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Low Intensity Ultrasound in Patients With Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
low intensity pulsed ultrasound
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 26 male and 26 female patients have unilateral with mild to moderate CTS in dominant hand diagnosed and referred by physician. Age will be ranged from 30-50 years All patients have body mass index between 18.5 and 24.9 kg/m2 Median nerve sensory distal latency > 3.5 millisecond but not more than 4.5 millisecond, motor distal latency longer than 4.2 millisecond but not exceed 6.5 millisecond. Positive clinical manifestation (pain, paresthesia in the distribution of the median nerve for 6 months, positive Tinel's and Phalen's sign) Exclusion Criteria: Patients with diabetes mellitus ( type I or type II), Patients with hypothyroidism Patients with rheumatoid disease Patients with renal disease Patients with polyneuropathy patients with cervical radiculopathy Patients with wrist arthritis , wrist fracture and acute trauma Patients with Carpal tunnel release surgery Patients with outlet syndrome thenar muscle atrophy -

Sites / Locations

  • Faculty of Physical Therapy Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

low intensity pulsed ultrasound group

control group

Arm Description

low intensity pulsed ultrasound application The following parameters will be used: intensity of 0.3 W/cm2 at a 1megahertz frequency for 20 minutes and pulsed (20%) ultrasound waves and conventional physical therapy program will be used for this group in a form of wrist hand Splint ,Medical Massage (effleurage),Passive stretching for wrist flexor, Carpal mobilization and Strengthening exercise

conventional physical therapy program will be used for this group in a form of wrist hand Splint ,Medical Massage (effleurage),Passive stretching for wrist flexor, Carpal mobilization and Strengthening exercise

Outcomes

Primary Outcome Measures

median nerve sensory distal latency
Measurements of sensory distal latency of median nerve (Antidromic technique ) Recording electrode or Ring electrode (R1, R2): at the index finger the negative electrode is between 2-3 cm to positive electrode (Distance between stimulating and recording sites 5 cm). Stimulating site (S): at the wrist (Middle of the wrist between the tendons to the flexor carpi radialis and palmaris longus) Ground (Earth) electrode (G): between stimulating and recording electrodes will be placed at the palmar surface of the wrist crease.
median nerve motor distal latency
Measurements of motor distal latency of median nerve (Using Orthodromic technique) Recording (-) active electrode (R1): abductor pollicis brevis (APB). Reference(+) electrode (R2): placed over the first metacarpal-phalangeal joint Stimulating electrode (S): 2 stimulating sites at wrist and antecubital fossa (Cathode toward recording electrode). Ground (Earth) electrode (G): around the wrist crease between stimulating and recording electrodes
pinch grip strength
grip strength will be measured using a calibrated baseline hydraulic dynamometer, while the subject will be seated with the arm adducted, elbow flexed at 90 degree, forearm in neutral position firstly, therapist will ask patient to hold the dynamometer between the tip of the thumb and tip of the index finger it called (tip to tip pinch), as hard as possible in the hand to be tested, the patients strongly encouraged to give a maximum effort. One practice trial, Repeat the test 3 times and calculate an average with one min rest in between

