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NCT Number: NCT07532642

Radiographic Head and Neck Positional Changes in Response to Usage of Low-powered Prismatic Lenses

This study aims to investigate the short-term modifications in head and neck positioning by usage of low-powered prismatic lenses in patients with Postural Deficiency Syndrome (PDS). A matched pair observation study was designed. Evaluation is carried out using low dose biplanar radiography before treatment and 15 minutes after lenses application.

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Key information

Conditions

Postural Neck Pain Postural Disorders Postural Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CAML

Lisbon, Lisbon District, Portugal

Location status: Recruiting

Location contact

Fábio Trindade, PhD

SUB_INVESTIGATOR

Ivo Álvares Furtado, PhD

SUB_INVESTIGATOR

João Alves da Silva, MD

CONTACT

[email protected]

+351935457064

João Alves da Silva, MD

PRINCIPAL_INVESTIGATOR

Pedro Fernandes, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Presentation of diagnostic criteria for Postural Deficiency Syndrome comprising of

  • Two or more cardinal signs of Postural Deficiency Syndrome
  • Clinical presentation of asymmetrical stance and head extension and rotation
  • Presence of typical directional pseudoscotoma described in this syndrome

Exclusion criteria

  • Vision under 8/10, strabismus or nistagmus;
  • Previous eye or vestibular surgery;
  • Known disease affecting the central nervous system or inner ear;
  • Medication with known interference with balance and posture and
  • treatment for postural and movement disorders in the previous year.

Treatment and study plan

Prismatic low-powered lenses

Device

Participants perform biplanar X-ray before and after lens application

Primary outcomes

  1. Radiographic modification of pelvic tilt angle

    Time frame: From enrollment to second radiographic evaluation on day 1

    Changes in pelvic tilt angle are measured between two subsequent radiographic biplanar scans in standing position, before and after lenses application on the same patient. Measurement is performed in degrees using the radiographic equipment proprietary software (EOS imaging). A minimum clinical significance value of 3 degrees was estimated.

  2. Radiographic modification of C0 inclination

    Time frame: From enrollment to second radiographic evaluation at day 1

    Changes in C0 inclination angle are measured between two subsequent radiographic biplanar scans in standing position, before and after lenses application on the same patient. Measurement is performed in degrees using the radiographic equipment proprietary software (EOS imaging). A minimum clinical significance value of 3 degrees was estimated.

  3. Radiographic modification of cervical spinal vertical alignment

    Time frame: From enrollment to second radiographic evaluation at day 1

    Changes of cervical spinal vertical alignment are measured between two subsequent radiographic biplanar scans in standing position, before and after lenses application on the same patient. Measurement is performed in millimeters using the radiographic equipment proprietary software (EOS imaging). A minimum clinical significance value of 2 millimeters was estimated.

Secondary outcomes

  1. Radiographic modification of cervical lordosis

    Time frame: From enrollment to second radiographic evaluation at day 1

    Changes of cervical lordosis angle are measured between two subsequent radiographic biplanar scans in standing position, before and after lenses application on the same patient. Measurement is performed in degrees using the radiographic equipment proprietary software (EOS imaging).

  2. Radiographic modification of inclination of C1

    Time frame: From enrollment to second radiographic evaluation at day 1

    Changes of C1 inclination angle are measured between two subsequent radiographic biplanar scans in standing position, before and after lenses application on the same patient. Measurement is performed in degrees using the radiographic equipment proprietary software (EOS imaging).

  3. Radiographic modification of inclination of C2

    Time frame: From enrollment to second radiographic evaluation at day 1

    Changes of C2 inclination angle are measured between two subsequent radiographic biplanar scans in standing position, before and after lenses application on the same patient. Measurement is performed in degrees using the radiographic equipment proprietary software (EOS imaging).

  4. Radiographic modification of global spinal vertical alignment

    Time frame: From enrollment to second radiographic evaluation at day 1

    Changes of global spinal vertical alignment are measured between two subsequent radiographic biplanar scans in standing position, before and after lenses application on the same patient. Measurement is performed in millimeters using the radiographic equipment proprietary software (EOS imaging).

Study contacts

Contact information is provided by the study sponsor or research team.

João Alves da Silva, MD

CONTACT

[email protected]

+351935457064

Sponsors and collaborators

Lead sponsor

Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa

Network

Registry information

Official study title

Radiographic Head and Neck Positional Changes in Response to Oculomotor Muscles Tonic Modification Using Low-powered Prismatic Lenses

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2026
Registry last updated
Apr 16, 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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