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Effect of Chitosan Phonophoresis On Cubital Tunnel Syndrome

Primary Purpose

Cubital Tunnel Syndrome, Ulnar Nerve Entrapment at Elbow, Ulnar Nerve Compression

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Chitosan Phonophoresis
Therapeutic Ultrasound
Splinting
Neural mobilization exercises of the ulnar nerve
Sponsored by
October 6 University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cubital Tunnel Syndrome

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • October 6 University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A (Control group)

Group B (Chitosan phonophoresis group)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Changes in pain intensity at 5 weeks posttreatment
pain (min-max:0-10) Higher scores correlate to higher intensity of pain
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.

Full Information

First Posted
January 15, 2022
Last Updated
June 14, 2023
Sponsor
October 6 University
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1. Study Identification

Unique Protocol Identification Number
NCT05212311
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 8, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cubital Tunnel Syndrome, Ulnar Nerve Entrapment at Elbow, Ulnar Nerve Compression, Ulnar Nerve Entrapment Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (Control group)
Arm Type
Active Comparator
Arm Description
Group A (n=27) will receive a conventional physical therapy program only for 5 weeks in the form of Splinting, Ultrasound and Exercises.
Arm Title
Group B (Chitosan phonophoresis group)
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Chitosan Phonophoresis
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Therapeutic Ultrasound
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Splinting
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Neural mobilization exercises of the ulnar nerve
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in ulnar nerve conduction velocity from baseline and 5 weeks posttreatment
Description
Measurement of how quickly an electrical impulse moves along the nerve.
Time Frame
Changes in ulnar nerve conduction velocity from baseline and 5 weeks posttreatment
Secondary Outcome Measure Information:
Title
Changes in pain intensity at 5 weeks posttreatment
Description
pain (min-max:0-10) Higher scores correlate to higher intensity of pain
Time Frame
Changes in pain intensity from baseline and 5 weeks posttreatment
Title
Changes in function using QUICK DASH scale at 5 weeks posttreatment
Description
the quickdash is a validated outcome measure for hand function, scored 0-100 with higher scores indicating worse disability which is bad.
Time Frame
Changes in function using QUICK DASH scale from baseline and 5 weeks posttreatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Age ranging from 20-35. 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
Facility Information:
Facility Name
October 6 University Hospital
City
Al Ḩayy Ath Thāmin
State/Province
Giza
ZIP/Postal Code
12611
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Effect of Chitosan Phonophoresis On Cubital Tunnel Syndrome

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