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

Radiographic Head and Neck Positional Changes in Response to Oculomotor Muscles Tonic Modification Using 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.

Study Overview

• Status: Recruiting
• Conditions: Postural Imbalance; Postural Neck Pain; Postural Disorders
• Intervention / Treatment: Device: Prismatic low-powered lenses

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: João Alves da Silva, MD; Phone Number: +351935457064; Email: joao-luis@edu.ulisboa.pt

Study Locations

• Portugal
  • Lisbon District
    • Lisbon, Lisbon District, Portugal
      • Recruiting
      • CAML
      • Contact: João Alves da Silva, MD; Phone Number: +351935457064; Email: joao-luis@edu.ulisboa.pt
      • Principal Investigator: João Alves da Silva, MD
      • Sub-Investigator: Pedro Fernandes, PhD
      • Sub-Investigator: Ivo Álvares Furtado, PhD
      • Sub-Investigator: Fábio Trindade, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unique	Device: Prismatic low-powered lenses; Participants perform biplanar X-ray before and after lens application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic modification of pelvic tilt angle	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.	From enrollment to second radiographic evaluation on day 1
Radiographic modification of C0 inclination	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.	From enrollment to second radiographic evaluation at day 1
Radiographic modification of cervical spinal vertical alignment	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.	From enrollment to second radiographic evaluation at day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic modification of cervical lordosis	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).	From enrollment to second radiographic evaluation at day 1
Radiographic modification of inclination of C1	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).	From enrollment to second radiographic evaluation at day 1
Radiographic modification of inclination of C2	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).	From enrollment to second radiographic evaluation at day 1
Radiographic modification of global spinal vertical alignment	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).	From enrollment to second radiographic evaluation at day 1

Collaborators and Investigators

• Sponsor: Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: April 6, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Refª. Nº 282/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All measurements performed from imaging studies
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No