Efficacy of EPSW Plus HILT on Carpal Tunnel Syndrome Post Burn Injury

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Extracorporeal Shock Wave Therapy.

High Intensity Laser Therapy

Traditional Physical Therapy Exercise Program

About this trial

This is an interventional treatment trial for Burn Injury focused on measuring Extracorporeal shock wave therapy, High Intensity Laser Therapy, Carpal Tunnel Syndrome

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients diagnosed with carpal tunnel syndrome after thermal burn injuries. Patients will be diagnosed with median nerve conduction study and Phalen sign and tinel test. Patients age: 20 to 60 years Exclusion Criteria: Patients with severe (absent sensory or motor waves) and mild (sensory nerve latency >3.5 ms at third digit) CTS according to EMG-NCV study. Conditions that could impact upon or impacted by outcome measures or laser intervention (e.g. hypothyroidism, cancer, active infection, pulmonary disease, acquired immunodeficiency syndrome, associated myopathy, myelopathy, history of neck and/or shoulder surgery, drugabuse, corticosteroids consumption, and pregnancy) Patients received continuous physical therapy or exercise during the previous two weeks or taking analgesic or anti-inflammatory drugs during the week prior to the baseline assessment

Sites / Locations

Cairo University, Faculty of Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Group A: ESWT plus HILT in addition to Traditional Physical Therapy Exercise .

Experimental: Group B: ESWT plus Traditional Physical Therapy Exercise .

Experimental: Group C:HILTplus Traditional Physical Therapy Exercise.

Traditional Physical Therapy Exercise.

Arm Description

patients will receive Extraporeal Shock wave therapy at the area of the wrist for 5 minutes 1 time a week for 2 months, then High-intensity laser therapy at the site of the carpal bones for 5 minutes 2 times a week. Then a program of traditional physical therapy exercises for post-burn carpal tunnel syndrome for 30 minutes of stretching exercise for the wrist and carpal region with the fingers flexed and extended. Followed by strengthening exercises for the wrist flexors, extensors, radial and ulnar deviation muscles. Mobilizing exercise, tendon gliding exercise, and instructed to wear a wrist splint at night.

Patients will receive Extraporeal Shock wave therapy at the area of the wrist for 5 minutes 1 time a week for 2 months, Then a traditional physical therapy exercise program for the post-burn carpal tunnel syndrome for 30 minutes of stretching exercise for the wrist and carpal region with the fingers flexed and extended. They were followed by strengthening exercises for the wrist flexors, extensors, and radial and ulnar deviation muscles. Mobilizing exercise, tendon gliding exercise, and instructed to wear a wrist splint at night

patients will receive High-intensity laser therapy at the area of the carpal bones for 5 minutes 2 times a week for 2 monthes. Then a program of traditional physical therapy exercises for post-burn carpal tunnel syndrome for 30 minutes of stretching exercise for the wrist and carpal region with the fingers flexed and extended. Followed by strengthening exercises for the wrist flexors, extensors, and radial and ulnar deviation muscles. Mobilizing exercise, tendon gliding exercises, and instructed to wear a wrist splint at night

patients will receive a program of traditional physical therapy exercise for post-burn carpal tunnel syndrome for 30 minutes of stretching exercise for the wrist and carpal region with the fingers flexed and extended. They were followed by strengthening exercises for the wrist flexors, extensors, and radial and ulnar deviation muscles. Mobilizing exercise, tendon gliding exercise, and instructed to wear a wrist splint at night.

Outcomes

Primary Outcome Measures

Pain Intensity.

Intensity of pain will be measured by visual analogue scale at baseline and at the end of the 3months. Visual analogue scale is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best).Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity

Secondary Outcome Measures

Symptoms and Functions.

