Cubital Tunnel SyndromeNCT05212311
Effect of Chitosan Phonophoresis On Cubital Tunnel Syndrome
A study testing Chitosan Phonophoresis, Therapeutic Ultrasound and Splinting in people with Cubital Tunnel Syndrome and Ulnar Nerve Entrapment at Elbow, run by October 6 University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Cubital Tunnel Syndrome, Ulnar Nerve Entrapment at Elbow, Ulnar Nerve Compression
- What is being tested?
- Chitosan Phonophoresis, Therapeutic Ultrasound and Splinting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Mar 2022to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site
October 6 University Hospital
Al Ḩayy Ath Thāmin, Giza Governorate, 12611
About this study
Official title: 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.
- Conditions
- Cubital Tunnel Syndrome, Ulnar Nerve Entrapment at Elbow, Ulnar Nerve Compression, Ulnar Nerve Entrapment Syndrome
- Being tested
- Chitosan Phonophoresis, Therapeutic Ultrasound, Splinting, Neural mobilization exercises of the ulnar nerve
- Medical subject headings
- Cubital Tunnel Syndrome, Ulnar Nerve Compression Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chitosan PhonophoresisDevice
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 UltrasoundDevice
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.
SplintingDevice
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.
Neural mobilization exercises of the ulnar nerveOther
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
| Study group | Role | What they receive |
|---|---|---|
| Group A (Control group) | Active comparator | Group A (n=27) will receive a conventional physical therapy program only for 5 weeks in the form of Splinting, Ultrasound and Exercises. Receives: Device: Chitosan Phonophoresis; Device: Splinting; Other: Neural mobilization exercises of the ulnar nerve |
| Group B (Chitosan phonophoresis group) | Experimental | 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. Receives: Device: Therapeutic Ultrasound; Device: Splinting; Other: Neural mobilization exercises of the ulnar nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ulnar nerve conduction velocity from baseline and 5 weeks posttreatment
Measurement of how quickly an electrical impulse moves along the nerve.
Measured: Changes in ulnar nerve conduction velocity from baseline and 5 weeks posttreatment
Secondary outcomes (2)
Changes in pain intensity at 5 weeks posttreatment
pain (min-max:0-10) Higher scores correlate to higher intensity of pain
Measured: 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.
Measured: Changes in function using QUICK DASH scale from baseline and 5 weeks posttreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start8 Mar 2022
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cubital Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy Ali Hassan ElMeligie, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212311
- Sponsor's protocol ID
- CUTS001
- Status last verified
- Jun 2023
- First submitted
- 15 Jan 2022
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all of the individual participant data collected during the trial and after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chitosan Phonophoresis On Cubital Tunnel Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05212311
- Acronym / sponsor ID
- CUTS001
- Conditions
- Cubital Tunnel Syndrome, Ulnar Nerve Entrapment at Elbow, Ulnar Nerve Compression, Ulnar Nerve Entrapment Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Control group) | Active comparator | Device: Chitosan Phonophoresis, Device: Splinting, Other: Neural mobilization exercises of the ulnar nerveGroup 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) | Experimental | Device: Therapeutic Ultrasound, Device: Splinting, Other: Neural mobilization exercises of the ulnar nervePatients 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chitosan PhonophoresisTherapeutic 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 | Group A (Control group) |
| Therapeutic UltrasoundUS 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. | Device | Group B (Chitosan phonophoresis group) |
| SplintingSplinting 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. | Device | Group A (Control group), Group B (Chitosan phonophoresis group) |
| Neural mobilization exercises of the ulnar nerveNerve 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 | Other | Group A (Control group), Group B (Chitosan phonophoresis group) |
Primary outcome
Changes in ulnar nerve conduction velocity from baseline and 5 weeks posttreatment
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.
2 secondary outcomes
Changes in pain intensity at 5 weeks posttreatment
Time frame: Changes in pain intensity from baseline and 5 weeks posttreatment
Changes in function using QUICK DASH scale at 5 weeks posttreatment
Time frame: Changes in function using QUICK DASH scale from baseline and 5 weeks posttreatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: Yes. all of the individual participant data collected during the trial and after deidentification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chitosan Phonophoresis, Therapeutic Ultrasound and Splinting in people with Cubital Tunnel Syndrome and Ulnar Nerve Entrapment at Elbow, run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in ulnar nerve conduction velocity from baseline and 5 weeks posttreatment (time frame: Changes in ulnar nerve conduction velocity from baseline and 5 weeks posttreatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.