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Chronic Low-back Pain (cLBP)NCT07334782

Effects of Vertebral Axial Loading Walking Combined With Core Stabilization Exercises in Individuals With Chronic Low Back Pain

A study testing Exercise - Core Stabilization Exercise Program and Core Stabilization Exercises Plus Vertebral Axial Loading Walking Training in people with Chronic Low-back Pain (cLBP), run by Hacettepe University at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Chronic low back pain is a common musculoskeletal condition persisting for more than three months and is associated with pain, functional limitations, impaired balance, altered proprioception, reduced trunk muscle performance, and decreased quality of life. Read more about this study

Who is it for?
Ages 30 to 55 years
Conditions the study is for
Chronic Low-back Pain (cLBP)
What is being tested?
Exercise - Core Stabilization Exercise Program and Core Stabilization Exercises Plus Vertebral Axial Loading Walking Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteTurkey (Türkiye)
Study dates
19 Jan 2026to 15 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 30 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Aged 30 to 55 years
  • Able to read and write
  • Not using regular medication during the study period
  • Voluntary participation and willingness to comply with study procedures

Who cannot join

  • Presence of lumbar radiculopathy or neurological deficits
  • Presence of specific spinal pathologies, including scoliosis, kyphosis, malignancy, fracture, infection, or inflammatory joint or bone diseases
  • Presence of major or chronic systemic diseases, including diabetes mellitus, rheumatoid arthritis, or systemic lupus erythematosus
  • Presence of any neurological disease, such as stroke, Parkinson's disease, or multiple sclerosis
  • Presence of any condition affecting balance, including cerebellar ataxia, vertigo, Ménière's disease, inner ear labyrinthitis, or vestibular neuritis
  • History of spinal surgery
Show all 16Show fewer
  • History of minimally invasive spinal procedures or injections, including platelet-rich plasma (PRP), growth factor-rich plasma (GFRP), corticosteroids, or other pharmacological injections
  • History of major lower extremity surgery, including knee arthroplasty, hip arthroplasty, high tibial osteotomy, or meniscal surgery
  • Presence of lower extremity musculoskeletal injuries, including meniscal or ligament injuries or chronic ankle instability
  • Presence of lower extremity deformities, including talipes equinovarus, genu varum, genu valgum, or coxa vara/valga
  • Presence of cognitive impairment or diagnosed psychiatric disorders
  • Pregnancy or being less than 6 months postpartum
  • History of cancer or ongoing cancer treatment
  • Illiteracy
  • Failure to attend three consecutive treatment sessions
  • Receipt of physical therapy or rehabilitation within the past 6 months

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hacettepe University, Faculty of Physical Therapy and Rehabilitation

    Ankara, 06100

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Effects of Vertebral Axial Loading Walking Training Added to Core Stabilization Exercises on Pain, Trunk Sensory Function, Muscle Strength and Endurance, Balance, and Proprioception in Patients With Chronic Low Back Pain

Chronic low back pain is a common musculoskeletal condition persisting for more than three months and is associated with pain, functional limitations, impaired balance, altered proprioception, reduced trunk muscle performance, and decreased quality of life. Previous studies have demonstrated that individuals with chronic low back pain exhibit altered sensory input from spinal structures and impaired neuromuscular control, which may contribute to persistent pain and movement dysfunction. Although exercise-based physiotherapy approaches, particularly core stabilization exercises, are widely recommended and effective in the management of chronic low back pain, sensory deficits related to balance, proprioception, and body awareness are often insufficiently addressed in conventional rehabilitation programs.

Vertebral axial loading walking training is a functional rehabilitation approach involving slow, controlled walking under gentle vertical loading applied along the spinal axis. This intervention is thought to enhance afferent sensory input from spinal mechanoreceptors, potentially improving balance control, proprioception, and motor coordination. This randomized controlled study aims to investigate the effects of adding vertebral axial loading walking training to a standard core stabilization exercise program on pain intensity, balance, proprioception, trunk muscle strength and endurance, and body awareness in individuals with chronic low back pain.