Boston Carpal Tunnel Questionnaire (BCTQ) The BCTQ evaluates the severity of symptoms and the functional status of patients with carpal tunnel syndrome. The symptom severity scale (SSS) consists of 11 questions covering symptom severity including night and day numbness, pins and needles, pain, and muscle weakness and scores from 1 point (mildest) to 5 points (most severe). The functional status scale (FSS) consists of 8 points concerning the patient's problems in performing specific activities such as writing, holding a book, buttoning up the shirt, holding the phone, opening jam jar, doing hard house chores, taking a bath, carrying a shopping bag, and dressing ranging from 1 point (no difficulty with the activity) to 5 points (cannot perform the activity at all). The higher the score, the greater the severity of the symptoms, and the disability of the patient would be

Median Nerve conduction Study

median nerve conduction study will be measured at the base line and at the end of the treatment period of two months.

Muscle strength assessment

will be measured using the hand held daynamo-meter at the beginning and at the end of 2 months after treatment

Full Information

NCT ID

NCT05876442

First Posted

May 12, 2023

Last Updated

October 23, 2023

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05876442

Brief Title

Efficacy of EPSW Plus HILT on Carpal Tunnel Syndrome Post Burn Injury

Official Title

Efficacy of Extracorporeal Shock Wave Therapy Plus High-Intensity LaserTherapy on Carpal Tunnel Syndrome Post Burn Injury.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 20, 2023 (Actual)

Primary Completion Date

May 30, 2024 (Anticipated)

Study Completion Date

June 1, 2024 (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

5. Study Description

Brief Summary

To study the effect of adding ESWT as a noninvasive short-term treatment plus high-level laser therapy for moderate carpal-tunnel syndrome post-burn injuries.

Detailed Description

To study the effect of adding ESWT as a noninvasive short-term treatment plus high-level laser therapy for mild to moderate carpal tunnel syndrome post-burn injuries. The effects of combining EPSW with High-intensity Laser Therapy for improving pain, Symptoms and function of motion, muscle strength, and quality of life in inpatients with carpal tunnel syndrome post-burn injuries

6. Conditions and Keywords

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

Burn Injury

Keywords

Extracorporeal shock wave therapy, High Intensity Laser Therapy, Carpal Tunnel Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A: ESWT plus HILT in addition to Traditional Physical Therapy Exercise .

Arm Type

Experimental

Arm Description

patients will receive Extraporeal Shock wave therapy at the area of the wrist for 5 minutes 1 time a week for 2 months, then High-intensity laser therapy at the site of the carpal bones for 5 minutes 2 times a week. Then a program of traditional physical therapy exercises for post-burn carpal tunnel syndrome for 30 minutes of stretching exercise for the wrist and carpal region with the fingers flexed and extended. Followed by strengthening exercises for the wrist flexors, extensors, radial and ulnar deviation muscles. Mobilizing exercise, tendon gliding exercise, and instructed to wear a wrist splint at night.

Arm Title

Experimental: Group B: ESWT plus Traditional Physical Therapy Exercise .

Arm Type

Experimental

Arm Description

Patients will receive Extraporeal Shock wave therapy at the area of the wrist for 5 minutes 1 time a week for 2 months, Then a traditional physical therapy exercise program for the post-burn carpal tunnel syndrome for 30 minutes of stretching exercise for the wrist and carpal region with the fingers flexed and extended. They were followed by strengthening exercises for the wrist flexors, extensors, and radial and ulnar deviation muscles. Mobilizing exercise, tendon gliding exercise, and instructed to wear a wrist splint at night

Arm Title

Experimental: Group C:HILTplus Traditional Physical Therapy Exercise.

Arm Type

Experimental

Arm Description

patients will receive High-intensity laser therapy at the area of the carpal bones for 5 minutes 2 times a week for 2 monthes. Then a program of traditional physical therapy exercises for post-burn carpal tunnel syndrome for 30 minutes of stretching exercise for the wrist and carpal region with the fingers flexed and extended. Followed by strengthening exercises for the wrist flexors, extensors, and radial and ulnar deviation muscles. Mobilizing exercise, tendon gliding exercises, and instructed to wear a wrist splint at night

Arm Title

Traditional Physical Therapy Exercise.

