CTSNCT03970408
Median Nerve Excursion During Neurodynamic Mobilization
An observational study of CTS, run by Aliaa Rehan Youssef at 2 sites in Egypt.
Trial summary
This study will compare changes in longitudinal median nerve excursion when neck flexion and ipsilateral rotation are added to the standard Median neurodynamic test1 (MNT1) position in patients with carpal tunnel syndrome (CTS) and normal controls. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- CTS
- What is being tested?
- MNT1
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 May 2019to 1 Dec 2020
- 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients will be selected from primary care clinics.
Who may be able to join
- Clinical diagnosis of mild to moderate CTS.
- Must be able to tolerate the entire standard MNT1 position.
Who cannot join
- Severe CTS.
- Symptoms referred to the neck.
- Limited neck flexion, rotation, and side bending ranges (>10%).
- History of upper quadrant trauma, dysfunction or surgery.
- History of peripheral neuropathy or cervical radiculopathy.
- History of systemic disease associated with neuropathies such as diabetes mellitus, connective tissue diseases, thyroid disease, or obesity.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Effect of Neck Movements on Median Nerve Longitudinal Excursion During Neurodynamic Mobilization in Patients With Carpal Tunnel Syndrome
This study will compare changes in longitudinal median nerve excursion when neck flexion and ipsilateral rotation are added to the standard Median neurodynamic test1 (MNT1) position in patients with carpal tunnel syndrome (CTS) and normal controls.
Read the detailed description
Median nerve excursion will be assessed by ultrasonography during three positions: standard MNT1, neck flexion with MNT1, and ipsilateral rotation combined with MNT1. Both arms will be tested.
Arm will be held in abduction to 90° - 110° and external rotation to 90°, forearm supination, elbow extension and wrist and fingers extension using a custom made splint.
The standard MNT1 includes neck contralateral side flexion. Then, the researcher will move the neck passively into rotation and flexion. Passive range limit will be determined prior to testing using a goniometer and passive end feel. Movement order will be randomized using an excel random function.
Every position will be tested three times. A single researcher will do all movements passively. Nerve excursion will be measured in real time by the same ultrasonographer who is blinded to patients grouping.
- Conditions
- CTS
- Being tested
- MNT1
- Keywords
- Median nerve,, Carpal tunnel syndrome, Neurodynamic mobilization
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MNT1Procedure or surgery
Also called Neurodynamic tension test
Participants will in supine. Arm will be position in standard MNT1. Shoulder, elbow, wrist and fingers will be maintained in the required position using a costumed splint throughout all testing.
All movements will be limited to the range where pain or other symptoms are not provoked. Passive neck flexion and rotation will be added to MNT1 and will be applied as tensioning movements at level 3. All movements will be repeated three times and an average will be calculated. Myrin goniometer will be used to assess neck flexion and rotation. The movements order will be randomized using excel random generation function. Movements will be done by a single trained therapist. The end position will be held up to 10 seconds until median nerve excursion is recorded by US. For US capturing, the transducer will be positioned perpendicularly and aligned longitudinally with the median nerve at the wrist. Assessor will be blinded to participants grouping.
| Study group | Role | What they receive |
|---|---|---|
| Carpal tunnel syndrome | Patients with CTS who fulfill the following eligibility criteria:
Inclusion criteria
* Females and male patients referred with a CTS diagnosis confirmed by nerve conduction studies and positive Tinel and Phalen tests.
* Age ranging from 30-50 years old.
* The selected patient will be able to tolerate the entire standard neurodynamic technique.
Exclusion criteria
* Symptoms referred to the neck.
* Sever CTS
* More than 10% limitation of neck flexion, rotation, and side bending ranges.
* History of disease, trauma, or surgery to neck, thorax, or upper limbs.
* Presence of peripheral neuropathy or cervical radiculopathy.
* History of systemic disease associated with neuropathies such as diabetes mellitus, connective tissue diseases, thyroid disease, or obesity. Receives: Procedure: MNT1 | |
| Healthy control | Asymptomatic healthy age-matched control with no symptoms or history of upper quadrant disease, dysfunction, trauma or surgery. Receives: Procedure: MNT1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in longitudinal median nerve excursion with neck flexion
Changes in median nerve excursion, as measured by ultrasonography, when the neck is moved toward flexion combined with the standard MNT1
Measured: One day
Changes in longitudinal median nerve excursion with ipsilateral neck rotation
Changes in median nerve excursion changes, as measured by ultrasonography, when the neck is moved in ipsilateral rotation combined with the standard MNT1
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start1 May 2019
- Primary completion1 Sep 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for CTSStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aliaa Rehan Youssef
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aliaa Rehan Youssef, Cairo University
- Investigators
- Aliaa Rehan Youssef, Phd, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970408
- Sponsor's protocol ID
- HMahmoud
- Status last verified
- Jul 2020
- First submitted
- 25 May 2019
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ballestero-Perez R, Plaza-Manzano G, Urraca-Gesto A, Romo-Romo F, Atin-Arratibel MLA, Pecos-Martin D, Gallego-Izquierdo T, Romero-Franco N. Effectiveness of Nerve Gliding Exercises on Carpal Tunnel Syndrome: A Systematic Review. J Manipulative Physiol Ther. 2017 Jan;40(1):50-59. doi: 10.1016/j.jmpt.2016.10.004. Epub 2016 Nov 11.
