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- 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chitosan Phonophoresis | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| October 6 University Hospital | Al Ḩayy Ath Thāmin | Giza Governorate | 12611 | Egypt |
all of the individual participant data collected during the trial and after deidentification
6 Months after study publication
Email: mohamed.magdy.pt@o6u.edu.eg
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| ID | Term |
|---|---|
| D020430 | Cubital Tunnel Syndrome |
| D017769 | Ulnar Nerve Compression Syndromes |
| ID | Term |
|---|---|
| D020424 | Ulnar Neuropathies |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D013165 | Splints |
| ID | Term |
|---|---|
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
| D016267 | External Fixators |
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| Therapeutic Ultrasound | Device | 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 | Device | 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 nerve | Other | 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 |
|
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 |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D009984 |
| Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D053831 | Surgical Fixation Devices |