Effect of Chitosan Phonophoresis On Cubital Tunnel Syndrome

October 6 University

Status: Completed

Conditions: Ulnar Nerve Entrapment Syndrome; Ulnar Nerve Entrapment at Elbow; Cubital Tunnel Syndrome; Ulnar Nerve Compression

Treatments: Device: Therapeutic Ultrasound; Device: Splinting; Device: Chitosan Phonophoresis; Other: Neural mobilization exercises of the ulnar nerve

Study type: Interventional

Funder types: Other

Identifiers

NCT05212311

CUTS001

Details and patient eligibility

About

• 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.

Enrollment: 54 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups

Group A (Control group)

Active Comparator group

Description:

Group A (n=27) will receive a conventional physical therapy program only for 5 weeks in the form of Splinting, Ultrasound and Exercises.

Treatment:

Device: Chitosan Phonophoresis

Other: Neural mobilization exercises of the ulnar nerve

Device: Splinting

Group B (Chitosan phonophoresis group)

Experimental group

Description:

Patients in group B (n=27) will receive phonophoresis with chitosan nanoparticles. Patients will also receive the conventional physical therapy program: in the form of Splinting, Ultrasound and Exercises. Session will be applied 3 times per week for a total of 5 weeks.

Treatment:

Device: Therapeutic Ultrasound

Other: Neural mobilization exercises of the ulnar nerve

Device: Splinting