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

NCT05876442 | Unknown

• 1 other identifier: P.T.REC/012/004498
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Symptoms and Functions.

  2 months

• Median Nerve conduction Study

  2 months

• Muscle strength assessment

  2 Months

Study Arms (4)

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

EXPERIMENTAL

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.; Device: High Intensity Laser Therapy; Other: Traditional Physical Therapy Exercise Program

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

EXPERIMENTAL

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.; Other: Traditional Physical Therapy Exercise Program

Experimental: Group C:HILTplus Traditional Physical Therapy Exercise.

EXPERIMENTAL

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; Other: Traditional Physical Therapy Exercise Program

Traditional Physical Therapy Exercise.

ACTIVE COMPARATOR

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

Interventions

Extracorporeal Shock Wave Therapy. DEVICE

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

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

High Intensity Laser Therapy DEVICE

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

Experimental: Group C:HILTplus Traditional Physical Therapy Exercise.; Group A: ESWT plus HILT in addition to Traditional Physical Therapy Exercise .

Traditional Physical Therapy Exercise Program OTHER

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 B: ESWT plus Traditional Physical Therapy Exercise .; Experimental: Group C:HILTplus Traditional Physical Therapy Exercise.; Group A: ESWT plus HILT in addition to Traditional Physical Therapy Exercise .; Traditional Physical Therapy Exercise.

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University, Faculty of Physical Therapy

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Burns; Carpal Tunnel Syndrome

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries; Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Hadaya M Eladl, PhD

CONTACT

00201281968332; hd_mos@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: May 25, 2023
• Study Start: May 20, 2023
• Primary Completion: May 30, 2024
• Study Completion: June 1, 2024
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be shared after six months ofpublication.
• Access Criteria: Study Protocol Study results

Locations

EG (1)