NCT03970408

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2020

Enrollment Period

1.3 years

First QC Date

May 25, 2019

Last Update Submit

July 27, 2021

Conditions

Keywords

Median nerve,Carpal tunnel syndromeNeurodynamic mobilization

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

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.

Procedure: MNT1

Healthy control

Asymptomatic healthy age-matched control with no symptoms or history of upper quadrant disease, dysfunction, trauma or surgery.

Procedure: MNT1

Interventions

MNT1PROCEDURE

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.

Also known as: Neurodynamic tension test
Carpal tunnel syndromeHealthy control

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients will be selected from primary care clinics.

You may qualify if:

  • Clinical diagnosis of mild to moderate CTS.
  • Must be able to tolerate the entire standard MNT1 position.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ain Shamas University

Cairo, Egypt

Location

Cairo University Hospital

Cairo, Egypt

Location

Related Publications (47)

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    BACKGROUND
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MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Officials

  • Aliaa Rehan Youssef, Phd

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor of Orthopedic Physical Therapy

Study Record Dates

First Submitted

May 25, 2019

First Posted

May 31, 2019

Study Start

May 1, 2019

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

July 28, 2021

Record last verified: 2020-07

Locations