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

Primary Purpose

Carpal Tunnel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
nerve flossing technique
multimodal electrotherapy
exercises
Sponsored by
October 6 University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Carpal Tunnel Syndrome focused on measuring Carpal Tunnel Syndrome

Eligibility Criteria

30 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HebaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

group A

group B

group C

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Weight and height scale
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
Visual analogue scale
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.

Secondary Outcome Measures

Full Information

First Posted
December 5, 2021
Last Updated
February 22, 2023
Sponsor
October 6 University
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1. Study Identification

Unique Protocol Identification Number
NCT05164237
Brief Title
Multimodal Approach of Electrotherapy Versus Nerve Flossing Technique in Patient With Carpal Tunnel Syndrome
Acronym
CTS
Official Title
Multimodal Approach of Electrotherapy Versus Nerve Flossing Technique in Patient With Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Carpal Tunnel Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Experimental
Arm Description
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.
Arm Title
group B
Arm Type
Experimental
Arm Description
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.
Arm Title
group C
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
nerve flossing technique
Intervention Description
subjects will receive NFT with conventional physical therapy modalities in the form of (splint and therapeutic exercises ) 3 sessions every week for 8 weeks.
Intervention Type
Other
Intervention Name(s)
multimodal electrotherapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
exercises
Intervention Description
subjects will receive with conventional physical therapy modalities only in the form of (splint and therapeutic exercises ) 3 sessions every week for 8 weeks.
Primary Outcome Measure Information:
Title
Weight and height scale
Description
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
Time Frame
8 weeks
Title
Visual analogue scale
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Heba
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emad mohamed
Phone
+201146808839
Email
emadeldin.mohamed.pt@o6u.edu.eg

12. IPD Sharing Statement

Learn more about this trial

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

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