Median Nerve DiseaseNCT04218175
Effects of Neuromobilization on Median Nerve Elasticity
A study testing neuromobilization exercises in people with Median Nerve Disease, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: The aim of this study was to investigate the effect of median nerve neuromobilization on median nerve elasticity using shear wave elastography. Methods: The study included 36 healthy volunteers (72 upper extremities) aged 18-30 years. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Median Nerve Disease
- What is being tested?
- neuromobilization exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2019to 25 Dec 2019
- Phase
- Interventional
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-30 years of age
- Healthy individuals without any known systemic disease
Who cannot join
- Those who have undergone an upper extremity bone-tendon-muscle operation in the last six months
- People with a systemic disease such as rheumatoid arthritis, diabetes mellitus
- Patients with any neuromuscular disease
Trial locations and contacts
1 site in 1 country.
About this study
Purpose: The aim of this study was to investigate the effect of median nerve neuromobilization on median nerve elasticity using shear wave elastography.
Methods: The study included 36 healthy volunteers (72 upper extremities) aged 18-30 years. Inclusion criteria; no known systemic neuromuscular and metabolic diseases, no nerve impingement syndrome, and no upper extremity bone-tendon-muscle surgery in the last six months. Sociodemographic data of the participants were recorded. Wrist flexion and extension bilaterally with universal goniometer and finger grip strength bilaterally were measured with pinchmeter. Median Nerve Stress Test was performed. Median nerve elasticity was measured by Shear Wave Ultrasound Elastography. The extremity of the dominant side as a study group and the non-dominant side as a control group were measured bilaterally. Median nerve neuromobilization (stretching (n = 18) and shifting (n = 18)) was applied to the upper extremities of the dominant side. The application was carried out as 3 sets in one session. Evaluations were repeated after application.
- Conditions
- Median Nerve Disease
- Being tested
- neuromobilization exercises
- Keywords
- neuromobilization, elasticity, shear wave elastography
- Medical subject headings
- Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromobilization exercisesOther
Median nerve neuromobilization (stretching and shifting) was performed. For median nerve stretching; The subjects were brought to shoulder depression and 90 degrees of abduction while the dominant side forearms were supination. In this position, median nerve stretching was performed by extending the participant's head to the opposite side while flexing the wrist and finger. After waiting for 30 seconds in this position, the wrist and head were moved to the neutral position and the participants relaxed. For median nerve shift; The subjects were brought to shoulder depression and 90 degrees of abduction while the dominant side forearms were supination. In this position, the participant flexed his wrist and fingers while lateral flexion of his head to the opposite side, and flexed his wrist and fingers while lateral flexion of the head to the same side.
| Study group | Role | What they receive |
|---|---|---|
| neuromobilization stretching group | Experimental | In the neuromobilization stretching group; The subjects were brought to shoulder depression and 90 degrees of abduction while the dominant side forearms were supination. In this position, median nerve stretching was performed by extending the participant's head to the opposite side while flexing the wrist and finger. After waiting for 30 seconds in this position, the wrist and head were moved to the neutral position and the participants relaxed. Receives: Other: neuromobilization exercises |
| neuromobilization shifting group | Experimental | In the neuromobilization shifting group, the subjects were brought to shoulder depression and 90 degrees of abduction while the dominant forearms were supination. In this position, the participant flexed his wrist and fingers while lateral flexion of his head to the opposite side, and flexed his wrist and fingers while lateral flexion of the head to the same side. Thus, the participants performed median nerve shift. Receives: Other: neuromobilization exercises |
| Control Group | No intervention | The dominant sides of the individuals are experimental sides and the other nondominant sides of the participants are control sides. And no intervention was made. All measurements were done bilaterally before and after. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Nerve Tension Test
The test was performed in a position with shoulder depression and 90 degrees abduction and external rotation, elbow 90 degrees flexion, forearm full supination, and wrist and fingers fully extended. Maintaining this position, the elbow was passively extended and the tension of the median nerve was tested. The test was stopped at the point where the patient felt pain and tension, and the angle at the elbow was measured by a universal goniometer.
Measured: 4 weeks
Median nerve elasticity with Shear Wave Ultrasound Elastography
The nerve elasticity was measured by measuring the velocity of shear waves in the median nerve by means of high frequency ultrasound waves.
