- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05164237
Multimodal Approach of Electrotherapy Versus Nerve Flossing Technique in Patient With Carpal Tunnel Syndrome (CTS)
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
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt
- Recruiting
- Heba
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Contact:
- Emad mohamed
- Phone Number: +201146808839
- Email: emadeldin.mohamed.pt@o6u.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
|---|---|
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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.
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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.
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|
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.
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subjects will receive NFT with conventional physical therapy modalities in the form of (splint and therapeutic exercises ) 3 sessions every week for 8 weeks.
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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.
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subjects will receive with conventional physical therapy modalities only in the form of (splint and therapeutic exercises ) 3 sessions every week for 8 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight and height scale
Time Frame: 8 weeks
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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
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8 weeks
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Visual analogue scale
Time Frame: 8 weeks
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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.
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8 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 85632
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Carpal Tunnel Syndrome
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Stanford UniversityMayo Clinic; National Institute of Arthritis and Musculoskeletal and Skin Diseases... and other collaboratorsCompletedCarpal Tunnel Syndrome | Carpal Tunnel | Carpal Tunnel Syndrome Bilateral | Carpal Tunnel Syndrome Left | Carpal Tunnel Syndrome RightUnited States
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Issa, Abdulhamid Sayed, M.D.CompletedCarpal Tunnel Syndrome | CTS | Carpal Tunnel Release | Carpal Tunnel Surgery | Carpal Tunnel Transverse ApproachSyrian Arab Republic
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Ankara UniversityNot yet recruitingCarpal Tunnel Syndrome (CTS)Turkey (Türkiye)
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