Clinical trial NCT05212311: Effect of Chitosan Phonophoresis On Cubital Tunnel Syndrome
Official title: Effect of Chitosan Phonophoresis On Cubital Tunnel Syndrome: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cubital Tunnel Syndrome
Ulnar Nerve Entrapment at Elbow
Ulnar Nerve Compression
Ulnar Nerve Entrapment Syndrome
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: - This study will be conducted to answer the following question: Is there a statistically significant effect of chitosan phonophoresis on ulnar nerve conduction velocity, pain level \& function in patients with mild to moderate cubital tunnel syndrome?

- Fifty-four subjects suffering from mild to moderate cubital tunnel syndrome according to modified McGowan grading system (Palmer \& Hughes, 2010) from both sexes diagnosed clinically by electromyography will be recruited for this study. The Age of the participants will range from 20 - 40 years old. Participants with Body mass index between 18.5 and 24.9kg/m2.

EMS physio Ltd ultrasound device will be used in combination with chitosan nanoparticles gel.

Electrodiagnostic test will be performed for ulnar nerve conduction velocity using Neuropack S1 MEB-9004 NIHON KODEN, JAPAN. Visual analogue scale (VAS) will be used to determine pain level. Quick DASH will be used to determine hand function.Patients will have 3 sessions per week for 5 weeks.


Eligibility criteria: Inclusion Criteria:

1. Fifty-four patients suffering from mild to moderate Cubital tunnel syndrome from both sexes according to modified McGowan grading system (Palmer \& Hughes, 2010) \& have motor conduction velocity across the elbow less than 50 m/s or the difference between the motor conduction velocity across the elbow and that below the elbow exceeds 10 m/s (Padua et al., 2001).
2. Age ranging from 20-35.
3. All participants will have Body mass index between 18.5 and 24.9 kg/m2.

Exclusion Criteria:

* 1- Diabetic patients. 2- Cardiovascular patients 3- Patients with cervical spondylosis 4- Patients with cervical disc prolapsed 5- Patients with Thoracic outlet syndrome 6- Patients with carpal tunnel syndrome. 7- Pregnant women 8- Patients with fibromyalgia 9- Patients with epicondylitis 10- Patient with previous elbow injuries 11- Patient with Breast Cancer. 12- Patient with Guyon Canal syndrome 13- Smokers

Primary outcomes:
measure: Changes in ulnar nerve conduction velocity from baseline and 5 weeks posttreatment
timeFrame: Changes in ulnar nerve conduction velocity from baseline and 5 weeks posttreatment
Secondary outcomes:
measure: Changes in pain intensity at 5 weeks posttreatment
timeFrame: Changes in pain intensity from baseline and 5 weeks posttreatment
measure: Changes in function using QUICK DASH scale at 5 weeks posttreatment
timeFrame: Changes in function using QUICK DASH scale from baseline and 5 weeks posttreatment
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: October 6 University Hospital
state: Giza
Study officials:
References: