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Ultrasonography in Diagnosis of Polyneuropathy

Optimization of Ultrasound Sheer Wave Elastography for the Evaluation of Peripheral Nerve Disorders

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06390527
Enrollment
120
Registered
2024-04-30
Start date
2024-06-01
Completion date
2027-02-01
Last updated
2024-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polyneuropathies

Brief summary

The main goal of this trial is to establish recommendations for clinical practice that enhance the reliability, accessibility and convenience of sheer wave elastography as a routine diagnostic test for diverse peripheral neuropathies.

Interventions

None listed

Sponsors

University of Ljubljana, Faculty of Medicine
CollaboratorOTHER
University Medical Centre Ljubljana
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Age 18-80 years * Clinical signs of particular polyneuropathy not explained by other causes

Exclusion criteria

* Entrapment or compression neuropathies * Nerve trauma * The diagnosis of vasculitic neuropathy, neuralgic amyotrophy, diabetic radiculo-plexo-neuropathy, hereditary neuropathy with liability to pressure palsies and motor neuron disorders including monomelic amyotrophy.

Design outcomes

Primary

MeasureTime frameDescription
Clinical examinationThrough study completion, an average 2 years.1\) Myotatic reflexes (biceps, triceps, finger flexors, patellar, Achilles, deep abdominal): 1-absent, 2-reduced or 3-present with facilitation. 1. Muscle atrophy: 1-no atrophy, 2-mild, 3-moderate or4-severe atrophy 2. Muscle strength of lower and upper limbs with Medical Research Council (MRC) scale (0-5/5): shoulder abduction, elbow flexion and extension, wrist flexion and extension, fingers flexion, extension and abduction, hip flexion, extension, abduction and adduction, knee flexion and extension, ankle dorsal flexion, plantar flexion, eversion and inversion, thumb flexion and extension. 3. Touch sensation in all dermatomes with cotton wool: 1-normal sensation, 2-mild, 3-severe or 4-absent.
Electrodiagnostic studiesThrough study completion, an average 2 years.1. Motor nerve conduction studies in median, ulnar, radial, fibular and tibial: distal motor latency, compound muscle action potential (CMAP) amplitude, duration and area, conduction velocity. 2. Sensory nerve conduction studies in median, ulnar, superficial radial, superficial fibular and sural nerve: latency, sensory nerve action potential (SNAP) amplitude and velocity
UltrasonographyThrough study completion, an average 2 years.Cross-sectional area (CSA) and shear-wave velocity (SV) of: 1. median nerve at wrist, forearm, elbow and upper arm 2. ulnar nerve at wrist, forearm, elbow and upper arm 3. radial nerve at elbow and upper arm 4. vagus nerve 5. brachial plexus (C5,6 and 7) 6. fibular nerve at capitulum fibulae and popliteal fossa 7. tibial nerve at the medial malleolus and popliteal fossa 8. sciatic nerve 9. sural nerve
Patient historyThrough study completion, an average 2 years.1. demographic data: sex, date of birth, height, weight 2. symptoms duration (months), symptoms, therapy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026