CClinicalTrials.gg
Status unknownNCT05302349Updated Mar 31, 2022

The Effect of Core Stabilization Exercises in People With Chronic Low Back Pain

An interventional study of Core Exercise Group and Routine Therapy Group in Non-specific Low Back Pain, sponsored by Mehmet Akif Guler. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Mehmet Akif Guler · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Low back pain is a health problem that causes clinical, social and economic losses all over the world and affects the majority of the population. More than 80% of adults in the general population experience low back pain at least once in their lifetime. Although the incidence of chronic low back pain is so high, 85% of these pains do not have a pathoanatomical cause and these pains are defined as non-specific chronic low back pain. Exercise therapy is the key to the conservative management of nonspecific chronic low back pain. Lumbar stabilization exercises based on the principle of motor control of core muscles have also become popular in rehabilitation programs for low back pain in recent years.The core region is the lumbopelvic region of the body. The aim of the stabilization exercises is to teach to use the neutral position of the lumbar region and to keep the load on the dynamic and static structures at the lowest level. Core stabilization training begins with teaching the contraction of the transversus abdominus, deep spinal and multifidus muscle.Then, these exercises are planned specifically for the person from immobile positions to movements positions, from simple movements to combined movements, from gross patterns to fine motor patterns, from symmetrical movements to asymmetric movements. These exercises can be developed specifically for the region and pathology with the functions of the muscles in the region of the pathology. The lumbar multifidus muscle is known to be an important stabilizer of the lumbar region. In addition, the cross-sectional area of the lumbar multifidus muscle has short, thick, dense muscle fibers compared to other lumbar region muscles.These dense muscle fibers are compressed in a small space and have a high mass.This morphology allows the lumbar multifidus muscle to produce great force in a small working area and makes the muscle ideal for stability. In addition, the position of the lumbar multifidus muscle between the vertebrae increases its importance for stability. The aim of this study is to determine the effects of core stabilization exercises on the cross-sectional area (CSA) and amount of adipose tissue of the lumbar multifidus muscle in adults with chronic low back pain using magnetic resonance imaging (MRI), and also to examine the effects of these exercises on pain, functionality and lumbopelvic stability.

02

Conditions studied

  • Non-specific Low Back Pain

Keywords

  • core exercises
  • multifidus muscle
  • lumbar
  • chronic low back pain
  • Magnetic resonance imaging
  • multifidus cross-sectional area
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's planned enrollment of 36 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Mehmet Akif Guler is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patient with low back pain for at least 3 months or more
  • Age between 18 and 65 years
  • Ability to give informed consent

Exclusion criteria

Exclusion Criteria:

  • History of previous previous spinal surgery
  • Disc herniation with radiculopathy
  • Pregnant or breastfeeding
  • Systemic disease
  • Low back pain due to specific and known causes (Spondylolisthesis, Spinal stenosis, Spondylolysis, Ankylosing spondylitis, Tumor, Structural deformity, Osteoporosis, Rheumatological disease, Infection)
  • History of malignancies/cancer
  • Unexplained or unintentional weight loss
  • Perineal numbness, Bladder dysfunction
  • Progressive weakness in lower limbs
  • Fracture
  • Fever
  • Cauda equina syndrome
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    Core Exercise Group

    Core Exercise Group will performe core stabilization exercises and routine physiotherapy exercises.

    Other: Core Exercise Group

  • Active comparator
    Routine Therapy Group

    Routine Therapy Group will performe routine physiotherapy exercises.

    Other: Routine Therapy Group

Interventions

  • OtherCore Exercise Group

    Core Exercise Group Procedure: Weeks 1-4 (Five days a week) 1. Hotpack ultrasound, conventional TENS, stretching exercises and strengthening exercises for low back pain. 2. Core stabilization exercise : * Active pelvic floor exercise (supine position) * Bridge exercise (supine position) * Back Extension and Ball Back Extension exercises (prone position) * Abdominal and Oblique Crunch exercises (supin position) * Leg lift exercise (prone position) * Plank and Side Plank exercise * Superman exercise Weeks 5-8 (Three days a week) 1. Stretching exercises and strengthening exercises for low back pain. 2. Core stabilization exercise : * The same exercises as for Weeks 1-4 will perform.

