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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03970408
Other study ID # HMahmoud
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2019
Est. completion date December 1, 2020

Study information

Verified date July 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date December 1, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 50 Years
Eligibility Inclusion Criteria: - Clinical diagnosis of mild to moderate CTS. - Must be able to tolerate the entire standard MNT1 position. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
MNT1
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.

Locations

Country Name City State
Egypt Ain Shamas University Cairo
Egypt Cairo University Hospital Cairo

Sponsors (1)

Lead Sponsor Collaborator
Aliaa Rehan Youssef

Country where clinical trial is conducted

Egypt, 

References & Publications (47)

Ballestero-Pérez R, Plaza-Manzano G, Urraca-Gesto A, Romo-Romo F, Atín-Arratibel MLÁ, Pecos-Martín 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. Review. — View Citation

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Heebner ML, Roddey TS. The effects of neural mobilization in addition to standard care in persons with carpal tunnel syndrome from a community hospital. J Hand Ther. 2008 Jul-Sep;21(3):229-40; quiz 241. doi: 10.1197/j.jht.2007.12.001. — View Citation

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Paquette P, Lamontagne M, Higgins J, Gagnon DH. Repeatability and Minimal Detectable Change in Longitudinal Median Nerve Excursion Measures During Upper Limb Neurodynamic Techniques in a Mixed Population: A Pilot Study Using Musculoskeletal Ultrasound Imaging. Ultrasound Med Biol. 2015 Jul;41(7):2082-6. doi: 10.1016/j.ultrasmedbio.2015.03.015. Epub 2015 Apr 11. — View Citation

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* Note: There are 47 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 One day
Primary 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 One day
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