PubMed 27842937Balogun, J. a, & Abereoje, O. K. (1989). Inter- and lntratester Reliability of Measuring Neck Motions with Tape Measure and Myrin Gravity reference goniometer. Orthopaedic & Sports Physical Therapy, 10(7), 248-253.
Bay BK, Sharkey NA, Szabo RM. Displacement and strain of the median nerve at the wrist. J Hand Surg Am. 1997 Jul;22(4):621-7. doi: 10.1016/S0363-5023(97)80118-9.
PubMed 9260616Bialosky JE, Bishop MD, Price DD, Robinson ME, Vincent KR, George SZ. A randomized sham-controlled trial of a neurodynamic technique in the treatment of carpal tunnel syndrome. J Orthop Sports Phys Ther. 2009 Oct;39(10):709-23. doi: 10.2519/jospt.2009.3117.
PubMed 19801812Botte MJ, von Schroeder HP, Abrams RA, Gellman H. Recurrent carpal tunnel syndrome. Hand Clin. 1996 Nov;12(4):731-43.
PubMed 8953292Boudier-Reveret M, Gilbert KK, Allegue DR, Moussadyk M, Brismee JM, Sizer PS Jr, Feipel V, Dugailly PM, Sobczak S. Effect of neurodynamic mobilization on fluid dispersion in median nerve at the level of the carpal tunnel: A cadaveric study. Musculoskelet Sci Pract. 2017 Oct;31:45-51. doi: 10.1016/j.msksp.2017.07.004. Epub 2017 Jul 17.
PubMed 28734168Brochwicz P, von Piekartz H, Zalpour C. Sonography assessment of the median nerve during cervical lateral glide and lateral flexion. Is there a difference in neurodynamics of asymptomatic people? Man Ther. 2013 Jun;18(3):216-9. doi: 10.1016/j.math.2012.10.001. Epub 2013 Jan 11.
PubMed 23317635Bueno-Gracia E, Ruiz-de-Escudero-Zapico A, Malo-Urries M, Shacklock M, Estebanez-de-Miguel E, Fanlo-Mazas P, Caudevilla-Polo S, Jimenez-Del-Barrio S. Dimensional changes of the carpal tunnel and the median nerve during manual mobilization of the carpal bones. Musculoskelet Sci Pract. 2018 Aug;36:12-16. doi: 10.1016/j.msksp.2018.04.002. Epub 2018 Apr 4.
PubMed 29635191Butler, D. S., & Jones, M. A. (1991). Mobilization of the Nervous System. In D. S. Butler & M. A. Jones (Eds.), clinical resoning (1st ed., pp. 91-105). Australia: Elsevier Health Sciences.
Coppieters MW, Butler DS. Do 'sliders' slide and 'tensioners' tension? An analysis of neurodynamic techniques and considerations regarding their application. Man Ther. 2008 Jun;13(3):213-21. doi: 10.1016/j.math.2006.12.008. Epub 2007 Mar 30.
PubMed 17398140Coppieters MW, Hough AD, Dilley A. Different nerve-gliding exercises induce different magnitudes of median nerve longitudinal excursion: an in vivo study using dynamic ultrasound imaging. J Orthop Sports Phys Ther. 2009 Mar;39(3):164-71. doi: 10.2519/jospt.2009.2913.
PubMed 19252262De-la-Llave-Rincon AI, Ortega-Santiago R, Ambite-Quesada S, Gil-Crujera A, Puentedura EJ, Valenza MC, Fernandez-de-las-Penas C. Response of pain intensity to soft tissue mobilization and neurodynamic technique: a series of 18 patients with chronic carpal tunnel syndrome. J Manipulative Physiol Ther. 2012 Jul;35(6):420-7. doi: 10.1016/j.jmpt.2012.06.002. Epub 2012 Jul 31.
PubMed 22858234Dilley A, Lynn B, Greening J, DeLeon N. Quantitative in vivo studies of median nerve sliding in response to wrist, elbow, shoulder and neck movements. Clin Biomech (Bristol). 2003 Dec;18(10):899-907. doi: 10.1016/s0268-0033(03)00176-1.
