Amputation, TraumaticNCT04602793
Sonographic Evaluation Of Nerve Thickness In Traumatic Lower-Limb Amputees
An observational study of Amputation, Traumatic, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation, Traumatic
- What is being tested?
- ultrasonography
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 1 Apr 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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...)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziler PMR, Training and Research Hospital, Department of PMR
Ankara, Çankaya/turkey, 06100
About this study
Official title: Sonographic Evaluation Of Nerve Thickness In Traumatic Lower-Limb Amputees: a Clinical and Sonographic-controlled Study
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.
- Conditions
- Amputation, Traumatic
- Being tested
- ultrasonography
- Keywords
- Amputation, Prosthesis, peripheral nerves, ultrasonography
- Medical subject headings
- Amputation, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographyDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of one and a half months]
Secondary outcomes (2)
Visual analog scale (VAS)
The Visual analog scale (VAS) will be used for the assessment of the intensity of pain
Measured: through study completion, an average of one and a half months
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.
Measured: through study completion, an average of one and a half months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start1 Apr 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation, TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sefa Gümrük Aslan, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- sefa Gümrük Aslan, MD, Principal investigator, Gaziler PMR, Training and Research Hospital, Department of PMR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602793
- Sponsor's protocol ID
- 6
- Status last verified
- Oct 2020
- First submitted
- 21 Oct 2020
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Evaluation Of Nerve Thickness In Traumatic Lower-Limb Amputees: a Clinical and Sonographic-controlled Study
- ClinicalTrials.gov ID
- NCT04602793
- Acronym / sponsor ID
- 6
- Conditions
- Amputation, Traumatic
- Keywords
- Amputation, Prosthesis, peripheral nerves, ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasonographyAll 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. | Diagnostic test | – |
Primary outcome
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.
2 secondary outcomes
Visual analog scale (VAS)
Time frame: through study completion, an average of one and a half months
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)
Time frame: through study completion, an average of one and a half months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sefa Gümrük Aslan, MD principal investigator
Gaziler PMR, Training and Research Hospital, Department of PMR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation, Traumatic, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2020.