Low Intensity Ultrasound in Patients With Carpal Tunnel Syndrome

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

low intensity pulsed ultrasound

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

NCT ID

NCT05637684

First Posted

November 14, 2022

Last Updated

December 1, 2022

Sponsor

Cairo University

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

Carpal Tunnel Syndrome

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial