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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05164237
Other study ID # 85632
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date October 1, 2023

Study information

Verified date February 2023
Source October 6 University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 76
Est. completion date October 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers No
Gender All
Age group 30 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
nerve flossing technique
subjects will receive NFT with conventional physical therapy modalities in the form of (splint and therapeutic exercises ) 3 sessions every week for 8 weeks.
multimodal electrotherapy
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.
exercises
subjects will receive with conventional physical therapy modalities only in the form of (splint and therapeutic exercises ) 3 sessions every week for 8 weeks.

Locations

Country Name City State
Egypt Heba Cairo

Sponsors (1)

Lead Sponsor Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 8 weeks
Primary 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. 8 weeks
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