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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLisbon Academic Medical Center - Centro Académico de Medicina de Lisboa

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Prismatic low-powered lenses

    Device

    Participants perform biplanar X-ray before and after lens application

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: UniqueExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to second radiographic evaluation on day 1
2

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.

Time frame
From enrollment to second radiographic evaluation at day 1
3

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.

Time frame
From enrollment to second radiographic evaluation at day 1

Secondary outcomes

1

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).

Time frame
From enrollment to second radiographic evaluation at day 1
2

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).

Time frame
From enrollment to second radiographic evaluation at day 1
3

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).

Time frame
From enrollment to second radiographic evaluation at day 1
4

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).

Time frame
From enrollment to second radiographic evaluation at day 1

Other outcomes

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