Post Burn Cubital Tunnel Syndrome Response to High Intensity Laser Therapy Versus Shock Wave Therapy

NCT ID: NCT07102992

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-05

Study Completion Date

2026-05-01

Brief Summary

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Significant morbidity in burn patients occurs frequently because of Post burn nerve entrapment syndromes. Nerve entrapment arises due to direct compression because of edema; they may also present due to scar tissue formation.

Burns of the forearm and elbow are associated with swelling, redness and pain. In second to third-degree burns, the eschar forms a tight band constricting the circulation distally and forms edema that leads to compression neuropathy of ulnar nerve. Also the hyper metabolic response of the burned patients, has been suggested as a cause of the peripheral neuropathies, as the basal metabolic rate (B.M.R) of the burned patients increase more than 2 to 2.5 times normal.

Detailed Description

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Significant morbidity in burn patients occurs frequently because of Post burn nerve entrapment syndromes. Nerve entrapment arises due to direct compression because of edema; they may also present due to scar tissue formation.

Burns of the forearm and elbow are associated with swelling, redness and pain. In second to third-degree burns, the eschar forms a tight band constricting the circulation distally and forms edema that leads to compression neuropathy of ulnar nerve. Also the hyper metabolic response of the burned patients, has been suggested as a cause of the peripheral neuropathies, as the basal metabolic rate (B.M.R) of the burned patients increase more than 2 to 2.5 times normal.

Cubital tunnel syndrome is the second most common entrapment neuropathy of the upper extremity, after carpal tunnel syndrome

Conditions

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Post Burn Cubital Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a parallel group randomized controlled trial with 3 arms receiving different interventions.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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High intensity laser therapy

Device: High intensity laser therapy 25 Patients

Group Type EXPERIMENTAL

Ulnar nerve gliding exercises.

Intervention Type OTHER

While keeping patients head in a neutral position, will teach the patient to:

1. Begin with your arm out, palm side of the hand facing up.
2. Bend the elbow toward you, palm side facing you.
3. Rotate the palm of your hand outward and bend your wrist so that the fingers are pointing towards you.
4. Twist your wrist so that the palm of your hand is now facing upward.
5. While your wrist remains bent, stretch out your arm into a straight position, with your fingers bent towards the floor.

Hold each position for 5 seconds, repeat series 3-5 times. Frequency of treatment: Treatment will be given 5 times / week for 20 sessions.

High intensity laser therapy

Intervention Type DEVICE

High intensity Laser Therapy :A standard handpiece endowed with fixed spacers will used to provide the same distance to the skin and perpendicularly to the zone to be treated with a laser beam diameter of 5 mm. Three phases of treatment will be performed for every session. The total energy that will be delivered to the patient during one session will be 1275 J through three phases of treatment.

Frequency of treatment: Treatment will be given 5 times / week for 20 sessions.

Shock Wave therapy

Extracorporeal shock wave therapy, 25 patients

Group Type ACTIVE_COMPARATOR

Ulnar nerve gliding exercises.

Intervention Type OTHER

While keeping patients head in a neutral position, will teach the patient to:

1. Begin with your arm out, palm side of the hand facing up.
2. Bend the elbow toward you, palm side facing you.
3. Rotate the palm of your hand outward and bend your wrist so that the fingers are pointing towards you.
4. Twist your wrist so that the palm of your hand is now facing upward.
5. While your wrist remains bent, stretch out your arm into a straight position, with your fingers bent towards the floor.

Hold each position for 5 seconds, repeat series 3-5 times. Frequency of treatment: Treatment will be given 5 times / week for 20 sessions.

Shock Wave therapy

Intervention Type DEVICE

radial extracorporeal shock wave therapy (2,000 shots, 4 Bar, 5 Hz) (once a week) will be administered to the ulnar nerve at the proximal cubital tunnel region.

Frequency of treatment: Treatment will be given 1 time / week for 4 sessions

Ulnar nerve gliding exercises.

Ulnar nerve gliding exercises, 25 patients

Group Type ACTIVE_COMPARATOR

Ulnar nerve gliding exercises.

Intervention Type OTHER

While keeping patients head in a neutral position, will teach the patient to:

1. Begin with your arm out, palm side of the hand facing up.
2. Bend the elbow toward you, palm side facing you.
3. Rotate the palm of your hand outward and bend your wrist so that the fingers are pointing towards you.
4. Twist your wrist so that the palm of your hand is now facing upward.
5. While your wrist remains bent, stretch out your arm into a straight position, with your fingers bent towards the floor.

Hold each position for 5 seconds, repeat series 3-5 times. Frequency of treatment: Treatment will be given 5 times / week for 20 sessions.

Interventions

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Ulnar nerve gliding exercises.

While keeping patients head in a neutral position, will teach the patient to:

1. Begin with your arm out, palm side of the hand facing up.
2. Bend the elbow toward you, palm side facing you.
3. Rotate the palm of your hand outward and bend your wrist so that the fingers are pointing towards you.
4. Twist your wrist so that the palm of your hand is now facing upward.
5. While your wrist remains bent, stretch out your arm into a straight position, with your fingers bent towards the floor.

Hold each position for 5 seconds, repeat series 3-5 times. Frequency of treatment: Treatment will be given 5 times / week for 20 sessions.

Intervention Type OTHER

High intensity laser therapy

High intensity Laser Therapy :A standard handpiece endowed with fixed spacers will used to provide the same distance to the skin and perpendicularly to the zone to be treated with a laser beam diameter of 5 mm. Three phases of treatment will be performed for every session. The total energy that will be delivered to the patient during one session will be 1275 J through three phases of treatment.

Frequency of treatment: Treatment will be given 5 times / week for 20 sessions.

Intervention Type DEVICE

Shock Wave therapy

radial extracorporeal shock wave therapy (2,000 shots, 4 Bar, 5 Hz) (once a week) will be administered to the ulnar nerve at the proximal cubital tunnel region.

Frequency of treatment: Treatment will be given 1 time / week for 4 sessions

Intervention Type DEVICE

Other Intervention Names

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Ulnar nerve gliding exercises

Eligibility Criteria

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Inclusion Criteria

1. Age 20-50 years.
2. Both sexes.
3. Post healed elbow burn.
4. Diagnosed with cubital tunnel syndrome.
5. Willing and able to provide informed consent.

Exclusion Criteria

1. Patients with brachial plexopathy.
2. C8-T1 radiculopathy, polyneuropathy.
3. Previous elbow fractures or operation.
4. Systemic diseases such as diabetes mellitus, malignancy, and active infection.
5. Patients with any contraindications to high intensity laser therapy or shock wave therapy.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role collaborator

Ahram Canadian University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud H Mohamed, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Waleed Mansour, Ph.D

Role: STUDY_CHAIR

Faculty of Physical Therapy, Benha university

Locations

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Out patient clinic , faculty of Physical Therapy, Benha university

Banhā, Al Qalyubia, Egypt

Site Status RECRUITING

Out patient clinic , faculty of Physical Therapy, ahram Canadian university

Giza, Giza Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mahmoud Mohamed, Ph.D

Role: CONTACT

01111750888

Waleed Mansour, Ph.D

Role: CONTACT

01005311168

Other Identifiers

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HILT-SHWT 2025

Identifier Type: -

Identifier Source: org_study_id

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