NCT06203340

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

January 2, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2024

Completed
Last Updated

January 23, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

December 27, 2023

Last Update Submit

January 21, 2025

Conditions

Keywords

Back schoolsLow back painExercisePhysical therapy

Outcome Measures

Primary Outcomes (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Study Arms (3)

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.

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.

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.

Interventions

Lumbal back schooL

Also known as: Exercise training:
Core stabilisation trainingLumbar school training

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Musa Çankaya

Konya, Konya, 42100, Turkey (Türkiye)

Location

Related Publications (11)

  • 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.

    PMID: 31631992BACKGROUND
  • Ghaderi 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.

    PMID: 38318303BACKGROUND
  • Alqhtani 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.

    PMID: 38256609BACKGROUND
  • Jenks 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.

    PMID: 35584027BACKGROUND
  • Rajfur 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.

    PMID: 36138055BACKGROUND
  • Kleine-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.

    PMID: 35947884BACKGROUND
  • Lara-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.

    PMID: 35346331BACKGROUND
  • Kim 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.

    PMID: 32669487BACKGROUND
  • Minghelli 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.

    PMID: 33921952BACKGROUND
  • 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.

    PMID: 32723088BACKGROUND
  • Hajihasani 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.

    PMID: 30266349BACKGROUND

MeSH Terms

Conditions

Low Back PainMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Havva CİNGÖZ, M.Dr.

    Seydişehir Devlet Hastanesi (Seydişehir/KONYA

    STUDY CHAIR
  • Musa Çankaya, Pt. PhD

    Necmettin Erbakan University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Posttest and control grouped randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Doctor

Study Record Dates

First Submitted

December 27, 2023

First Posted

January 12, 2024

Study Start

January 2, 2024

Primary Completion

May 5, 2024

Study Completion

September 7, 2024

Last Updated

January 23, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations