Cubital Tunnel SyndromeCTSNCT05931731
Mechanical Interference Versus Neural Mobilization on Ulnar Neuropathy Post Cubital Tunnel Syndrome
A study testing Mechanical interference, Neural mobilization and conventional treatment in people with Cubital Tunnel Syndrome, run by Cairo University.
Trial summary
this study will be conducted to compare between mechanical interference and neural mobilization on ulnar neuropathy post-cubital tunnel syndrome Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Cubital Tunnel Syndrome
- What is being tested?
- Mechanical interference, Neural mobilization and conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2023to 30 Dec 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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
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.
- Conditions
- Cubital Tunnel Syndrome
- Being tested
- Mechanical interference, Neural mobilization, conventional treatment
- Keywords
- mechanical interference, neural mobilization, ulnar neuropathy, post cubital syndrome
- Medical subject headings
- Cubital Tunnel Syndrome, Ulnar Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical interferenceOther
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
Neural mobilizationOther
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
conventional treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical interference | Experimental | the patients will receive mechanical interference and conventional treatment three times a week for four weeks Receives: Other: Mechanical interference; Other: conventional treatment |
| Neural mobilization | Experimental | the patients will receive neural mobilization and conventional treatment three times a week for four weeks Receives: Other: Neural mobilization; Other: conventional treatment |
| conventional treatment | Active comparator | the patients will receive conventional treatment only three times a week for four weeks Receives: Other: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to four weeks
Secondary outcomes (3)
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.
Measured: up to four weeks
ulnar nerve sensory conduction velocity
electromyography device will be used for measuring ulnar nerve sensory conduction velocity
Measured: up to four weeks
ulnar nerve motor distal latency
electromyography device will be used for measuring ulnar nerve motor distal latency
Measured: up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start30 Jun 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- mechanical interference and neural mobilization
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed tarek Mohamed hefnawy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931731
- Sponsor's protocol ID
- P.T.REC/012/003083
- Acronym
- CTS
- Status last verified
- Jul 2023
- First submitted
- 24 Jun 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mechanical Interference Versus Neural Mobilization on Ulnar Neuropathy Post Cubital Tunnel Syndrome: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05931731
- Acronym / sponsor ID
- CTS / P.T.REC/012/003083
- Conditions
- Cubital Tunnel Syndrome
- Keywords
- mechanical interference, neural mobilization, ulnar neuropathy, post cubital syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jun 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 5 Jul 2023 (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 compare between mechanical interference and neural mobilization on ulnar neuropathy post-cubital tunnel syndrome
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- mechanical interference and neural mobilization
| Arm | Type | Receives |
|---|---|---|
| Mechanical interference | Experimental | Other: Mechanical interference, Other: conventional treatmentthe patients will receive mechanical interference and conventional treatment three times a week for four weeks |
| Neural mobilization | Experimental | Other: Neural mobilization, Other: conventional treatmentthe patients will receive neural mobilization and conventional treatment three times a week for four weeks |
| conventional treatment | Active comparator | Other: conventional treatmentthe patients will receive conventional treatment only three times a week for four weeks |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Mechanical interferenceThe 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 | Mechanical interference |
| Neural mobilizationthe 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 | Other | Neural mobilization |
| conventional treatmentthe 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 | Mechanical interference, Neural mobilization, conventional treatment |
Primary outcome
pain intensity
Time frame: up to four weeks
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).
3 secondary outcomes
function and severity
Time frame: up to four weeks
ulnar nerve sensory conduction velocity
Time frame: up to four weeks
ulnar nerve motor distal latency
Time frame: up to four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical interference, Neural mobilization and conventional treatment in people with Cubital Tunnel Syndrome, run by Cairo University.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
pain intensity (time frame: up to four weeks). 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 5 Jul 2023.