ClinicalTrials.gg
Not yet recruitingNCT05931731CTSUpdated Jul 5, 2023

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

An interventional study of Mechanical interference and Neural mobilization in Cubital Tunnel Syndrome, sponsored by Cairo University. Not yet recruiting. Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-07-05.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cubital Tunnel Syndrome

Keywords

  • mechanical interference
  • neural mobilization
  • ulnar neuropathy
  • post cubital syndrome
03

In context

Cubital Tunnel Syndrome

35 studies on the registry are indexed under Cubital Tunnel Syndrome; 6 are open to participants now.

This study's planned enrollment of 90 is above the median of 65 across 25 interventional studies indexed under Cubital Tunnel Syndrome.

Browse Cubital Tunnel Syndrome studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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. injection

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Mechanical interference

    the patients will receive mechanical interference and conventional treatment three times a week for four weeks

    Other: Mechanical interference · Other: conventional treatment

  • Experimental
    Neural mobilization

    the patients will receive neural mobilization and conventional treatment three times a week for four weeks

    Other: Neural mobilization · Other: conventional treatment

  • Active comparator
    conventional treatment

    the patients will receive conventional treatment only three times a week for four weeks

    Other: conventional treatment

Interventions

  • OtherMechanical 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

  • OtherNeural 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

  • Otherconventional 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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: up to four weeks

Secondary outcomes

  1. 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.

    Time frame: up to four weeks

  2. ulnar nerve sensory conduction velocity

    electromyography device will be used for measuring ulnar nerve sensory conduction velocity

    Time frame: up to four weeks

  3. ulnar nerve motor distal latency

    electromyography device will be used for measuring ulnar nerve motor distal latency

    Time frame: up to four weeks

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2023; primary completion for Dec 2023, 6 months later.

Of 15 interventional studies with no phase under Cubital Tunnel Syndrome, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 48. This study's planned 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 24, 2023
First posted
Jul 5, 2023
StartEst.
Jun 30, 2023
Primary completionEst.
Dec 30, 2023
CompletionEst.
Dec 30, 2023
Last update
Jul 5, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05931731
Lead sponsor
Cairo University
Responsible party
Mohamed tarek Mohamed hefnawy (principle investigator mohamed tarek mohamed hefnawy, Cairo University) — Principal investigator
First posted
Jul 5, 2023
Start date
Jun 30, 2023 (estimated)
Primary completion
Dec 30, 2023 (estimated)
Completion
Dec 30, 2023 (estimated)
Last update
Jul 5, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion