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

NCT07334782 | Active Not Recruiting

• 1 other identifier: FTREK24/69
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Low-back Pain (cLBP)

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

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline and 6 weeks

• 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.

  Baseline and 6 weeks

• 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.

  Baseline and 6 weeks

• 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

  Baseline and 6 weeks

Secondary Outcomes (8)

• Change from Baseline in Balance Performance Assessed by the Fullerton Advanced Balance Test After 6 Weeks

  Baseline and 6 weeks

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

  Baseline and 6 weeks

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

  Baseline and 6 weeks

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

  Baseline and 6 weeks

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

  Baseline and 6 weeks

Study Arms (2)

Core Stabilization Exercises plus Vertebral Axial Loading Walking Training (CSE+ALWT Group)

EXPERIMENTAL

Participants 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.

Behavioral: Core Stabilization Exercises Plus Vertebral Axial Loading Walking Training

Core Stabilization Exercises Only (CSE Group)

ACTIVE COMPARATOR

Participants in this group receive the standardized core stabilization exercise program alone, supervised by a physiotherapist, three sessions per week for six weeks.

Behavioral: Exercise - Core Stabilization Exercise Program

Interventions

Exercise - Core Stabilization Exercise Program BEHAVIORAL

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 Only (CSE Group)

Core Stabilization Exercises Plus Vertebral Axial Loading Walking Training BEHAVIORAL

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.

Core Stabilization Exercises plus Vertebral Axial Loading Walking Training (CSE+ALWT Group)

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 31261549 BACKGROUND

• 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.

  PMID: 34847915 BACKGROUND

• 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.

  PMID: 30782429 BACKGROUND

• 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.

  PMID: 22466247 BACKGROUND

• 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.

  PMID: 3461421 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 12, 2026
• Study Start: January 19, 2026
• Primary Completion: April 25, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)