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| Name | Class |
|---|---|
| Benha University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High intensity laser therapy | Experimental | Device: High intensity laser therapy 25 Patients |
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| Shock Wave therapy | Active Comparator | Extracorporeal shock wave therapy, 25 patients |
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| Ulnar nerve gliding exercises. | Active Comparator | Ulnar nerve gliding exercises, 25 patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 was given 5 times / week for 20 sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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. | Baseline, 4 week and 12 week |
| Measure | Description | Time Frame |
|---|---|---|
| The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire | The 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. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Waleed Mansour, Ph.D | Faculty of Physical Therapy, Benha university | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Out patient clinic , faculty of Physical Therapy, ahram Canadian university | Giza | Giza Governorate | Egypt |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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This is a parallel group randomized controlled trial with 3 arms receiving different interventions.
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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.
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| 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 was given 1 time / week for 4 sessions. |
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| 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 was given 5 times / week for 20 sessions. |
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| Baseline, 4 week and 12 week |
| D026741 |
| Physical Therapy Modalities |
| D012046 | Rehabilitation |