Median Nerve EntrapmentNCT05788471
Effect of Neurodynamic Mobilization on Median Nerve Conduction Velocity in Carpal Tunnel Syndrome
A study testing conventional Treatment and Neurodynamic mobilization in people with Median Nerve Entrapment and Carpal Tunnel Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to examine: 1. The effect of neurodynamic mobilization on the sensory and motor median nerve conduction velocity in carpal tunnel syndrome. 2. The effect of neurodynamic mobilization on the wrist pain in carpal tunnel syndrome. 3. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Median Nerve Entrapment, Carpal Tunnel Syndrome
- What is being tested?
- conventional Treatment and Neurodynamic mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 15 Aug 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Forty carpal tunnel syndrome patients.
- All participants referred from a physician.
- Their ages range from 20-50 years old.
- Both genders will participate in the study.
- Their BMI ranges between 18.5-24.9kg/m2.
- All participants have carpal tunnel syndrome at least in one hand.
- All participants suffering from mild to moderate carpal tunnel syndrome.
Who cannot join
- Previous or current disease or trauma that might affect one or both upper limbs.
- Metabolic diseases that might associated with entrapment neuropathy such as diabetes mellitus, thyroid diseases, and autoimmune diseases.
- Pregnant women.
- Participants with congenital hand deformities.
- History of hand surgery.
- Sever cases of carpal tunnel syndrome that suffering from weakness of hand grip and atrophy of thenar muscle.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine:
- The effect of neurodynamic mobilization on the sensory and motor median nerve conduction velocity in carpal tunnel syndrome.
- The effect of neurodynamic mobilization on the wrist pain in carpal tunnel syndrome.
- The effect of neurodynamic mobilization on the hand function in carpal tunnel syndrome.
Read the detailed description
The findings of this study will provide physiotherapists with information to know if neurodynamic mobilization techniques is effective on median nerve conduction velocity in carpal tunnel syndrome also this will improve our body of knowledge about the best modalities for treating carpal tunnel syndrome. The finding of this study may help carpal tunnel syndrome patients to avoid the exposing to complications as a result of compression of median nerve in carpal tunnel syndrome.
- Conditions
- Median Nerve Entrapment, Carpal Tunnel Syndrome
- Being tested
- conventional Treatment, Neurodynamic mobilization
- Medical subject headings
- Median Neuropathy, Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional TreatmentOther
It consists of Superficial heat, Ultrasound therapy and stretching exercise to lumbrical muscles of the hand.
Neurodynamic mobilizationOther
It is the mobilisation of the nervous system as an approach to physical treatment of pain. The treatment and or assessment relies on influencing pain physiology via the mechanical treatment of neural tissues and non-neural structures surrounding the nervous system.
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment group | Active comparator | Twenty patients will receive conventional treatment in the form of superficial heat, ultrasound with freq of 1 MHz, pulsed mode 1:4 for 5 min and stretching exercise to lumbrical muscles of the hand. Receives: Other: conventional Treatment |
| Neurodynamic mobilization therapy group | Experimental | Twenty patients will receive neurodynamic mobilization therapy (upper limb tension test 1) in addition to conventional treatment. Receives: Other: conventional Treatment; Other: Neurodynamic mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the change in nerve conduction velocity of the median nerve.
By using Electromyography apparatus measuring nerve conduction velocity of the median nerve. (motor and sensory in m/s)
Measured: at baseline and after 4 weeks of intervention
Assessing the change in wrist joint pain
By using Pressure pain threshold (PPT) is defined as the minimal amount of pressure that produces pain. A simple handheld pressure algometer (PA) with a spring is commonly used, although more sophisticated electrical devices with a strain or pneumatic pressure gauge have been developed. They hold the peak force or pressure (kp (kilopond) = 10 N, Newton = 100 kPa (kilopascal)) until tared, and some may also be connected to a computer and thus have continuous output. PPT measured with a probe 1.6 mm in diameter or larger reflects the tenderness of deep tissues as anesthesia of skin only affects the results of smaller probes.
Measured: at baseline and after 4 weeks of intervention
Assessing the change in functional activity of the hand
By using Modified DASH questionnaire will be used for functional activity of the hand. The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity/function level.
