Multimodal Approach of Electrotherapy Versus Nerve Flossing Technique in Patient With Carpal Tunnel Syndrome (CTS)

February 22, 2023 updated by: heba Haridy, October 6 University

Carpal tunnel syndrome (CTS) is the most common and median nerve neuropathy at the wrist, caused by compression of the median nerve at the level of the carpal tunnel (CT) delimitated by the carpal bones and the transverse carpal ligament(TCL) which is the intermediate part of the flexor retinaculum (FR).

The CTS remains a challenge for health care providers due to its high prevalence and economic consequences, it is projected that in every 5 patients, 1 complains of symptoms of pain, numbness and a tingling sensation in the hands, CTS is estimated to occur in 3.8% of the general population with an incidence rate of 276:100000 per year and happens more frequently in women than in men so a prevalence rate of 9.2% in women and 6% in men

Study Overview

Detailed Description

The CTS is a common clinical problem caused by the entrapment of the median nerve at the wrist, It is an important mononeuropathy that causes of hand pain, neurologic symptoms, and functional limitation of the hand, It is the most common nerve compression disorder of the upper extremity ,it accounting for 90% of all neuropathies, It is estimated that CTS affects approximately is between 3.7% and 5.8% of the general population with a prevalence rate up to 9.2% in women and 6% in men , CTS is 10 times more frequent in women than men , the peak age range of CTS is between 40 to 60 years ,it is mostly seen in women ages between 30 to 50 years due to the housework they do, however, it occurs in all age groups

Study Type

Interventional

Enrollment (Anticipated)

76

Phase

  • 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

Ages Eligible for Study

30 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Fifty one female patients have unilateral with mild to moderate CTS in dominant hand diagnosed and reffered by physician.

Age will be ranged from 30-45years (Atya et al.,2020) Patients with mild to moderate CTS will particiepate into the current study according to the classification of AAEM

Exclusion Criteria:

Patients with diabetes mellities ( type I or type II), Patients with Hypertension Patients with hypothyroidism Patients with rheumatological disease Patients with renal disease

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group A
17 subjects will receive multimodal approach of electrotherapy (LLLT , US and IFC) with conventional physical therapy modalities in the form of ( splint and therapeutic exercises ) 3 sessions every week for 8 weeks.
subjects will receive multimodal approach of electrotherapy (LLLT , US and IFC) with conventional physical therapy modalities in the form of ( splint and therapeutic exercises ) 3 sessions every week for 8 weeks.
Experimental: group B
17 subjects will receive NFT with conventional physical therapy modalities in the form of (splint and therapeutic exercises ) 3 sessions every week for 8 weeks.
subjects will receive NFT with conventional physical therapy modalities in the form of (splint and therapeutic exercises ) 3 sessions every week for 8 weeks.
Experimental: group C
17 subjects will receive with conventional physical therapy modalities only in the form of (splint and therapeutic exercises ) 3 sessions every week for 8 weeks.
subjects will receive with conventional physical therapy modalities only in the form of (splint and therapeutic exercises ) 3 sessions every week for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight and height scale
Time Frame: 8 weeks
Weighting scale will administreted by using (SH-8024) , it will be used to measure weight in kg and height in cm , of all patients before starting the assessment for determining BMI
8 weeks
Visual analogue scale
Time Frame: 8 weeks
The VAS consists of a 10-cm line, with the left extremity indicating ''no pain'' and the right extremity indicating ''unbearable pain.'' Participants asked to use the scale to indicate their current level of pain Higher values suggest more intense pain ,It was found that VAS provide valid and reliable assessments for the affective magnitude, as well as the sensation intensity of pain.
8 weeks

Collaborators and Investigators

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

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)

September 1, 2023

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

December 5, 2021

First Submitted That Met QC Criteria

December 5, 2021

First Posted (Actual)

December 20, 2021

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

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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