Read the detailed description

Chronic low back pain is one of the leading causes of disability worldwide and is characterized not only by persistent pain but also by impairments in postural control, proprioception, trunk muscle function, and body awareness. Neurophysiological studies have demonstrated that individuals with chronic low back pain exhibit altered afferent input from lumbar spinal structures and changes in central nervous system processing, resulting in impaired sensorimotor control and delayed trunk muscle activation. These alterations may negatively affect balance, movement coordination, and functional performance, thereby contributing to the chronicity of symptoms. Core stabilization exercises are commonly prescribed to improve trunk muscle strength, endurance, and neuromuscular control and have demonstrated beneficial effects in individuals with chronic low back pain. However, evidence suggests that traditional exercise programs may not sufficiently stimulate sensory receptors involved in proprioceptive input and postural regulation. Impaired proprioception and reduced body awareness have been identified as key factors associated with ongoing pain and functional limitations in this population. Vertebral axial loading walking training is a novel and functional intervention that applies gentle vertical loading along the spinal axis during slow and controlled walking. Axial loading is thought to stimulate spinal mechanoreceptors and enhance sensory feedback, thereby facilitating improved proprioceptive awareness, postural stability, and motor coordination during functional activities. This approach is practical, cost-effective, and easily integrated into rehabilitation settings. In this randomized controlled study, participants with chronic low back pain will be allocated to either a core stabilization exercise program alone or a combined intervention consisting of core stabilization exercises and vertebral axial loading walking training. Outcome measures will include pain intensity, balance performance, lumbar proprioception, trunk muscle strength and endurance, and body awareness. Assessments will be conducted at baseline and after the intervention period. The results of this study are expected to provide evidence for a more comprehensive rehabilitation strategy by integrating sensory-based and functional axial loading approaches into physiotherapy programs for individuals with chronic low back pain.

Being tested
Exercise - Core Stabilization Exercise Program, Core Stabilization Exercises Plus Vertebral Axial Loading Walking Training
Keywords
Chronic Low Back Pain, Core Stabilization Exercise, Spinal Stabilization, Proprioception, Sensorimotor Control, Physiotherapy Rehabilitation, Neuromuscular Control, Vertebral Axial Loading, Balance, Trunk Muscle Strength, Trunk Muscle Endurance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise - Core Stabilization Exercise ProgramBehavioural

    Participants receive a physiotherapist-supervised core stabilization exercise program applied three sessions per week for six weeks. Before training, participants are educated about core muscle function and taught the abdominal bracing maneuver. Exercises are performed with neutral spinal alignment and controlled diaphragmatic breathing. Each session includes warm-up and cool-down exercises. The program consists of deep abdominal muscle activation, lower extremity movements with maintained trunk stability, bridging exercises, modified curl-up, and quadruped stabilization exercises. Exercises are demonstrated by the physiotherapist, performed with progressive repetitions, and corrected using verbal and manual feedback. The training is supervised by a physiotherapist and applied three sessions per week for six weeks.

  • Core Stabilization Exercises Plus Vertebral Axial Loading Walking TrainingBehavioural

    Participants receive the same core stabilization exercise program combined with vertebral axial loading proprioceptive walking training. Axial loading is applied through the vertex of the head using external weights ranging from 50 to 250 grams, adjusted according to individual tolerance. Walking is performed at a constant slow pace using a metronome set at 72 beats per minute. The initial walking distance is 40 meters and is progressively increased by 20 meters per week, reaching up to 140 meters. The intervention is supervised by a physiotherapist and applied three sessions per week for six weeks.

