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

NCT07532642 | Recruiting DMC

• 1 other identifier: Refª. Nº 282/21
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postural Neck Pain; Postural Imbalance; Postural Disorders

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Radiographic modification of cervical lordosis

  From enrollment to second radiographic evaluation at day 1

• Radiographic modification of inclination of C1

  From enrollment to second radiographic evaluation at day 1

• Radiographic modification of inclination of C2

  From enrollment to second radiographic evaluation at day 1

• Radiographic modification of global spinal vertical alignment

  From enrollment to second radiographic evaluation at day 1

Study Arms (1)

Unique

EXPERIMENTAL

Device: Prismatic low-powered lenses

Interventions

Prismatic low-powered lenses DEVICE

Participants perform biplanar X-ray before and after lens application

Unique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

CAML

Lisbon, Lisbon District, Portugal

RECRUITING

Central Study Contacts

João Alves da Silva, MD

CONTACT

+351935457064; joao-luis@edu.ulisboa.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 16, 2026
• Study Start: March 27, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations

PT (1)