take 20 minutes in total.
Primary	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.	Evaluation will be made before and after treatment. The evaluation is expected to take 20 minutes in total.
Primary	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.	Evaluation will be made before and after treatment. The evaluation is expected to take 20 minutes in total.