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Completed

NCT Number: NCT04602793

Sonographic Evaluation Of Nerve Thickness In Traumatic Lower-Limb Amputees

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gaziler PMR, Training and Research Hospital, Department of PMR

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

About this study

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. The study was conducted between April 2019 and April 2020. Participants were totally volunteers and informed about the nature of the study. Written informed consent was obtained prior to assessment from all individuals. The study was conducted by the latest version of the principles of the Declaration of Helsinki protocol. All procedures were in consistency with the Helsinki Declarations of 1975. The study was approved by the local ethical committee.

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.

Demographic and clinical characteristics of the participants including age, gender, amputation findings (etiology, time since amputation, level, and side), prosthesis use findings (time since prosthesis use, daily use time, type, type of liner, prosthetic foot type), and functional K level of activity after amputation were recorded.

The presence, etiology, and duration of pain were questioned, and the intensity of pain was assessed by visual analog scale (VAS). Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) was used to evaluate neuropathic pain for the residual limb. The patient's satisfaction with the current prosthesis was evaluated numerically between 0 (not satisfied at all) and 10 (completely satisfied).

All ultrasonographic examinations were performed by a single physiatrist experienced in musculoskeletal sonography. A 5-12 MHz linear transducer (Logic e portable; GE Healthcare, China) was used. To optimize image quality, minimal pressure was applied to the transducer. Each examination was performed bilaterally while patients were in the prone position. 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 (Figure 1), 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. The presence of a neuroma was also evaluated throughout the nerve, particularly at the distal ends.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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...)

Treatment and study plan

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.

Primary outcomes

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

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

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

Secondary outcomes

  1. Visual analog scale (VAS)

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

    The Visual analog scale (VAS) will be used for the assessment of the intensity of pain

  2. Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)

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

    The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) will be used to evaluate neuropathic pain for the residual limb.

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Official study title

Sonographic Evaluation Of Nerve Thickness In Traumatic Lower-Limb Amputees: a Clinical and Sonographic-controlled Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 26, 2020
Registry last updated
Oct 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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