Post Burn Cubital Tunnel SyndromeNCT07102992
Post Burn Cubital Tunnel Syndrome Electrophysioligical and Functional Responses to High Intensity Laser Therapy Versus Extracorperal Shock Wave Therapy.
A study testing High intensity laser therapy, Shock Wave therapy and Ulnar nerve gliding exercises. in people with Post Burn Cubital Tunnel Syndrome, run by Ahram Canadian University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Post Burn Cubital Tunnel Syndrome
- What is being tested?
- High intensity laser therapy, Shock Wave therapy and Ulnar nerve gliding exercises.
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Aug 2025to 5 Jun 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Out patient clinic , faculty of Physical Therapy, ahram Canadian university
Giza, Giza Governorate
About this study
Official title: Post Burn Cubital Tunnel Syndrome Electrophysioligical and Functional Responses to High Intensity Laser Therapy Versus Extracorperal Shock Wave Therapy, Arandomized Controlled Trial
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.
Read the 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.
- Conditions
- Post Burn Cubital Tunnel Syndrome
- Being tested
- High intensity laser therapy, Shock Wave therapy, Ulnar nerve gliding exercises.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity laser therapyDevice
Laser therapy was delivered using a high-intensity laser therapy (HILT) device (HIRO 3, 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.
Shock Wave therapyDevice
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.
Ulnar nerve gliding exercises.Other
Also called Ulnar nerve gliding exercises
Ulnar nerve gliding exercise was performed in a seated position with the shoulder abducted to 90° and externally rotated,, neck in a contralateral side bending, forearm pronated, and wrist and fingers extended, participants slowly flex the elbow while flexing the wrist and fingers, then returned to the starting position.
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.
| Study group | Role | What they receive |
|---|---|---|
| High intensity laser therapy | Experimental | Device: High intensity laser therapy 25 Patients Receives: Device: High intensity laser therapy; Other: Ulnar nerve gliding exercises. |
| Shock Wave therapy | Active comparator | Extracorporeal shock wave therapy, 25 patients Receives: Device: Shock Wave therapy; Other: Ulnar nerve gliding exercises. |
| Ulnar nerve gliding exercises. | Active comparator | Ulnar nerve gliding exercises, 25 patients Receives: Other: Ulnar nerve gliding exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 week and 12 week
Secondary outcomes (1)
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.
Measured: Baseline, 4 week and 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start5 Aug 2025
- Primary completion3 Apr 2026
- Study completion5 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Burn Cubital Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel group randomized controlled trial with 3 arms receiving different interventions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University
- Responsible party
- Principal investigator, Mahmoud H Mohamed, PhD, Ahram Canadian University
- Investigators
- Waleed Mansour, Ph.D, Study chair, Faculty of Physical Therapy, Benha university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102992
- Sponsor's protocol ID
- HILT-SHWT 2025
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided