Physical and Rehabilitation MedicineNCT05813002
Impact of Order of Movement on Nerve Root Function
A study testing standard neural mobilization, Distal to proximal neural mobilization and proximal to distal neural mobilization in people with Physical and Rehabilitation Medicine, run by University of Sharjah.
Trial summary
the main objective of this study is to investigate if different neurodynamic test sequencing of the median nerve has a different impact on median nerve root function. We hypothesized that the order of median nerve neurodynamic movements would influence peak-to-peak amplitude and latency. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical and Rehabilitation Medicine
- What is being tested?
- standard neural mobilization, Distal to proximal neural mobilization and proximal to distal neural mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to May 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- not currently experiencing any neck or dominant upper extremity symptoms.
- do not have a history significant for a chronic painful condition.
- do not using pain relievers.
Who cannot join
- inflammatory joint disease or other systemic pathologies.
- prior history of overt injury and surgery relating to the musculoskeletal system.
- disorder related to the spine and extremities.
- musculoskeletal pain in the last three months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Order of Movement on Nerve Root Function: A Neurophysiological Study With Implications for Neurodynamic Test Sequencing
the main objective of this study is to investigate if different neurodynamic test sequencing of the median nerve has a different impact on median nerve root function. We hypothesized that the order of median nerve neurodynamic movements would influence peak-to-peak amplitude and latency.
Read the detailed description
Neurodynamic concept is used clinically to normalize nerve mobility. It has been manifested in previous studies that neurodynamics have increased mobility by floss like movement of the nerve. Whereas in other studies it has been concluded that neurodynamic techniques has an effect in decreasing fibrous and adhesions between neural tissues and the surrounding tissues therefore giving an outcome of improved infrafasicular gliding.
The upper limb neurodynamic test has an effect to alter the mechanical loads on the nerve by changing its dimensions. For neurodynamic to be more effective, it requires a certain sequence.
The different order of movements will induce different duration of tension in which it will influence the nerve root function, which is needed to be investigated to check for the effectiveness. A previous study has found that the difference of sequence on median nerve, had caused a change on the distribution of the sensory response on the asymptomatic participants. The sensory responses were more prevalent during the neurodynamic of the median nerve when it was applied from a distal to proximal sequence . One of the main purposes of the order of sequences is to add more strain to the nerve segment to increase the sensitivity of the test.
Clinically it has been assumed that the different order of movements could possibly influence the level of strain on a certain nerve segment. When the standard sequence was compared with the distal-to-proximal sequence for the median nerve, there was no physiological difference obtained at the end of the test. In comparison, there was a larger strain in the distal-to-proximal sequence in comparison to the proximal-to-distal sequence observed. However, the longitudinal excursion collected data indicated that the start and end positions for all the three sequences were alike.
In terms of neurophysiological outcomes, in this study we will use the dermatomal somatosensory evoked potential as a primary outcome due to its reliability in comparison with other physiological outcomes. There is a literature gap in regard to the effect of the order of sequence on the median nerve on the nerve root function and this is what the study will focus on. We hypothesized that the order of movements of the median nerve neurodynamic will influence the peak-to-peak amplitude and the latency.
- Conditions
- Physical and Rehabilitation Medicine
- Being tested
- standard neural mobilization, Distal to proximal neural mobilization, proximal to distal neural mobilization
- Keywords
- Randomized controlled trial, Neurodynamics, Evoked potential, Somatosensory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard neural mobilizationOther
is a movement-based intervention aimed at restoring the homeostasis in and around the nervous system.
Distal to proximal neural mobilizationOther
is a distal to proximal movement-based intervention aimed at restoring the homeostasis in and around the nervous system.
proximal to distal neural mobilizationOther
is a proximal to distal movement-based intervention aimed at restoring the homeostasis in and around the nervous system.
