Effect of Chitosan Phonophoresis On Cubital Tunnel Syndrome

Not Applicable

Completed

• Conditions: Cubital Tunnel Syndrome; Ulnar Nerve Compression; Ulnar Nerve Entrapment at Elbow; Ulnar Nerve Entrapment Syndrome
• Interventions: Device: Therapeutic Ultrasound; Device: Chitosan Phonophoresis; Device: Splinting; Other: Neural mobilization exercises of the ulnar nerve

• Registration Number: NCT05212311
• Lead Sponsor: October 6 University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-15
• Study First Submitted QC: 2022-01-15
• Study First Posted: 2022-01-28
• Study Start: 2022-03-08
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B (Chitosan phonophoresis group)	Therapeutic Ultrasound	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.
Group B (Chitosan phonophoresis group)	Neural mobilization exercises of the ulnar nerve	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.
Group A (Control group)	Splinting	Group A (n=27) will receive a conventional physical therapy program only for 5 weeks in the form of Splinting, Ultrasound and Exercises.
Group A (Control group)	Chitosan Phonophoresis	Group A (n=27) will receive a conventional physical therapy program only for 5 weeks in the form of Splinting, Ultrasound and Exercises.
Group A (Control group)	Neural mobilization exercises of the ulnar nerve	Group A (n=27) will receive a conventional physical therapy program only for 5 weeks in the form of Splinting, Ultrasound and Exercises.
Group B (Chitosan phonophoresis group)	Splinting	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.

Primary Outcome Measures

Name	Time	Method
Changes in ulnar nerve conduction velocity from baseline and 5 weeks posttreatment	Changes in ulnar nerve conduction velocity from baseline and 5 weeks posttreatment	Measurement of how quickly an electrical impulse moves along the nerve.

Secondary Outcome Measures

Name	Time	Method
Changes in function using QUICK DASH scale at 5 weeks posttreatment	Changes in function using QUICK DASH scale from baseline and 5 weeks posttreatment	the quickdash is a validated outcome measure for hand function, scored 0-100 with higher scores indicating worse disability which is bad.
Changes in pain intensity at 5 weeks posttreatment	Changes in pain intensity from baseline and 5 weeks posttreatment	pain (min-max:0-10) Higher scores correlate to higher intensity of pain

Trial Locations

Locations (1)

October 6 University Hospital; 🇪🇬 Al Ḩayy Ath Thāmin, Giza, Egypt