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

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05876442
Collaborator
(none)
120
4
12.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Extracorporeal Shock Wave Therapy.
  • Device: High Intensity Laser Therapy
  • Other: Traditional Physical Therapy Exercise Program
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
May 20, 2023
Anticipated Primary Completion Date :
May 30, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

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

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

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.

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

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

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

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

Outcome Measures

Primary Outcome Measures

  1. Pain Intensity. [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 Outcome Measures

  1. Range of motion [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

  2. Median Nerve conduction Study [3 months]

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

  3. Muscle strength assessment [3 Months]

    will be measured using the hand held daynamo-meter at the beginning and at the end of 3 months after treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hadaya Mosaad, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT05876442
Other Study ID Numbers:
  • P.T.REC/012/004498
First Posted:
May 25, 2023
Last Update Posted:
May 30, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hadaya Mosaad, Principal Investigator, Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 30, 2023