Sonographic Evaluation Of Nerve Thickness In Traumatic Lower-Limb Amputees

NCT04602793 | Completed

• 1 other identifier: 6
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Lower limb amputation (LLA) commonly affects young and active people who have long life expectancy. It is a major surgery causing many functional deficiencies which can reduce overall health quality and physical condition of the wounded persons and necessitating a multidisciplinary rehabilitation programme. High-frequency ultrasonography (US) is useful in evaluating peripheral nerves because of it has many superiority to other techniques. The advantages of US is; it has high resolution but no ionized radiation. It is possible to make dynamic and real-time imaging. It was showed that US have the same specificity and more sensitivity than magnetic resonance (MR) imaging in evaluating peripheral nerves. The aim of this study is to evaluate the sciatic, tibial and peroneal nerves of traumatic lower-limb amputees with the help of sonography and find the relationship between sonographic values and clinical characteristics.

Conditions

Amputation, Traumatic

Keywords

Amputation; Prosthesis; peripheral nerves; ultrasonography

Outcome Measures

Primary Outcomes (1)

• Sciatic nerve (SN), tibial nerve (TN), and common peroneal nerve (CPN) thickness measurements

  Sciatic nerve (SN), tibial nerve (TN), and common peroneal nerve (CPN) thickness and cross sectional area measurements will be performed by using ultrasound.

  through study completion, an average of one and a half months]

Secondary Outcomes (2)

• Visual analog scale (VAS)

  through study completion, an average of one and a half months

• Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)

  through study completion, an average of one and a half months

Interventions

ultrasonography DIAGNOSTIC_TEST

All ultrasonographic examinations were performed by a single physiatrist experienced in musculoskeletal sonography. The full course of the sciatic nerve (SN), tibial nerve (TN), and common peroneal nerve (CPN) was assessed in a craniocaudal direction starting from the subgluteal fold to the popliteal fossa. The probe was placed axially on the nerves (perpendicular to the nerve) and the cross-sectional area (CSA) was measured at the same level proximal to the bifurcation for the SN , and at a point distal to the bifurcation of the SN for the TN and CPN (Figure 2). The values from the normal sides were accepted as controls.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of thirty-three participants (age range 18-65) who had lower extremity amputation due to traumatic injury and were followed up in tertiary amputee clinic were included in this cross-sectional trial. All patients had completed stump healing. Patients with any disease affecting the peripheral nerves (eg, diabetes mellitus, infections, metabolic problems, inherited causes, and exposure to toxins) were excluded.

You may qualify if:

• Patients between the ages of 18-65
• Patients who have been followed up for at least 3 months with the diagnosis of unilateral transtibial amputation
• Patients who have been using prostheses for at least 3 months

You may not qualify if:

• Bilateral amputation
• Previous history of any trauma/surgical history of the lower extremities (other than amputation)
• Rheumatic diseases
• Contracture of the knee and the ankle of the intact limb .Presence of comorbid diseases that may cause peripheral nerve lesions ( e.g diabetis mellitus, using alcohol, thyroid diseases...)

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Gaziler PMR, Training and Research Hospital, Department of PMR

Ankara, Çankaya/turkey, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Amputation, Traumatic

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• sefa Gümrük Aslan, MD

  Gaziler PMR, Training and Research Hospital, Department of PMR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sonographic Evaluation Of Nerve Thickness In Traumatic Lower-Limb Amputees: a Clinical and Sonographic-controlled Study

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 26, 2020
• Study Start: April 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: October 26, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)