Secondary Outcome Measures

Full Information

First Posted
November 14, 2022
Last Updated
December 1, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05637684
Brief Title
Low Intensity Ultrasound in Patients With Carpal Tunnel Syndrome
Official Title
Influence of Low Intensity Pulsed Ultrasound on Enhancing Biostimulation of Median Nerve in Patients With Chronic Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
To investigate the influence of low intensity pulsed ultrasound on Pain level, pinch grip strength, sensory distal latency of the median nerve, motor distal latency of the median nerve and hand function in patients with chronic carpal tunnel syndrome
Detailed Description
Carpal tunnel syndrome (CTS) is an entrapment neuropathy caused by compression of the median nerve as it travels through the wrist's carpal tunnel. It is the most common nerve entrapment neuropathy, accounting for 90% of all neuropathies. Early symptoms of carpal tunnel syndrome include pain, numbness, and paresthesia. These symptoms typically present, with some variability, in the thumb, index finger, middle finger, and the radial half (thumb side) of the ring finger. Pain also can radiate up the affected arm. With further progression, hand weakness, decreased fine motor coordination, clumsiness, and thenar atrophy can occur. Low-intensity ultrasound (LIU) and low-intensity pulsed ultrasound (LIPUS) are known to have positive effects on dentin genesis, cell proliferation, protein synthesis, collagen synthesis, membrane permeability, and integrin expression and to increase cytosolic calcium levels.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low intensity pulsed ultrasound group
Arm Type
Experimental
Arm Description
low intensity pulsed ultrasound application The following parameters will be used: intensity of 0.3 W/cm2 at a 1megahertz frequency for 20 minutes and pulsed (20%) ultrasound waves and conventional physical therapy program will be used for this group in a form of wrist hand Splint ,Medical Massage (effleurage),Passive stretching for wrist flexor, Carpal mobilization and Strengthening exercise
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
conventional physical therapy program will be used for this group in a form of wrist hand Splint ,Medical Massage (effleurage),Passive stretching for wrist flexor, Carpal mobilization and Strengthening exercise
Intervention Type
Device
Intervention Name(s)
low intensity pulsed ultrasound
Intervention Description
mechanical sound waves
Primary Outcome Measure Information:
Title
median nerve sensory distal latency
Description
Measurements of sensory distal latency of median nerve (Antidromic technique ) Recording electrode or Ring electrode (R1, R2): at the index finger the negative electrode is between 2-3 cm to positive electrode (Distance between stimulating and recording sites 5 cm). Stimulating site (S): at the wrist (Middle of the wrist between the tendons to the flexor carpi radialis and palmaris longus) Ground (Earth) electrode (G): between stimulating and recording electrodes will be placed at the palmar surface of the wrist crease.
Time Frame
4 WEEKS
Title
median nerve motor distal latency
Description
Measurements of motor distal latency of median nerve (Using Orthodromic technique) Recording (-) active electrode (R1): abductor pollicis brevis (APB). Reference(+) electrode (R2): placed over the first metacarpal-phalangeal joint Stimulating electrode (S): 2 stimulating sites at wrist and antecubital fossa (Cathode toward recording electrode). Ground (Earth) electrode (G): around the wrist crease between stimulating and recording electrodes
Time Frame
4 WEEKS
Title
pinch grip strength
Description
grip strength will be measured using a calibrated baseline hydraulic dynamometer, while the subject will be seated with the arm adducted, elbow flexed at 90 degree, forearm in neutral position firstly, therapist will ask patient to hold the dynamometer between the tip of the thumb and tip of the index finger it called (tip to tip pinch), as hard as possible in the hand to be tested, the patients strongly encouraged to give a maximum effort. One practice trial, Repeat the test 3 times and calculate an average with one min rest in between
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 26 male and 26 female patients have unilateral with mild to moderate CTS in dominant hand diagnosed and referred by physician. Age will be ranged from 30-50 years All patients have body mass index between 18.5 and 24.9 kg/m2 Median nerve sensory distal latency > 3.5 millisecond but not more than 4.5 millisecond, motor distal latency longer than 4.2 millisecond but not exceed 6.5 millisecond. Positive clinical manifestation (pain, paresthesia in the distribution of the median nerve for 6 months, positive Tinel's and Phalen's sign) Exclusion Criteria: Patients with diabetes mellitus ( type I or type II), Patients with hypothyroidism Patients with rheumatoid disease Patients with renal disease Patients with polyneuropathy patients with cervical radiculopathy Patients with wrist arthritis , wrist fracture and acute trauma Patients with Carpal tunnel release surgery Patients with outlet syndrome thenar muscle atrophy -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
FAHD A HASSAN
Phone
00201140202205
Email
FAHDPT@GMAIL.COM
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FAHD A HASSAN
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy Cairo University
City
Giza
State/Province
Dokki
ZIP/Postal Code
11432
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FAHD A HASSAN
Phone
00201140202205
Email
FAHDPT@GMAIL.COM

12. IPD Sharing Statement

Plan to Share IPD
No

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Low Intensity Ultrasound in Patients With Carpal Tunnel Syndrome

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