Effect of Neurodynamic Mobilization on Median Nerve Conduction Velocity in Carpal Tunnel Syndrome

March 28, 2023 updated by: Raghda Ahmed Mohammed Ebrahim, Cairo University

The purpose of this study is to examine:

  1. The effect of neurodynamic mobilization on the sensory and motor median nerve conduction velocity in carpal tunnel syndrome.
  2. The effect of neurodynamic mobilization on the wrist pain in carpal tunnel syndrome.
  3. The effect of neurodynamic mobilization on the hand function in carpal tunnel syndrome.

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.

Detailed Description

The findings of this study will provide physiotherapists with information to know if neurodynamic mobilization techniques is effective on median nerve conduction velocity in carpal tunnel syndrome also this will improve our body of knowledge about the best modalities for treating carpal tunnel syndrome. The finding of this study may help carpal tunnel syndrome patients to avoid the exposing to complications as a result of compression of median nerve in carpal tunnel syndrome.

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 (Anticipated)

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.
40

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Dokki, Egypt
        • Outpatient clinic faculty of physica therapy cairo university

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

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Forty carpal tunnel syndrome patients.
  • All participants referred from a physician.
  • Their ages range from 20-50 years old.
  • Both genders will participate in the study.
  • Their BMI ranges between 18.5-24.9kg/m2.
  • All participants have carpal tunnel syndrome at least in one hand.
  • All participants suffering from mild to moderate carpal tunnel syndrome.

Exclusion Criteria:

  • Previous or current disease or trauma that might affect one or both upper limbs.
  • Metabolic diseases that might associated with entrapment neuropathy such as diabetes mellitus, thyroid diseases, and autoimmune diseases.
  • Pregnant women.
  • Participants with congenital hand deformities.
  • History of hand surgery.
  • Sever cases of carpal tunnel syndrome that suffering from weakness of hand grip and atrophy of thenar muscle.

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.
Active Comparator: Conventional treatment group
Twenty patients will receive conventional treatment in the form of superficial heat, ultrasound with freq of 1 MHz, pulsed mode 1:4 for 5 min and stretching exercise to lumbrical muscles of the hand.
Other: conventional Treatment
It consists of Superficial heat, Ultrasound therapy and stretching exercise to lumbrical muscles of the hand.
Experimental: Neurodynamic mobilization therapy group
Twenty patients will receive neurodynamic mobilization therapy (upper limb tension test 1) in addition to conventional treatment.
Other: conventional Treatment
It consists of Superficial heat, Ultrasound therapy and stretching exercise to lumbrical muscles of the hand.
Other: Neurodynamic mobilization
It is the mobilisation of the nervous system as an approach to physical treatment of pain. The treatment and or assessment relies on influencing pain physiology via the mechanical treatment of neural tissues and non-neural structures surrounding the nervous system.

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
Measure Description
Time Frame
Assessing the change in nerve conduction velocity of the median nerve.
Time Frame: at baseline and after 4 weeks of intervention
By using Electromyography apparatus measuring nerve conduction velocity of the median nerve. (motor and sensory in m/s)
at baseline and after 4 weeks of intervention
Assessing the change in wrist joint pain
Time Frame: at baseline and after 4 weeks of intervention
By using Pressure pain threshold (PPT) is defined as the minimal amount of pressure that produces pain. A simple handheld pressure algometer (PA) with a spring is commonly used, although more sophisticated electrical devices with a strain or pneumatic pressure gauge have been developed. They hold the peak force or pressure (kp (kilopond) = 10 N, Newton = 100 kPa (kilopascal)) until tared, and some may also be connected to a computer and thus have continuous output. PPT measured with a probe 1.6 mm in diameter or larger reflects the tenderness of deep tissues as anesthesia of skin only affects the results of smaller probes.
at baseline and after 4 weeks of intervention
Assessing the change in functional activity of the hand
Time Frame: at baseline and after 4 weeks of intervention
By using Modified DASH questionnaire will be used for functional activity of the hand. The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity/function level.
at baseline and after 4 weeks of 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.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Raghda Ahmed, Cairo University

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 (Anticipated)

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.
April 1, 2023

Primary Completion (Anticipated)

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.
June 15, 2023

Study Completion (Anticipated)

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.
August 15, 2023

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).
March 15, 2023

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.
March 28, 2023

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.
March 29, 2023

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.
March 29, 2023

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.
March 28, 2023

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.
March 1, 2023

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.
  • Raghda Ahmed_PhD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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