Clinical trial NCT06203340: Lumbar School Training or Core Stabilization Exercises on Pain, Mobilization and Quality of Life Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Core Stability
Core-based Exercise
Back School
Keywords: Back schools
Low back pain
Exercise
Physical therapy
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Posttest and control grouped randomized controlled clinical trial
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Evaluation will be made before and after treatment. The evaluation is expected to take 20 minutes in total.
measure: Oswestry Disability Index
timeFrame: Evaluation will be made before and after treatment. The evaluation is expected to take 20 minutes in total.
measure: World Health Organization Quality of Life Module (WHOQOL-BREF)
timeFrame: Evaluation will be made before and after treatment. The evaluation is expected to take 20 minutes in total.
measure: Lumbar flexion (Hand-finger ground distance)
timeFrame: Evaluation will be made before and after treatment. The evaluation is expected to take 20 minutes in total.
measure: Lumbar lateral flexion
timeFrame: Evaluation will be made before and after treatment. The evaluation is expected to take 20 minutes in total.
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Musa Çankaya
Study officials:
affiliation: Seydişehir Devlet Hastanesi (Seydişehir/KONYA
name: Havva CİNGÖZ, M.Dr.
role: STUDY_CHAIR
affiliation: Necmettin Erbakan University
name: Musa Çankaya, Pt. PhD
role: STUDY_DIRECTOR
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