  • OtherRoutine Therapy Group

    Routine Therapy Group Procedure: Weeks 1-4 (Five days a week) 1. Hotpack ultrasound, conventional TENS, stretching exercises and strengthening exercises for low back pain. Weeks 5-8 (Three days a week) 1.Stretching exercises and strengthening exercises for low back pain.

06

What researchers measure

Primary outcomes

  1. Measurement of the amount of adipose tissue and CSA of the muscle by MRI

    Axial images obtained from the multi-point DIXON (mDIXON) sequence will be used to determine the cross-sectional area and amount of adipose tissue of the lumbar multifidus muscle. The bilateral cross-sectional areas of the lumbar multifidus muscle from the L1-2, L2-3, L3-4, L4-5 and L5-S1 intervertebral disc levels will be calculated by drawing the outlines of the fascial borders of the muscles. Muscle CSA and amount of adipose tissue will be calculated. Subtracting the amount of adipose tissue from the CSA resulting in the functional CSA of the muscle. There will be two measurements, at baseline before the start of program and at the end of the eight weeks intervention.

    Time frame: Baseline - End of the eighth week

  2. Visual Analog Scale

    Pain will be measured using a 10 cm visual analog scale (VAS). Min pain score is 0, max pain score is 10. Participants will mark a point on the VAS that matches the amount of pain they feel.

    Time frame: Baseline - End of the eighth week

  3. Oswestry Disability Index

    Oswestry Disability Index evaluates the extent to which the patient's level of function is restricted by the pain.. Oswestry Disability Index consists of 10 sections, each section the total possible score is ranging from 0 to 5. The score obtained from all questions is added and multiplied by two. The result is noted as a percentage. * 0% to 20%= Minimal disability * 21% to 40%= Moderate disability * 41% to 60%= Severe disability * 61% to 80%= Crippling back pain * 81% to 100%= Bed-bound or exaggerating symptoms

    Time frame: Baseline - End of the eighth week

  4. Sahrmann Core Stability Test

    The Sahrmann core stability test is a 5-level test used to evaluate the ability of the core muscles to stabilize the spine. While the participant lying in a crook-supine position, the PBU will be inflated to 40 mmHg. Participants will perform the Sahrmann five-level test. A deviation of pressure more than 10 mmHg indicates that the stabilization action of stabilizer muscle has been lost.

    Time frame: Baseline - End of the eighth week

07

Study locations

1 site
  • Selcuk University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
    Konya, Selcuklu 42131, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05302349
Lead sponsor
Mehmet Akif Guler
Collaborators
Ankara Yildirim Beyazıt University
Responsible party
Mehmet Akif Guler (Lecturer, Selcuk University) — Sponsor-investigator
First posted
Mar 31, 2022
Start date
Mar 2022 (estimated)
Primary completion
Sep 1, 2022 (estimated)
Completion
Mar 1, 2023 (estimated)
Last update
Mar 31, 2022

Study contacts

Mehmet Akif Güler
Contact
makif.guler@selcuk.edu.tr
+90 542 464 4209
Mehmet Akif Güler, MSc/PT
principal investigator · Selcuk University / Faculty of Health Sciences / Department of Physiotherapy and Rehabilitation
Ertuğrul Demirdel, Asst. Prof
study chair · Ankara Yildirim Beyazit University / Faculty of Health Sciences / Department of Physiotherapy and Rehabilitation
Ilknur Albayrak Gezer, Assoc. Prof
study director · Selcuk University / Faculty of Medicine / Department of Physical Therapy and Rehabilitation
Alaaddin Nayman, Assoc. Prof
study director · Selcuk University / Faculty of Medicine / Department of Radiology
Ezgi Akyıldız Tezcan, MD
study director · Cumra Public Hospital / Department of Physical Therapy and Rehabilitation

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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