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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07102992
Enrollment
75
Registered
2025-08-05
Start date
2025-08-05
Completion date
2026-06-05
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Burn Cubital Tunnel Syndrome

Brief summary

Post-burn cubital tunnel syndrome is a disabling complication that may occur after upper-limb burns involving the elbow due to edema, scar formation, and tissue compression around the ulnar nerve. This randomized controlled trial compared the additive effects of high-intensity laser therapy (HILT) and extracorporeal shock wave therapy (ESWT), when combined with ulnar nerve gliding exercises, on electrophysiological parameters and upper-limb function in adults with clinically and electrophysiologically confirmed unilateral post-burn cubital tunnel syndrome following healed second- or third-degree burns.

Detailed description

Peripheral nerve entrapment is a recognized complication of burn injuries. Following second- or third-degree burns involving the elbow, edema, scar tissue formation, and tissue contracture may contribute to compression of the ulnar nerve within the cubital tunnel. Patients with post-burn cubital tunnel syndrome commonly experience pain, paresthesia, sensory disturbances, and impaired upper-limb function. Cubital tunnel syndrome is the second most common entrapment neuropathy of the upper extremity after carpal tunnel syndrome. Given the limited evidence regarding conservative management of post-burn cubital tunnel syndrome, this assessor-blinded, parallel-group randomized controlled trial evaluated the effects of high-intensity laser therapy (HILT) and extracorporeal shock wave therapy (ESWT), each combined with ulnar nerve gliding exercises, compared with ulnar nerve gliding exercises alone. The study assessed changes in motor nerve conduction velocity, compound muscle action potential amplitude, and upper-limb function in adults aged 20-50 years with healed unilateral second- or third-degree upper-limb burns involving the elbow and clinically and electrophysiologically confirmed unilateral post-burn cubital tunnel syndrome.

Interventions

DEVICEHigh 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 was given 5 times / week for 20 sessions.

DEVICEShock 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 was given 1 time / week for 4 sessions.

OTHERUlnar 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 was given 5 times / week for 20 sessions.

Sponsors

Ahram Canadian University
Lead SponsorOTHER
Benha University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Due to the distinct tactile and visible nature of the electrophysical modalities, true patient and therapist blinding was not feasible after the interventions commenced. However, to mitigate potential expectation bias, participants were framed to understand that the study was evaluating the comparative clinical outcomes of different advanced rehabilitation approaches and were not informed which intervention was hypothesized to be superior.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Men and women aged 20-50 years. * Healed unilateral second- or third-degree upper-limb burns involving the elbow with a total body surface area (TBSA) \<20%. * Unilateral post-burn cubital tunnel syndrome confirmed clinically (including Tinel's sign) and electrophysiologically by focal slowing of ulnar nerve conduction across the elbow. * Ability and willingness to provide informed consent and comply with the study protocol.

Exclusion criteria

* Severe axonal loss indicating direct ulnar nerve injury. * Generalized neuropathy or abnormal nerve conduction in the contralateral upper limb. * Concurrent median or radial neuropathy or brachial plexus injury. * Previous elbow fracture, ulnar nerve surgery, or extensive reconstructive procedures around the cubital tunnel (simple skin grafting permitted). * Diabetes mellitus, active malignancy, pregnancy, active infection, coagulopathy, or cardiac pacemaker implantation. * Other neurological disorders affecting upper-limb function. * Participation in another rehabilitation or interventional study during the study period. * Inability to adhere to the treatment protocol or scheduled assessments.

Design outcomes

Primary

MeasureTime frameDescription
Nerve Conduction Studies of ulnar nerveBaseline, 4 week and 12 weekUlnar 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 and follow up after 12 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.

Secondary

MeasureTime frameDescription
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaireBaseline, 4 week and 12 weekThe DASH questionnaire consists of 30 questions regarding limitations to complete physical activities due to upper extremity pain/impairment. Participants were asked to respond to each question based on their experiences over the preceding week according to a 5-point Likert scale ranging from 1 (no difficulty) to 5 (unable to do). Responses were scored out of 5 and averaged to produce a score out of 100 with higher scores representing greater disability.

Countries

Egypt

Contacts

STUDY_CHAIRWaleed Mansour, Ph.D

Faculty of Physical Therapy, Benha university

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026