NCT07102992

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Ahram Canadian University · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Post Burn Cubital Tunnel Syndrome

Interventions

Type	Name	Description
DEVICE	High intensity laser therapy	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.
DEVICE	Shock Wave therapy	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.
OTHER	Ulnar nerve gliding exercises.	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.

Timeline

• Start date: 2025-08-05
• Primary completion: 2026-04-03
• Completion: 2026-04-03
• First posted: 2025-08-05
• Last updated: 2026-04-08

Locations

1 site across 1 country: Egypt