Effect of Chitosan Phonophoresis On Cubital Tunnel Syndrome

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

- 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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Al Ḩayy Ath Thāmin, Giza, Egypt, 12611
      • October 6 University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A (Control group); Group A (n=27) will receive a conventional physical therapy program only for 5 weeks in the form of Splinting, Ultrasound and Exercises.	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.; Device: 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
Experimental: Group B (Chitosan phonophoresis group); 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.	Device: 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; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: October 6 University

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: January 15, 2022
• First Submitted That Met QC Criteria: January 15, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Neuromuscular Diseases; Neurodegenerative Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Cumulative Trauma Disorders; Sprains and Strains; Heredodegenerative Disorders, Nervous System; Nervous System Malformations; Polyneuropathies; Ulnar Neuropathies; Syndrome; Nerve Compression Syndromes; Charcot-Marie-Tooth Disease; Hereditary Sensory and Motor Neuropathy; Ulnar Nerve Compression Syndromes; Cubital Tunnel Syndrome; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hemostatics; Coagulants; Chelating Agents; Sequestering Agents; Chitosan
• Other Study ID Numbers: CUTS001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all of the individual participant data collected during the trial and after deidentification
• IPD Sharing Time Frame: 6 Months after study publication
• IPD Sharing Access Criteria: Email: mohamed.magdy.pt@o6u.edu.eg
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No