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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Burn Injury
• Intervention / Treatment: Device: Extracorporeal Shock Wave Therapy.; Device: High Intensity Laser Therapy; Other: Traditional Physical Therapy Exercise Program

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

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hadaya M Eladl, PhD; Phone Number: 00201281968332; Email: hd_mos@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo university, faculty of physical therapy
    • Contact: Hadaya M Eladl, PhD; Phone Number: 00201281968332; Email: hd_mos@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional Physical Therapy Exercise.; 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.	Other: Traditional Physical Therapy Exercise Program; 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.
Experimental: Group A: ESWT plus HILT in addition to Traditional Physical Therapy Exercise .; 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.	Device: Extracorporeal Shock Wave Therapy.; Patients will receive EPSW therapy at the area of the wrist for 5 minutes 1 time a week for 2 months.; Device: High Intensity Laser Therapy; High-intensity laser therapy at the area of the carpal bones for 5 minutes 2 times a week for two months..; Other: Traditional Physical Therapy Exercise Program; 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.
Experimental: Experimental: Group B: ESWT plus Traditional Physical Therapy Exercise .; 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	Device: Extracorporeal Shock Wave Therapy.; Patients will receive EPSW therapy at the area of the wrist for 5 minutes 1 time a week for 2 months.; Other: Traditional Physical Therapy Exercise Program; 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.
Experimental: Experimental: Group C:HILTplus Traditional Physical Therapy Exercise.; 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	Device: High Intensity Laser Therapy; High-intensity laser therapy at the area of the carpal bones for 5 minutes 2 times a week for two months..; Other: Traditional Physical Therapy Exercise Program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 months
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.	2 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	2 Months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2023
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: May 12, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Carpal Tunnel Syndrome; High Intensity Laser Therapy; Extracorporeal shock wave therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Burns; Carpal Tunnel Syndrome; Wounds and Injuries
• Other Study ID Numbers: P.T.REC/012/004498

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study results.
• IPD Sharing Time Frame: Data will be shared after six months ofpublication.
• IPD Sharing Access Criteria: Study Protocol Study results
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No