Effect of Chitosan Phonophoresis On Cubital Tunnel Syndrome

Cubital Tunnel Syndrome Clinical Trial

Official title:

Effect of Chitosan Phonophoresis On Cubital Tunnel Syndrome: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05212311
• Other study ID #: CUTS001
• Status: Completed
• Phase: N/A
• Start date: March 8, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: June 2023
• Source: October 6 University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Charcot-Marie-Tooth Disease
• Cubital Tunnel Syndrome
• Hereditary Sensory and Motor Neuropathy
• Nerve Compression Syndromes
• Syndrome
• Ulnar Nerve Compression
• Ulnar Nerve Entrapment at Elbow
• Ulnar Nerve Entrapment Syndrome

Intervention

Device:
• Chitosan Phonophoresis
Therapeutic pulsed ultrasound using EMS physio Ltd ultrasound device in presence of chitosan gel will be applied over the elbow. The following parameters will be used: US treatment was applied for 5 min per session at a frequency of 3 MHz and an intensity of 0.5 W/cm2 in pulsed mode with a transducer area of 5 cm2.
• Therapeutic Ultrasound
US treatment will be applied for 5 min per session at a frequency of 3 MHz and an intensity of 0.5 W/cm2 in pulsed mode with a transducer area of 5 cm2 using aquasonic gel.
• Splinting
Splinting the elbow in comfortable flexion (40-70), forearm and wrist in neutral (slight forearm pronation and wrist flexion if symptoms are severe), can allow the nerve and surrounding supporting structures the rest and relief from compression and traction. The elbow portion of the splint should be well padded or ''bubbled out'' to provide pressure relief for the area of the cubital tunnel. It may be necessary to splint the ulnar digits of the hand to prevent contracture, maintain passive and active range of motion, and improve hand function. If the motor branch of the nerve is sufficiently involved to cause muscle denervation, a hand-based intrinsic plus splint or the use of finger-based splints to prevent clawing of the ring and small fingers will provide balanced positioning of the affected structures.

Other:
• Neural mobilization exercises of the ulnar nerve
Nerve mobilization exercises Inflammation or adhesions anywhere along the ulnar nerve path can cause the nerve to have limited mobility and essentially get stuck in one place. These exercises help stretch the ulnar nerve and encourage movement through the cubital tunnel

Locations

Country	Name	City	State
Egypt	October 6 University Hospital	Al ?ayy Ath Thamin	Giza

Sponsors (1)

Lead Sponsor	Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in ulnar nerve conduction velocity from baseline and 5 weeks posttreatment	Measurement of how quickly an electrical impulse moves along the nerve.	Changes in ulnar nerve conduction velocity from baseline and 5 weeks posttreatment
Secondary	Changes in pain intensity at 5 weeks posttreatment	pain (min-max:0-10) Higher scores correlate to higher intensity of pain	Changes in pain intensity from baseline and 5 weeks posttreatment
Secondary	Changes in function using QUICK DASH scale at 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 function using QUICK DASH scale from baseline and 5 weeks posttreatment