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

NCT07102992 | Completed

• 1 other identifier: HILT-SHWT 2025
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Burn Cubital Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• Nerve Conduction Studies of ulnar nerve

  Ulnar nerve conduction studies were performed according to AAEM guidelines and reported in line with the TIDieR checklist. Diagnosis of cubital tunnel syndrome (CBTS) was confirmed using motor nerve conduction velocity (NCV) and compound muscle action potential (CMAP) of the ulnar nerve across the elbow. Assessments were conducted using a Neuropack S1 MEB-9004 (Nihon Kohden, Japan) by a certified electrophysiologist. CMAPs were recorded from the abductor digiti minimi with standardized patient positioning, and the ulnar nerve was stimulated at the wrist, below and above the elbow. Studies were performed at baseline and after 4 weeks in a temperature-controlled lab (25°C). NCV was calculated from distance and latency differences, while CMAP amplitude and latency were recorded to evaluate nerve function and treatment outcomes.

  Baseline and 4 weeks

Secondary Outcomes (1)

• The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire

  Baseline and 4 weeks

Study Arms (3)

High intensity laser therapy

EXPERIMENTAL

Device: High intensity laser therapy 25 Patients

Device: High intensity laser therapy; Other: Ulnar nerve gliding exercises.

Shock Wave therapy

ACTIVE COMPARATOR

Extracorporeal shock wave therapy, 25 patients

Device: Shock Wave therapy; Other: Ulnar nerve gliding exercises.

Ulnar nerve gliding exercises.

ACTIVE COMPARATOR

Ulnar nerve gliding exercises, 25 patients

Other: Ulnar nerve gliding exercises.

Interventions

Ulnar nerve gliding exercises. OTHER

Ulnar nerve gliding exercise was performed in a seated position with the shoulder abducted to approximately 90°, the forearm supinated, and the wrist and fingers initially maintained in extension. From this position, participants slowly extended the elbow while simultaneously flexing the wrist and fingers, followed by returning to the starting position by flexing the elbow while extending the wrist and fingers, thereby producing a sliding movement of the nerve rather than sustained tension. Participants were instructed to perform the movement within a pain-free range and to avoid reproduction of significant paresthesia. Each session consisted of three sets of 10-15 repetitions, performed at a slow and controlled pace, with 30-60 seconds of rest between sets. Progression involved gradually increasing elbow extension range as tolerated while maintaining symptom-free movement. Frequency of treatment: Treatment will be given 5 times / week for 20 sessions.

Also known as: Ulnar nerve gliding exercises

High intensity laser therapy; Shock Wave therapy; Ulnar nerve gliding exercises.

Shock Wave therapy DEVICE

Radial extracorporeal shock wave therapy was applied using a Swiss Dolor Clast device EMS Electro Medical Systems, Nyon, Switzerland. Patients were seated in a comfortable position with their target elbow at 40-50 degrees flexion on the table, delivering 2,000 shocks at 4 Bar and 5 Hz to the proximal cubital tunnel region, each session lasted 7 minutes, with the applicator positioned perpendicular to the skin using a coupling gel to ensure optimal energy transmission. Frequency of treatment: Treatment were given 1 time / week for 4 sessions.

Shock Wave therapy

High intensity laser therapy DEVICE

Laser therapy was delivered using a high-intensity laser therapy (HILT) device (M6, ASA srl, Arcugnano, Italy). The system is a Class IV Nd:YAG laser (1064 nm) capable of delivering high peak power in pulsed mode, enabling deeper tissue penetration and higher energy transfer. A 5 mm diameter laser beam, a handpiece with adjustable spacers was used to maintain a consistent distance from the skin and perpendicular to the treatment area. Each session included three therapy periods. The patient received 1275 J of energy in a single session, spread across three rounds. During the first stage, the medial epicondyle and forearm flexor muscles are manually scanned at a rate of 100 cm² per 30 seconds. The scanning procedure was conducted in each of the longitudinal and transverse orientations. This stage required providing a full energy dose of 625 J. The laser's intensity was adjusted to three subphases: 510 mJ Frequency of treatment: Treatment were given 5 times / week for 20 sessions.

High intensity laser therapy

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Patients with brachial plexopathy.
• C8-T1 radiculopathy, polyneuropathy.
• Previous elbow fractures or operation.
• Systemic diseases such as diabetes mellitus, malignancy, and active infection.
• Patients with any contraindications to high intensity laser therapy or shock wave therapy.

Sponsors & Collaborators

• Benha University: collaborator
• Ahram Canadian University: lead

Study Sites (1)

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

Giza, Giza Governorate, Egypt

Location

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

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

Study Officials

• Waleed Mansour, Ph.D

  Faculty of Physical Therapy, Benha university

  STUDY CHAIR

Study Design

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

Model Details: This is a parallel group randomized controlled trial with 3 arms receiving different interventions.

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: August 5, 2025
• Primary Completion: April 3, 2026
• Study Completion: April 3, 2026
• Last Updated: April 8, 2026

Record last verified: 2025-08

Locations

EG (1)