Measured: 4 weeks
Bilaterally finger grip strength with pinchmeter
finger grip strength was measured bilaterally by pinch meter.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start10 Nov 2019
- Primary completion15 Dec 2019
- Study completion25 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Median Nerve DiseaseStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The researcher who performed shear wave elastography did not know which group the case was evaluated during the measurement.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Çırak, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218175
- Sponsor's protocol ID
- 005
- Status last verified
- Jul 2020
- First submitted
- 2 Jan 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neuromobilization on Median Nerve Elasticity
- ClinicalTrials.gov ID
- NCT04218175
- Acronym / sponsor ID
- 005
- Conditions
- Median Nerve Disease
- Keywords
- neuromobilization, elasticity, shear wave elastography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 10 Nov 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 25 Dec 2019 (actual)
- First posted
- 6 Jan 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.
Purpose: The aim of this study was to investigate the effect of median nerve neuromobilization on median nerve elasticity using shear wave elastography.
Methods: The study included 36 healthy volunteers (72 upper extremities) aged 18-30 years. Inclusion criteria; no known systemic neuromuscular and metabolic diseases, no nerve impingement syndrome, and no upper extremity bone-tendon-muscle surgery in the last six months. Sociodemographic data of the participants were recorded. Wrist flexion and extension bilaterally with universal goniometer and finger grip strength bilaterally were measured with pinchmeter. Median Nerve Stress Test was performed. Median nerve elasticity was measured by Shear Wave Ultrasound Elastography. The extremity of the dominant side as a study group and the non-dominant side as a control group were measured bilaterally. Median nerve neuromobilization (stretching (n = 18) and shifting (n = 18)) was applied to the upper extremities of the dominant side. The application was carried out as 3 sets in one session. Evaluations were repeated after application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The researcher who performed shear wave elastography did not know which group the case was evaluated during the measurement.
| Arm | Type | Receives |
|---|---|---|
| neuromobilization stretching group | Experimental | Other: neuromobilization exercisesIn the neuromobilization stretching group; The subjects were brought to shoulder depression and 90 degrees of abduction while the dominant side forearms were supination. In this position, median nerve stretching was performed by extending the participant's head to the opposite side while flexing the wrist and finger. After waiting for 30 seconds in this position, the wrist and head were moved to the neutral position and the participants relaxed. |
| neuromobilization shifting group | Experimental | Other: neuromobilization exercisesIn the neuromobilization shifting group, the subjects were brought to shoulder depression and 90 degrees of abduction while the dominant forearms were supination. In this position, the participant flexed his wrist and fingers while lateral flexion of his head to the opposite side, and flexed his wrist and fingers while lateral flexion of the head to the same side. Thus, the participants performed median nerve shift. |
| Control Group | No intervention | –The dominant sides of the individuals are experimental sides and the other nondominant sides of the participants are control sides. And no intervention was made. All measurements were done bilaterally before and after. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-30 years of age
- Healthy individuals without any known systemic disease
Key exclusion criteria (3 listed)
- Those who have undergone an upper extremity bone-tendon-muscle operation in the last six months
- People with a systemic disease such as rheumatoid arthritis, diabetes mellitus
- Patients with any neuromuscular disease
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 |
|---|---|---|
| neuromobilization exercisesMedian nerve neuromobilization (stretching and shifting) was performed. For median nerve stretching; The subjects were brought to shoulder depression and 90 degrees of abduction while the dominant side forearms were supination. In this position, median nerve stretching was performed by extending the participant's head to the opposite side while flexing the wrist and finger. After waiting for 30 seconds in this position, the wrist and head were moved to the neutral position and the participants relaxed. For median nerve shift; The subjects were brought to shoulder depression and 90 degrees of abduction while the dominant side forearms were supination. In this position, the participant flexed his wrist and fingers while lateral flexion of his head to the opposite side, and flexed his wrist and fingers while lateral flexion of the head to the same side. | Other | neuromobilization shifting group, neuromobilization stretching group |
Primary outcome
Median Nerve Tension Test
Time frame: 4 weeks
The test was performed in a position with shoulder depression and 90 degrees abduction and external rotation, elbow 90 degrees flexion, forearm full supination, and wrist and fingers fully extended. Maintaining this position, the elbow was passively extended and the tension of the median nerve was tested. The test was stopped at the point where the patient felt pain and tension, and the angle at the elbow was measured by a universal goniometer.
Median nerve elasticity with Shear Wave Ultrasound Elastography
Time frame: 4 weeks
The nerve elasticity was measured by measuring the velocity of shear waves in the median nerve by means of high frequency ultrasound waves.
Bilaterally finger grip strength with pinchmeter
Time frame: 4 weeks
finger grip strength was measured bilaterally by pinch meter.
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 30 Jul 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuromobilization exercises in people with Median Nerve Disease, run by Istinye University 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 2 inclusion and 3 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 30 Jul 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?
Median Nerve Tension Test (time frame: 4 weeks). The study lists 3 primary outcomes in all. 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 30 Jul 2020.