- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07334782
Effects of Vertebral Axial Loading Walking Combined With Core Stabilization Exercises in Individuals With Chronic Low Back Pain (ALWT-CLBP)
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey (Türkiye), 06100
- Hacettepe University, Faculty of Physical Therapy and Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Receipt of physical therapy or rehabilitation within the past 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Core Stabilization Exercises plus Vertebral Axial Loading Walking Training (CSE+ALWT Group)
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.
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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.
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Active Comparator: Core Stabilization Exercises Only (CSE Group)
Participants in this group receive the standardized core stabilization exercise program alone, supervised by a physiotherapist, three sessions per week for six weeks.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change from Baseline in Lumbar Proprioception (Active Joint Position Sense) After 6 Weeks of Intervention
Time Frame: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline in Pain Intensity at Rest and During Activity After 6 Weeks
Time Frame: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline in Lumbar Pressure Pain Threshold After 6 Weeks
Time Frame: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline in Trunk and Hip Muscle Strength After 6 Weeks
Time Frame: Baseline and 6 weeks
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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
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Baseline and 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change from Baseline in Balance Performance Assessed by the Fullerton Advanced Balance Test After 6 Weeks
Time Frame: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline in Functional Disability Assessed by the Oswestry Disability Index After 6 Weeks
Time Frame: Baseline and 6 weeks
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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. |
Baseline and 6 weeks
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Change from Baseline in Postural Alignment Assessed by the New York Posture Rating Scale After 6 Weeks
Time Frame: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline in Kinesiophobia Assessed by the Tampa Scale of Kinesiophobia After 6 Weeks
Time Frame: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline in Health-Related Quality of Life Assessed by the EQ-5D-5L After 6 Weeks
Time Frame: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline in Lumbar Range of Motion After 6 Weeks
Time Frame: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline in Trunk Muscle Endurance After 6 Weeks
Time Frame: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change from Baseline in Trunk Sensory Function After 6 Weeks
Time Frame: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FTREK24/69
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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