PubMed 14580833Duncan, S. F. M., & Kakinoki Ryosuke. (2017). Carpal Tunnel Syndrome and Related Median Neuropathies. In M. E. Cooke & S. F. M. Duncan (Eds.), Challenges and Complications. (1st ed., pp. 7-11). USA: Springer.
Echigo A, Aoki M, Ishiai S, Yamaguchi M, Nakamura M, Sawada Y. The excursion of the median nerve during nerve gliding exercise: an observation with high-resolution ultrasonography. J Hand Ther. 2008 Jul-Sep;21(3):221-7; quiz 228. doi: 10.1197/j.jht.2007.11.001.
PubMed 18652966
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neck Movements on Median Nerve Longitudinal Excursion During Neurodynamic Mobilization in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT03970408
- Acronym / sponsor ID
- HMahmoud
- Conditions
- CTS
- Keywords
- Median nerve,, Carpal tunnel syndrome, Neurodynamic mobilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Aliaa Rehan YoussefUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 31 May 2019 (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.
This study will compare changes in longitudinal median nerve excursion when neck flexion and ipsilateral rotation are added to the standard Median neurodynamic test1 (MNT1) position in patients with carpal tunnel syndrome (CTS) and normal controls.
Detailed description
Median nerve excursion will be assessed by ultrasonography during three positions: standard MNT1, neck flexion with MNT1, and ipsilateral rotation combined with MNT1. Both arms will be tested.
Arm will be held in abduction to 90° - 110° and external rotation to 90°, forearm supination, elbow extension and wrist and fingers extension using a custom made splint.
The standard MNT1 includes neck contralateral side flexion. Then, the researcher will move the neck passively into rotation and flexion. Passive range limit will be determined prior to testing using a goniometer and passive end feel. Movement order will be randomized using an excel random function.
Every position will be tested three times. A single researcher will do all movements passively. Nerve excursion will be measured in real time by the same ultrasonographer who is blinded to patients grouping.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carpal tunnel syndrome | – | Procedure: MNT1Patients with CTS who fulfill the following eligibility criteria: Inclusion criteria * Females and male patients referred with a CTS diagnosis confirmed by nerve conduction studies and positive Tinel and Phalen tests. * Age ranging from 30-50 years old. * The selected patient will be able to tolerate the entire standard neurodynamic technique. Exclusion criteria * Symptoms referred to the neck. * Sever CTS * More than 10% limitation of neck flexion, rotation, and side bending ranges. * History of disease, trauma, or surgery to neck, thorax, or upper limbs. * Presence of peripheral neuropathy or cervical radiculopathy. * History of systemic disease associated with neuropathies such as diabetes mellitus, connective tissue diseases, thyroid disease, or obesity. |
| Healthy control | – | Procedure: MNT1Asymptomatic healthy age-matched control with no symptoms or history of upper quadrant disease, dysfunction, trauma or surgery. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients will be selected from primary care clinics.
Key inclusion criteria (2 listed)
- Clinical diagnosis of mild to moderate CTS.
- Must be able to tolerate the entire standard MNT1 position.
Key exclusion criteria (6 listed)
- Severe CTS.
- Symptoms referred to the neck.
- Limited neck flexion, rotation, and side bending ranges (>10%).
- History of upper quadrant trauma, dysfunction or surgery.
- History of peripheral neuropathy or cervical radiculopathy.
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 |
|---|---|---|
| MNT1Also: Neurodynamic tension testParticipants will in supine. Arm will be position in standard MNT1. Shoulder, elbow, wrist and fingers will be maintained in the required position using a costumed splint throughout all testing. All movements will be limited to the range where pain or other symptoms are not provoked. Passive neck flexion and rotation will be added to MNT1 and will be applied as tensioning movements at level 3. All movements will be repeated three times and an average will be calculated. Myrin goniometer will be used to assess neck flexion and rotation. The movements order will be randomized using excel random generation function. Movements will be done by a single trained therapist. The end position will be held up to 10 seconds until median nerve excursion is recorded by US. For US capturing, the transducer will be positioned perpendicularly and aligned longitudinally with the median nerve at the wrist. Assessor will be blinded to participants grouping. | Procedure or surgery | Carpal tunnel syndrome, Healthy control |
Primary outcome
Changes in longitudinal median nerve excursion with neck flexion
Time frame: One day
Changes in median nerve excursion, as measured by ultrasonography, when the neck is moved toward flexion combined with the standard MNT1
Changes in longitudinal median nerve excursion with ipsilateral neck rotation
Time frame: One day
Changes in median nerve excursion changes, as measured by ultrasonography, when the neck is moved in ipsilateral rotation combined with the standard MNT1
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 28 Jul 2021.
