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

Burn Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05876442
• Other study ID #: P.T.REC/012/004498
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: October 2023
• Source: Cairo University
• Contact: Hadaya M Eladl, PhD
• Phone: 00201281968332
• Email: hd_mos[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 1, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn Injury
• Burns
• Carpal Tunnel Syndrome
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Cairo University, Faculty of Physical Therapy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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