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NCT Number: NCT07559539

Functional Limitations, Body Structure and Function Impairments, and Quality of Life in Adults After Surgical Treatment of Adolescent Idiopathic Scoliosis

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity, and a subset of patients undergo surgical correction during adolescence, most commonly posterior spinal fusion (PSF). Although surgical treatment improves deformity and quality of life in the short and mid-term, its long-term impact on functional status in adulthood remains insufficiently understood.

This cross-sectional study aims to evaluate long-term outcomes in adults aged 25-40 years who underwent surgical treatment for AIS, compared with non-operated individuals with scoliosis and healthy controls. The study will assess limitations in daily functioning, musculoskeletal and respiratory function, pain, and compensatory mechanisms using standardized clinical measurements and questionnaires.

The findings are expected to provide insight into long-term functional consequences of AIS and support the development of targeted physiotherapy and preventive strategies for adults treated for scoliosis during adolescence.

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Key information

About this study

Adolescent idiopathic scoliosis (AIS) is a structural spinal deformity associated with long-term alterations in musculoskeletal function, posture, and respiratory mechanics. In progressive cases, surgical correction using posterior spinal fusion (PSF) is performed during adolescence; however, long-term functional outcomes remain insufficiently characterized.

This observational, cross-sectional study compares adults with surgically treated AIS, conservatively treated AIS, and healthy controls. Participants will undergo a standardized assessment protocol including anthropometric measurements, clinical examination, and patient-reported outcomes.

Anthropometric assessment will include body height, sitting height, body mass, arm span, waist and hip circumference, lower limb length and asymmetry, and chest circumference at rest and maximal inspiration, with derived indices of body proportions.

Functional status will be assessed using an author-developed questionnaire based on the International Classification of Functioning, Disability and Health (ICF), capturing perceived limitations in body functions, activities, participation, and environmental factors.

Clinical evaluation will include assessment of spinal curvature and pelvic alignment using inclinometric and scoliometric methods, as well as range of motion (ROM) of the cervical spine, temporomandibular joint, and peripheral joints. Additional orthopedic functional tests will be performed to assess lumbopelvic and lower limb function.

Pain will be evaluated using validated scales and graphical mapping of pain distribution.

Respiratory assessment will include spirometry and flow-volume measurements conducted according to international standards, chest wall mobility assessment, and measurement of respiratory muscle strength (maximal inspiratory and expiratory pressures). In addition, diaphragm structure and function will be evaluated using ultrasound imaging. Measurements will include diaphragm thickness and thickening fraction during respiratory cycles, as well as diaphragmatic excursion during quiet and deep breathing, performed under standardized conditions. This assessment aims to provide an objective evaluation of diaphragmatic mechanics, which may be altered in individuals with thoracic deformity or after surgical stabilization of the spine.

Exploratory analyses will examine associations between clinical variables and functional outcomes. The study aims to provide a comprehensive characterization of long-term functional status and inform targeted rehabilitation strategies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female, age 25-40
  • AIS diagnosed before age 18 (Cobb angle >35°)
  • Operated group: PSF, 10-25 years post-surgery
  • Informed consent

Exclusion criteria

  • Surgery other than PSF
  • Surgery performed in adulthood

Treatment and study plan

Primary outcomes

  1. ICF-Based Functional Limitations Questionnaire Total Score

    Time frame: Baseline assessment, single study visit

    Author-developed questionnaire based on the International Classification of Functioning, Disability and Health (ICF), assessing body functions, activities, participation, and environmental factors. Higher total scores indicate greater disability.

Secondary outcomes

  1. SRS-22 Total Score

    Time frame: Baseline assessment, single study visit

    Quality of life assessed using the Scoliosis Research Society-22 questionnaire. The questionnaire contains 22 items across five domains (function/activity, pain, self-image/appearance, mental health, and satisfaction with management), each scored from 1 to 5. Mean domain scores and the total mean score range from 1 to 5, with higher scores indicating better function and higher quality of life.

  2. Pain Intensity by Visual Analog Scale (VAS)

    Time frame: Baseline assessment, single study visit

    Pain severity assessed on a 0 to 10 scale. Higher scores indicate greater pain intensity.

  3. Forced Vital Capacity (FVC % Predicted)

    Time frame: Baseline assessment, single study visit

    Pulmonary function assessed by spirometry. Higher values indicate better respiratory function.

  4. Forced Expiratory Volume in 1 Second (FEV1 % Predicted)

    Time frame: Baseline assessment, single study visit

    Spirometry measure of expiratory volume in one second. Higher values indicate better pulmonary function.

  5. Angle of Trunk Rotation

    Time frame: Baseline assessment, single study visit

    Measured using Bunnell scoliometer, reported in degrees.

  6. Thoracic Kyphosis Angle

    Time frame: Baseline assessment, single study visit

    Measured using inclinometer/plurimeter, reported in degrees.

  7. Lumbar Lordosis Angle

    Time frame: Baseline assessment, single study visit

    Measured using inclinometer/plurimeter, reported in degrees.

Other outcomes

  1. Chest Expansion

    Time frame: Baseline assessment, single study visit

    Difference between maximal inhalation and exhalation chest circumference, reported in centimeters.

  2. Cervical Rotation Range of Motion

    Time frame: Baseline assessment, single study visit

    Passive cervical rotation measured in degrees.

  3. Peripheral Joint Range of Motion

    Time frame: Baseline assessment, single study visit

    Shoulder, hip, knee, and ankle range of motion measured in degrees.

  4. Limb Length Discrepancy

    Time frame: Baseline assessment, single study visit

    Difference between lower limb lengths, reported in centimeters.

  5. Waist-to-Height Ratio (WHtR)

    Time frame: Baseline assessment, single study visit

    Calculated from waist circumference and height.

  6. Maximum Mouth Opening

    Time frame: Baseline assessment, single study visit

    Mandibular abduction measured in centimeters.

Sponsors and collaborators

Lead sponsor

Józef Piłsudski University of Physical Education

Other

Registry information

Official study title

Functional Limitations, Body Structure and Function Impairments, and Quality of Life in Adults After Surgical Treatment of Adolescent Idiopathic Scoliosis With Comparison to Non-Operatively Treated and Non-Scoliotic Individuals

Acronym: AIS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 30, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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