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CompletedNCT04602793Updated Oct 26, 2020

Sonographic Evaluation Of Nerve Thickness In Traumatic Lower-Limb Amputees

An observational study in Amputation, Traumatic, sponsored by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-26.

Sponsored by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
33
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the detailed description

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.

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Conditions studied

  • Amputation, Traumatic

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Keywords

  • Amputation
  • Prosthesis
  • peripheral nerves
  • ultrasonography
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In context

Amputation, Traumatic

101 studies on the registry are indexed under Amputation, Traumatic; 14 are open to participants now.

This study's enrollment of 33 is close to the median of 34 across 30 observational studies indexed under Amputation, Traumatic.

Browse Amputation, Traumatic studies →

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital is the lead sponsor of 80 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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...)
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Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
33 participants (actual)
Target follow-up
1 Year
Patient registry
Yes

Interventions

  • Diagnostic testultrasonography

    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.

06

What researchers measure

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.

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

Secondary outcomes

  1. Visual analog scale (VAS)

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

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

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

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

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

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Study locations

1 site
  • Gaziler PMR, Training and Research Hospital, Department of PMR
    Ankara, Çankaya/turkey 06100, Turkey
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04602793
Lead sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Responsible party
Sefa Gümrük Aslan (Sonographic Evaluation Of Nerve Thickness In Traumatic Lower-Limb Amputees: a Clinical and Sonographic-controlled Study, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital) — Principal investigator
First posted
Oct 26, 2020
Start date
Apr 1, 2019
Primary completion
Apr 1, 2020
Completion
Apr 1, 2020
Last update
Oct 26, 2020

Study contacts

sefa Gümrük Aslan, MD
principal investigator · Gaziler PMR, Training and Research Hospital, Department of PMR

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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