In Patients With Carpal Tunnel Syndrome, Median Nerve Conduction is Evaluated After Nerve Mobilizations

Immediate Effect of Median Nerve Mobilization on Neural Conduction in Patients With Carpal Tunnel Syndrome: Randomized Clinical Trial

This project is linked to the line of research on carpal tunnel syndrome, of the PhysiUZerapy research group, belonging to the University of Zaragoza. Within this line, the biomechanical and physiological effect of the proposed technique has been investigated, both in healthy subjects, in cadavers and in patients with carpal tunnel syndrome (CTS), resulting in the reading of 2 doctoral theses, the publication of 9 articles in high-impact journals. and the patent for a splint for the treatment of pathology. This project aims to provide information that is still lacking on the immediate effect of these techniques in patients with CTS. For this, there will be three groups of patients from the Lozano Blesa University Clinical Hospital distributed randomly. In two of the groups, sliding and neural tension techniques will be carried out (case group). The remaining group (control group) will be taken as a reference by performing a placebo treatment. Before and after carrying out these techniques, electrophysiological data will be collected to be able to compare them. This comparison is based on highlighting the differences between the data before the techniques and after, as well as between the case group and the control group.

Study Overview

• Status: Not yet recruiting
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Other: Manual mobilizations of the median nerve; Other: Wrist movements

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain, 50009
    • Hospital Clinico Universitario Lozano Blesa
    • Contact: Diego Rodríguez; Phone Number: 976765700; Email: comunicacion3@salud.aragon.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Being over 18 years
• Present carpal tunnel syndrome diagnosed by electroneurogram
• Have understanding and communication skills
• Give consent to participate in the study

Exclusion Criteria:

• Have received previous surgery on the hand or wrist
• Present a severe limitation of movement in any of the joints of the affected upper limb
• Not signing the informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neural mobilization group; Manual mobilizations of the median nerve.	Other: Manual mobilizations of the median nerve; Slippage of the median nerve in the wrist: the subject's starting position (P0) will be recumbent supine with the cervical spine in a neutral position, the shoulder girdle in neutral position, 30º of glenohumeral abduction in neutral rotation, 90º of elbow flexion, prone-supination of the neutral forearm, wrist and fingers in neutral position. From this position the movements will be 1) Glenohumeral abduction up to 90º; 2) Glenohumeral external rotation to the frontal plane; 3) Supination of the forearm; 4) Extension of the wrist and fingers; 5) Elbow extension. This position is will combine with an ipsilateral cervical inclination (distal sliding). The proximal slide is carried out bringing the fingers of the hand towards the flexion while performing a contralateral cervical tilt. Median nerve tension: the starting position and movements are the same described above but this time it will be done with contralateral cervical tilt.
Placebo Comparator: Placebo group; wrist movements no producing sliding of the median nerve	Other: Wrist movements; Movements of the wrist joint will be performed as a placebo treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Distal motor latency (APB) (ms)	Before and immediately after the intervention
Motor amplitude (APB) (mV)	Before and immediately after the intervention
Median motor velocity (m/s)	Before and immediately after the intervention
Median sensory conduction (digit II) (13 cm) (m/sec)	Before and immediately after the intervention
Sensory amplitude (µV)	Before and immediately after the intervention

Collaborators and Investigators

• Sponsor: Universidad de Zaragoza

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2024
• Primary Completion (Estimated): September 15, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: PI23/437

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No