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

May 1, 2024 updated by: Elena Bueno Gracia, Universidad de Zaragoza

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Distal motor latency (APB) (ms)
Time Frame: Before and immediately after the intervention
Before and immediately after the intervention
Motor amplitude (APB) (mV)
Time Frame: Before and immediately after the intervention
Before and immediately after the intervention
Median motor velocity (m/s)
Time Frame: Before and immediately after the intervention
Before and immediately after the intervention
Median sensory conduction (digit II) (13 cm) (m/sec)
Time Frame: Before and immediately after the intervention
Before and immediately after the intervention
Sensory amplitude (µV)
Time Frame: Before and immediately after the intervention
Before and immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Zaragoza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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