Study groups in NCT07334782
Study groupRoleWhat they receive
Core Stabilization Exercises plus Vertebral Axial Loading Walking Training (CSE+ALWT Group)ExperimentalParticipants in this group receive a standardized core stabilization exercise program combined with vertebral axial loading proprioceptive walking training. The intervention is supervised by a physiotherapist and applied three sessions per week for six weeks.
Receives: Behavioral: Core Stabilization Exercises Plus Vertebral Axial Loading Walking Training
Core Stabilization Exercises Only (CSE Group)Active comparatorParticipants in this group receive the standardized core stabilization exercise program alone, supervised by a physiotherapist, three sessions per week for six weeks.
Receives: Behavioral: Exercise - Core Stabilization Exercise Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Lumbar Proprioception (Active Joint Position Sense) After 6 Weeks of Intervention

    Lumbar proprioception will be assessed by measuring active joint position sense during trunk flexion, lateral flexion, and extension using MATLAB-based angle analysis. The absolute angular error (in degrees) between the target position and the reproduced position will be calculated. Angular error is recorded in degrees, starting from 0° upward. Lower values indicate better proprioceptive accuracy. Higher values indicate impaired proprioception.

    Measured: Baseline and 6 weeks

  2. Change from Baseline in Pain Intensity at Rest and During Activity After 6 Weeks

    Pain intensity will be assessed using the Numeric Rating Scale (NRS). The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Lower scores indicate less pain.

    Measured: Baseline and 6 weeks

  3. Change from Baseline in Lumbar Pressure Pain Threshold After 6 Weeks

    Pressure pain threshold will be measured using a handheld algometer (Algometer commander, JTech Medical) and recorded in kg/cm². Higher values indicate greater pain tolerance, while lower values indicate increased pain sensitivity.

    Measured: Baseline and 6 weeks

  4. Change from Baseline in Trunk and Hip Muscle Strength After 6 Weeks

    Isometric muscle strength of trunk and hip muscles will be assessed using a digital hand-held dynamometer (Lafeyette Instrument®, Lafayette, IN) during maximal voluntary isometric contraction. Strength values are recorded in Newtons (N) or kilograms (kg). Higher values indicate greater muscle strength

    Measured: Baseline and 6 weeks

Secondary outcomes (8)
  1. Change from Baseline in Balance Performance Assessed by the Fullerton Advanced Balance Test After 6 Weeks

    Balance performance will be assessed using the Fullerton Advanced Balance Test (FAB-T), consisting of 10 functional balance tasks. Total scores range from 0 to 40. Higher scores indicate better balance performance. Scores ≤25 indicate increased risk of falls.

    Measured: Baseline and 6 weeks

  2. Change from Baseline in Functional Disability Assessed by the Oswestry Disability Index After 6 Weeks

    Functional disability related to low back pain will be assessed using the Oswestry Disability Index (ODI), version 2.1a.

    Scores range from 0% to 100%, where:

    0% = no disability 100% = maximum disability Higher scores indicate greater disability.

    Measured: Baseline and 6 weeks

  3. Change from Baseline in Postural Alignment Assessed by the New York Posture Rating Scale After 6 Weeks

    Postural alignment will be evaluated using the New York Posture Rating Scale (NYPRS) based on observational assessment of body segments. Scores range from 0 to 100. Higher scores indicate better postural alignment.

    Measured: Baseline and 6 weeks

  4. Change from Baseline in Kinesiophobia Assessed by the Tampa Scale of Kinesiophobia After 6 Weeks

    Fear of movement will be assessed using the Tampa Scale of Kinesiophobia (TSK). Total scores range from 17 to 68, with higher scores indicating greater fear of movement. Scores above 37 indicate high levels of kinesiophobia.

    Measured: Baseline and 6 weeks

  5. Change from Baseline in Health-Related Quality of Life Assessed by the EQ-5D-5L After 6 Weeks

    Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) and the EQ Visual Analogue Scale (EQ-VAS). The EQ-VAS ranges from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. Higher scores indicate better perceived health-related quality of life.

    Measured: Baseline and 6 weeks

  6. Change from Baseline in Lumbar Range of Motion After 6 Weeks

    Lumbar range of motion was assessed using a 360-degree universal goniometer, which is designed to measure joint position and range of motion across nearly all body joints. The goniometer used in this study was a plastic, full-circle (360°) universal goniometer, allowing continuous angular measurement throughout the full range of motion. Lumbar movements including trunk flexion, extension, right lateral flexion, and left lateral flexion were measured in degrees following standardized assessment procedures. Higher angle values indicate greater lumbar mobility, whereas lower values indicate reduced range of motion.