Arm Type

Active Comparator

Arm Description

patients will receive a program of traditional physical therapy exercise for post-burn carpal tunnel syndrome for 30 minutes of stretching exercise for the wrist and carpal region with the fingers flexed and extended. They were followed by strengthening exercises for the wrist flexors, extensors, and radial and ulnar deviation muscles. Mobilizing exercise, tendon gliding exercise, and instructed to wear a wrist splint at night.

Intervention Type

Device

Intervention Name(s)

Extracorporeal Shock Wave Therapy.

Intervention Description

Patients will receive EPSW therapy at the area of the wrist for 5 minutes 1 time a week for 2 months.

Intervention Type

Device

Intervention Name(s)

High Intensity Laser Therapy

Intervention Description

High-intensity laser therapy at the area of the carpal bones for 5 minutes 2 times a week for two months..

Intervention Type

Other

Intervention Name(s)

Traditional Physical Therapy Exercise Program

Intervention Description

30 minutes of stretching exercise for the wrist and carpal region with the fingers flexed and extended. Followed by strengthening exercises for the wrist flexors, extensors, and radial and ulnar deviation muscles. Mobilizing exercise, tendon gliding exercise, and instructed to wear a wrist splint at night for two months.

Primary Outcome Measure Information:

Title

Pain Intensity.

Description

Intensity of pain will be measured by visual analogue scale at baseline and at the end of the 3months. Visual analogue scale is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best).Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity

Time Frame

2 months

Secondary Outcome Measure Information:

Title

Symptoms and Functions.

Description

Boston Carpal Tunnel Questionnaire (BCTQ) The BCTQ evaluates the severity of symptoms and the functional status of patients with carpal tunnel syndrome. The symptom severity scale (SSS) consists of 11 questions covering symptom severity including night and day numbness, pins and needles, pain, and muscle weakness and scores from 1 point (mildest) to 5 points (most severe). The functional status scale (FSS) consists of 8 points concerning the patient's problems in performing specific activities such as writing, holding a book, buttoning up the shirt, holding the phone, opening jam jar, doing hard house chores, taking a bath, carrying a shopping bag, and dressing ranging from 1 point (no difficulty with the activity) to 5 points (cannot perform the activity at all). The higher the score, the greater the severity of the symptoms, and the disability of the patient would be

Time Frame

2 months

Title

Median Nerve conduction Study

Description

median nerve conduction study will be measured at the base line and at the end of the treatment period of two months.

Time Frame

2 months

Title

Muscle strength assessment

Description

will be measured using the hand held daynamo-meter at the beginning and at the end of 2 months after treatment

Time Frame

2 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Patients diagnosed with carpal tunnel syndrome after thermal burn injuries. Patients will be diagnosed with median nerve conduction study and Phalen sign and tinel test. Patients age: 20 to 60 years Exclusion Criteria: Patients with severe (absent sensory or motor waves) and mild (sensory nerve latency >3.5 ms at third digit) CTS according to EMG-NCV study. Conditions that could impact upon or impacted by outcome measures or laser intervention (e.g. hypothyroidism, cancer, active infection, pulmonary disease, acquired immunodeficiency syndrome, associated myopathy, myelopathy, history of neck and/or shoulder surgery, drugabuse, corticosteroids consumption, and pregnancy) Patients received continuous physical therapy or exercise during the previous two weeks or taking analgesic or anti-inflammatory drugs during the week prior to the baseline assessment

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hadaya M Eladl, PhD

Phone

00201281968332

Email

hd_mos@yahoo.com

Facility Information:

Facility Name

Cairo University, Faculty of Physical Therapy

City

Cairo

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hadaya M Eladl, PhD

Phone

00201281968332

Email

hd_mos@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Study results.

IPD Sharing Time Frame

Data will be shared after six months ofpublication.

IPD Sharing Access Criteria

Study Protocol Study results

Burn Injury

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

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