- Background: PubMed 27842937Ballestero-Perez R, Plaza-Manzano G, Urraca-Gesto A, Romo-Romo F, Atin-Arratibel MLA, Pecos-Martin D, Gallego-Izquierdo T, Romero-Franco N. Effectiveness of Nerve Gliding Exercises on Carpal Tunnel Syndrome: A Systematic Review. J Manipulative Physiol Ther. 2017 Jan;40(1):50-59. doi: 10.1016/j.jmpt.2016.10.004. Epub 2016 Nov 11.
- BackgroundBalogun, J. a, & Abereoje, O. K. (1989). Inter- and lntratester Reliability of Measuring Neck Motions with Tape Measure and Myrin Gravity reference goniometer. Orthopaedic & Sports Physical Therapy, 10(7), 248-253.
- Background: PubMed 9260616Bay BK, Sharkey NA, Szabo RM. Displacement and strain of the median nerve at the wrist. J Hand Surg Am. 1997 Jul;22(4):621-7. doi: 10.1016/S0363-5023(97)80118-9.
- Background: PubMed 19801812Bialosky JE, Bishop MD, Price DD, Robinson ME, Vincent KR, George SZ. A randomized sham-controlled trial of a neurodynamic technique in the treatment of carpal tunnel syndrome. J Orthop Sports Phys Ther. 2009 Oct;39(10):709-23. doi: 10.2519/jospt.2009.3117.
- Background: PubMed 8953292Botte MJ, von Schroeder HP, Abrams RA, Gellman H. Recurrent carpal tunnel syndrome. Hand Clin. 1996 Nov;12(4):731-43.
- Background: PubMed 28734168Boudier-Reveret M, Gilbert KK, Allegue DR, Moussadyk M, Brismee JM, Sizer PS Jr, Feipel V, Dugailly PM, Sobczak S. Effect of neurodynamic mobilization on fluid dispersion in median nerve at the level of the carpal tunnel: A cadaveric study. Musculoskelet Sci Pract. 2017 Oct;31:45-51. doi: 10.1016/j.msksp.2017.07.004. Epub 2017 Jul 17.
- Background: PubMed 23317635Brochwicz P, von Piekartz H, Zalpour C. Sonography assessment of the median nerve during cervical lateral glide and lateral flexion. Is there a difference in neurodynamics of asymptomatic people? Man Ther. 2013 Jun;18(3):216-9. doi: 10.1016/j.math.2012.10.001. Epub 2013 Jan 11.
- Background: PubMed 29635191Bueno-Gracia E, Ruiz-de-Escudero-Zapico A, Malo-Urries M, Shacklock M, Estebanez-de-Miguel E, Fanlo-Mazas P, Caudevilla-Polo S, Jimenez-Del-Barrio S. Dimensional changes of the carpal tunnel and the median nerve during manual mobilization of the carpal bones. Musculoskelet Sci Pract. 2018 Aug;36:12-16. doi: 10.1016/j.msksp.2018.04.002. Epub 2018 Apr 4.
- BackgroundButler, D. S., & Jones, M. A. (1991). Mobilization of the Nervous System. In D. S. Butler & M. A. Jones (Eds.), clinical resoning (1st ed., pp. 91-105). Australia: Elsevier Health Sciences.
- Background: PubMed 17398140Coppieters MW, Butler DS. Do 'sliders' slide and 'tensioners' tension? An analysis of neurodynamic techniques and considerations regarding their application. Man Ther. 2008 Jun;13(3):213-21. doi: 10.1016/j.math.2006.12.008. Epub 2007 Mar 30.
- Background: PubMed 19252262Coppieters MW, Hough AD, Dilley A. Different nerve-gliding exercises induce different magnitudes of median nerve longitudinal excursion: an in vivo study using dynamic ultrasound imaging. J Orthop Sports Phys Ther. 2009 Mar;39(3):164-71. doi: 10.2519/jospt.2009.2913.
- Background: PubMed 22858234De-la-Llave-Rincon AI, Ortega-Santiago R, Ambite-Quesada S, Gil-Crujera A, Puentedura EJ, Valenza MC, Fernandez-de-las-Penas C. Response of pain intensity to soft tissue mobilization and neurodynamic technique: a series of 18 patients with chronic carpal tunnel syndrome. J Manipulative Physiol Ther. 2012 Jul;35(6):420-7. doi: 10.1016/j.jmpt.2012.06.002. Epub 2012 Jul 31.
- Individual participant dataSharing planned: Undecided
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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.
Aliaa Rehan Youssef, Phd principal investigator
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CTS, run by Aliaa Rehan Youssef at 2 sites in Egypt.
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 6 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 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Changes in longitudinal median nerve excursion with neck flexion (time frame: One day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03970408, which also lists 47 linked publications.
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 28 Jul 2021.