Measured: at baseline and after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion15 Jun 2023 (estimated)
- Study completion15 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Median Nerve EntrapmentStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raghda Ahmed Mohammed Ebrahim, Cairo University
- Investigators
- Raghda Ahmed, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788471
- Sponsor's protocol ID
- Raghda Ahmed_PhD
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neurodynamic Mobilization on Median Nerve Conduction Velocity in Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT05788471
- Acronym / sponsor ID
- Raghda Ahmed_PhD
- Conditions
- Median Nerve Entrapment, Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 15 Jun 2023 (estimated)
- Study completion
- 15 Aug 2023 (estimated)
- First posted
- 29 Mar 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.
The purpose of this study is to examine:
- The effect of neurodynamic mobilization on the sensory and motor median nerve conduction velocity in carpal tunnel syndrome.
- The effect of neurodynamic mobilization on the wrist pain in carpal tunnel syndrome.
- The effect of neurodynamic mobilization on the hand function in carpal tunnel syndrome.
Detailed description
The findings of this study will provide physiotherapists with information to know if neurodynamic mobilization techniques is effective on median nerve conduction velocity in carpal tunnel syndrome also this will improve our body of knowledge about the best modalities for treating carpal tunnel syndrome. The finding of this study may help carpal tunnel syndrome patients to avoid the exposing to complications as a result of compression of median nerve in carpal tunnel syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment group | Active comparator | Other: conventional TreatmentTwenty patients will receive conventional treatment in the form of superficial heat, ultrasound with freq of 1 MHz, pulsed mode 1:4 for 5 min and stretching exercise to lumbrical muscles of the hand. |
| Neurodynamic mobilization therapy group | Experimental | Other: conventional Treatment, Other: Neurodynamic mobilizationTwenty patients will receive neurodynamic mobilization therapy (upper limb tension test 1) in addition to conventional treatment. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Forty carpal tunnel syndrome patients.
- All participants referred from a physician.
- Their ages range from 20-50 years old.
- Both genders will participate in the study.
- Their BMI ranges between 18.5-24.9kg/m2.
Key exclusion criteria (6 listed)
- Previous or current disease or trauma that might affect one or both upper limbs.
- Metabolic diseases that might associated with entrapment neuropathy such as diabetes mellitus, thyroid diseases, and autoimmune diseases.
- Pregnant women.
- Participants with congenital hand deformities.
- History of hand surgery.
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 |
|---|---|---|
| conventional TreatmentIt consists of Superficial heat, Ultrasound therapy and stretching exercise to lumbrical muscles of the hand. | Other | Conventional treatment group, Neurodynamic mobilization therapy group |
| Neurodynamic mobilizationIt is the mobilisation of the nervous system as an approach to physical treatment of pain. The treatment and or assessment relies on influencing pain physiology via the mechanical treatment of neural tissues and non-neural structures surrounding the nervous system. | Other | Neurodynamic mobilization therapy group |
Primary outcome
Assessing the change in nerve conduction velocity of the median nerve.
Time frame: at baseline and after 4 weeks of intervention
By using Electromyography apparatus measuring nerve conduction velocity of the median nerve. (motor and sensory in m/s)
Assessing the change in wrist joint pain
Time frame: at baseline and after 4 weeks of intervention
By using Pressure pain threshold (PPT) is defined as the minimal amount of pressure that produces pain. A simple handheld pressure algometer (PA) with a spring is commonly used, although more sophisticated electrical devices with a strain or pneumatic pressure gauge have been developed. They hold the peak force or pressure (kp (kilopond) = 10 N, Newton = 100 kPa (kilopascal)) until tared, and some may also be connected to a computer and thus have continuous output. PPT measured with a probe 1.6 mm in diameter or larger reflects the tenderness of deep tissues as anesthesia of skin only affects the results of smaller probes.
Assessing the change in functional activity of the hand
Time frame: at baseline and after 4 weeks of intervention
By using Modified DASH questionnaire will be used for functional activity of the hand. The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity/function level.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
Raghda Ahmed principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional Treatment and Neurodynamic mobilization in people with Median Nerve Entrapment and Carpal Tunnel Syndrome, run by Cairo 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 7 inclusion and 6 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 29 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raghda Ahmed (+201225615248, rodynody88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the change in nerve conduction velocity of the median nerve. (time frame: at baseline and after 4 weeks of intervention). The study lists 3 primary outcomes in all. 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 29 Mar 2023.