    Measured: Baseline and 6 weeks

  7. Change from Baseline in Trunk Muscle Endurance After 6 Weeks

    Trunk muscle endurance will be assessed using the Biering-Sorensen Test for trunk extensor muscles and the Kraus-Weber Test for trunk flexor muscles. Participants will be instructed to maintain the standardized test position for as long as possible, and endurance time will be recorded in seconds, with a maximum duration of 240 seconds. Longer holding times indicate greater trunk muscle endurance.

    Measured: Baseline and 6 weeks

  8. Change from Baseline in Trunk Sensory Function After 6 Weeks

    Trunk sensory function will be assessed at the L1, L3, and L5 levels using a standardized sensory test battery including light touch sensation, vibration sense, two-point discrimination, and graphesthesia. Light touch sensation will be evaluated using Semmes-Weinstein monofilaments, vibration sense using a 128-Hz tuning fork, two-point discrimination using an aesthesiometer, and graphesthesia by letter recognition tasks applied to the skin. Sensory outcomes will be quantified as tactile threshold (g/mm²), vibration perception time (seconds), minimal two-point discrimination distance (millimeters), and graphesthesia accuracy score, respectively. Lower tactile thresholds, longer vibration perception times, smaller discrimination distances, and higher graphesthesia accuracy indicate better sensory function.

    Measured: Baseline and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2026
  2. Study start19 Jan 2026
  3. Primary completion25 Apr 2026 (estimated)
  4. Study completion15 Jul 2026 (estimated)

Resources

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
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07334782
Sponsor's protocol ID
FTREK24/69
Status last verified
Jan 2026
First submitted
31 Dec 2025
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared due to ethical and privacy considerations and because the study is conducted as part of a graduate thesis. Aggregated data may be reported in publications.

Publications

  • Suh JH, Kim H, Jung GP, Ko JY, Ryu JS. The effect of lumbar stabilization and walking exercises on chronic low back pain: A randomized controlled trial. Medicine (Baltimore). 2019 Jun;98(26):e16173. doi: 10.1097/MD.0000000000016173.

    PubMed 31261549
  • Hlaing SS, Puntumetakul R, Khine EE, Boucaut R. Effects of core stabilization exercise and strengthening exercise on proprioception, balance, muscle thickness and pain related outcomes in patients with subacute nonspecific low back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2021 Nov 30;22(1):998. doi: 10.1186/s12891-021-04858-6.

    PubMed 34847915
  • Bento TPF, Genebra CVDS, Maciel NM, Cornelio GP, Simeao SFAP, Vitta A. Low back pain and some associated factors: is there any difference between genders? Braz J Phys Ther. 2020 Jan-Feb;24(1):79-87. doi: 10.1016/j.bjpt.2019.01.012. Epub 2019 Feb 13.

    PubMed 30782429
  • Delitto A, George SZ, Van Dillen L, Whitman JM, Sowa G, Shekelle P, Denninger TR, Godges JJ; Orthopaedic Section of the American Physical Therapy Association. Low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):A1-57. doi: 10.2519/jospt.2012.42.4.A1. Epub 2012 Mar 30.

    PubMed 22466247
  • Classification of chronic pain. Descriptions of chronic pain syndromes and definitions of pain terms. Prepared by the International Association for the Study of Pain, Subcommittee on Taxonomy. Pain Suppl. 1986;3:S1-226. No abstract available.

    PubMed 3461421

Questions about this trial

What is this clinical trial studying?

A study testing Exercise - Core Stabilization Exercise Program and Core Stabilization Exercises Plus Vertebral Axial Loading Walking Training in people with Chronic Low-back Pain (cLBP), run by Hacettepe 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 16 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: under way, not looking for participants, as of the sponsor's last update on 2 Feb 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

Change from Baseline in Lumbar Proprioception (Active Joint Position Sense) After 6 Weeks of Intervention (time frame: Baseline and 6 weeks). The study lists 4 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 NCT07334782, which also lists 5 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 2 Feb 2026.

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