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

Overview

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.

Full Title of Study: “Efficacy of Extracorporeal Shock Wave Therapy Plus High-Intensity LaserTherapy on Pain, Range of Motion, Quality of Life, Muscle Strength, and Nerve Conduction Velocity in Carpal Tunnel Syndrome Post Burn Injury”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Single (Investigator)
• Study Primary Completion Date: May 30, 2024

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, range of motion, muscle strength, and quality of life in inpatients with carpal tunnel syndrome post-burn injuries

Interventions

• Device: Extracorporeal Shock Wave Therapy.
  • Patients will receive EPSW therapy at the area of the wrist for 5 minutes 3 times a week for 3 months.
• Device: High Intensity Laser Therapy
  • High intensity laser therapy at the area of the carpal bones for 5 minutes 2 times a week.
• 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

Arms, Groups and Cohorts

• 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 3 times a week for 3 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.
• 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 3 times a week for 3 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
• 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. 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
• 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.

Clinical Trial Outcome Measures

Primary Measures

• Pain Intensity.
  • Time Frame: 3 months
  • 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 Measures

• Range of motion
  • Time Frame: 3 months
  • Range of motion of wrist flexion and extension, ulnar and radial deviation will bemeasured by goniometer at baseline and at the end of the 3 months
• Median Nerve conduction Study
  • Time Frame: 3 months
  • median nerve conduction study will be measured at the base line and at the end of the treatment period of three months.
• Muscle strength assessment
  • Time Frame: 3 Months
  • will be measured using the hand held daynamo-meter at the beginning and at the end of 3 months after treatment

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Cairo University
• Provider of Information About this Clinical Study
  • Principal Investigator: Hadaya Mosaad, Principal Investigator – Cairo University
• Overall Contact(s)
  • Hadaya M Eladl, PhD, 00201281968332, hd_mos@yahoo.com