Mechanical Interference Versus Neural Mobilization on Ulnar Neuropathy Post Cubital Tunnel Syndrome (CTS)

Efficacy of Mechanical Interference Versus Neural Mobilization on Ulnar Neuropathy Post Cubital Tunnel Syndrome: A Randomized Clinical Trial

this study will be conducted to compare between mechanical interference and neural mobilization on ulnar neuropathy post-cubital tunnel syndrome

Study Overview

• Status: Not yet recruiting
• Conditions: Cubital Tunnel Syndrome
• Intervention / Treatment: Other: Mechanical interference; Other: conventional treatment; Other: Neural mobilization

Detailed Description

Ulnar nerve neuropathies are the second most common entrapment neuropathy of the upper extremities after carpal tunnel syndrome. Cubital tunnel syndrome (CTS) is a condition that involves pressure or stretching of the ulnar nerve also known as the "funny bone" nerve, which could cause numbness or tingling in the ring and tiny fingers, pain in the forearm, and hand weakness. The ulnar nerve runs in a groove on the inner side of the elbow. Conservative treatment of cubital tunnel syndrome is recommended for patients with mild and moderate symptoms and without changes in cutaneous sensation or muscle atrophy. In addition, a wide variety of conservative approaches including corticosteroid injections as a minimally invasive technique and splinting and bracing failure were recommended for CTS depending on its severity. Manual therapy techniques are part of the physical therapy treatment of CTS, which are classified into two groups including nerve mobilization and mechanical interface mobilization. The aim of the study was to find which manual therapy method-technique directed to mechanical interface and nerve mobilization-has superior beneficial effects on clinical and electrophysiological findings in the conservative management of patients with CTS. Ninety patients with post-cubital syndrome will be allocated randomly to three groups; the first experimental one will receive mechanical interference, the second experimental will receive neural mobilization and the third one will receive conventional treatment for four weeks.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The patients were diagnosed and referred by an orthopedist.
• The patient's age ranged from 20 to 55 years old.
• Recent NCV for ulnar nerve confirming the diagnosis.
• Unilateral cubital tunnel syndrome with ulnar neuropathy

Exclusion Criteria:

• Patients with cervical brachialgia.
• Patients with metabolic diseases such as diabetes, severe thyroid disorders, anemia, and -pregnancy.
• Hypertensive patients or patients who had a previous hand or elbow surgery.
• Patients with median nerve involvement in proximal areas such as thoracic outlet syndrome.

History of carpal tunnel release surgery. Steroid injection

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mechanical interference; the patients will receive mechanical interference and conventional treatment three times a week for four weeks	Other: Mechanical interference; The patients will receive mechanical interference treatment in the form of five techniques, including wrist distraction (3 sets for 3 minutes), rhythmic and gentle stretching of the transverse carpal ligaments, the release of palmar hand fascia, gliding of the finger flexor tendons (using the oscillatory flexion-extension movement of the metacarpophalangeal joint) and release of the upper forearm muscle and fascia were applied. Manual techniques were performed total of 15 minutes in each session each technique included 3 sets for 3 minutes and conventional treatment; Other: conventional treatment; the patients will receive therapeutic ultrasound (frequency of 1 MHz, intensity of 1 W/cm2, for 5 minutes), transcutaneous electrical nerve stimulation (TENS) (frequency of 80 Hz, pulse duration of 60 μs, at the level of comfortable tingling sensation, for 20 minutes) and therapeutic exercises.
Experimental: Neural mobilization; the patients will receive neural mobilization and conventional treatment three times a week for four weeks	Other: conventional treatment; the patients will receive therapeutic ultrasound (frequency of 1 MHz, intensity of 1 W/cm2, for 5 minutes), transcutaneous electrical nerve stimulation (TENS) (frequency of 80 Hz, pulse duration of 60 μs, at the level of comfortable tingling sensation, for 20 minutes) and therapeutic exercises.; Other: Neural mobilization; the patients will receive neurodynamic mobilizations, including sliding techniques and tensioning techniques which are thought to enhance ulnar nerve gliding and restore neural tissue mobility and conventional treatment
Active Comparator: conventional treatment; the patients will receive conventional treatment only three times a week for four weeks	Other: conventional treatment; the patients will receive therapeutic ultrasound (frequency of 1 MHz, intensity of 1 W/cm2, for 5 minutes), transcutaneous electrical nerve stimulation (TENS) (frequency of 80 Hz, pulse duration of 60 μs, at the level of comfortable tingling sensation, for 20 minutes) and therapeutic exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity	pain will be measured by visual analogue scale. it is a vertical or horizontal 100mm line graduated by different level of pain, starting from 0 (no pain) till 100 (worst pain).	up to four weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
function and severity	Boston Questionnaire will be used for assessing the function and severity of hand. The questionnaire including two parts, namely the symptom severity scale (SSS) and the functional status scale (FSS), is considered a standard tool to evaluate the patients with CTS. The SSS contains 11 questions on different symptoms of hand and FSS comprises of 5 questions assessing the difficulty in performing selected activities. The response to each question was scored from one (mildest) to five (most severe) points. The overall scores for SSS and FSS were calculated as the score sum of all questions.	up to four weeks
ulnar nerve sensory conduction velocity	electromyography device will be used for measuring ulnar nerve sensory conduction velocity	up to four weeks
ulnar nerve motor distal latency	electromyography device will be used for measuring ulnar nerve motor distal latency	up to four weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2023
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: June 24, 2023
• First Submitted That Met QC Criteria: July 1, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 1, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: neural mobilization; mechanical interference; ulnar neuropathy; post cubital syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Ulnar Nerve Compression Syndromes; Syndrome; Ulnar Neuropathies; Cubital Tunnel Syndrome
• Other Study ID Numbers: P.T.REC/012/003083

Drug and device information, study documents

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