| Study group | Role | What they receive |
|---|---|---|
| standard neurodynamic sequence | Active comparator | Participants in the first group will receive the standard neurodynamic sequence. The starting position for this sequence will be shoulder in extension with lateral rotation, elbow in full flexion and wrist in neutral position. Passively the shoulder is abducted till 90 degrees followed by wrist extension then ended by elbow extension. Ipsilateral movement of the head bending till 45 degrees with movement of the wrist towards the body for 10 repetitions Receives: Other: standard neural mobilization |
| Distal to proximal neurodynamic sequence | Active comparator | The second group participants will receive the distal to proximal neurodynamic sequence. For this sequence the starting position will be shoulder in full extension with lateral rotation, elbow fully extended and wrist in neutral position. the sequence will start with wrist extension, going to elbow extension, and ending with shoulder abduction. Ipsilateral movement of the head bending till 45 degrees with movement of the wrist towards the body for 10 repetitions Receives: Other: Distal to proximal neural mobilization |
| proximal to distal neurodynamic sequence | Active comparator | The participants in the third experimental group will receive the proximal to distal sequence which will start with shoulder abduction, elbow extension and then wrist extension. The starting position is shoulder in extension and laterally rotated, elbow in full flexion, and wrist in neutral position. The shoulder will be passively mobilized to 90 degrees of abduction, elbow into full extension and wrist in full extension. Ipsilateral movement of the head bending till 45 degrees with movement of the wrist towards the body for 10 repetitions Receives: Other: proximal to distal neural mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dermatomal somatosensory evoked potentials.
In all dermatomes, 2 complete recording runs will be undertaken during each session with averages of 250 to 1200 cortical responses from scalp surface recording electrodes (C3'-C4' in a 10-20 electrode configuration) of the contralateral scalp to the stimulated dermatomes being stimulated. The impedance of ground and scalp electrodes will be maintained at < 5 k Cutaneous areas of C5,C6,C7 sensory roots will be stimulated in lower limb with the electrical impulses of 0.2 ms duration, frequency of 3.3 Hz and intensity 3 times higher than the sensory threshold will be determined individually for each subject.
Measured: baseline (pre-treatment) and immediately after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study startApr 2023 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical and Rehabilitation MedicineStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, parallel-group, randomized clinical trial participants will be randomly assigned to one of three different groups. One group will receive the standard neural mobilization, the second group will receive Distal-Proximal neural mobilization, and the third group will receive Proximal-Distal neural mobilization, all targeting the median nerve.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Moustafa, University of Sharjah
- Investigators
- Ibrahim M moustafa, Professor, Principal investigator, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813002
- Sponsor's protocol ID
- REC-22-06-04-S
- Status last verified
- Apr 2023
- First submitted
- 1 Apr 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Order of Movement on Nerve Root Function: A Neurophysiological Study With Implications for Neurodynamic Test Sequencing
- ClinicalTrials.gov ID
- NCT05813002
- Acronym / sponsor ID
- REC-22-06-04-S
- Conditions
- Physical and Rehabilitation Medicine
- Keywords
- Randomized controlled trial, Neurodynamics, Evoked potential, Somatosensory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 14 Apr 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 main objective of this study is to investigate if different neurodynamic test sequencing of the median nerve has a different impact on median nerve root function. We hypothesized that the order of median nerve neurodynamic movements would influence peak-to-peak amplitude and latency.
Detailed description
Neurodynamic concept is used clinically to normalize nerve mobility. It has been manifested in previous studies that neurodynamics have increased mobility by floss like movement of the nerve. Whereas in other studies it has been concluded that neurodynamic techniques has an effect in decreasing fibrous and adhesions between neural tissues and the surrounding tissues therefore giving an outcome of improved infrafasicular gliding.
The upper limb neurodynamic test has an effect to alter the mechanical loads on the nerve by changing its dimensions. For neurodynamic to be more effective, it requires a certain sequence.
The different order of movements will induce different duration of tension in which it will influence the nerve root function, which is needed to be investigated to check for the effectiveness. A previous study has found that the difference of sequence on median nerve, had caused a change on the distribution of the sensory response on the asymptomatic participants. The sensory responses were more prevalent during the neurodynamic of the median nerve when it was applied from a distal to proximal sequence . One of the main purposes of the order of sequences is to add more strain to the nerve segment to increase the sensitivity of the test.
Clinically it has been assumed that the different order of movements could possibly influence the level of strain on a certain nerve segment. When the standard sequence was compared with the distal-to-proximal sequence for the median nerve, there was no physiological difference obtained at the end of the test. In comparison, there was a larger strain in the distal-to-proximal sequence in comparison to the proximal-to-distal sequence observed. However, the longitudinal excursion collected data indicated that the start and end positions for all the three sequences were alike.
In terms of neurophysiological outcomes, in this study we will use the dermatomal somatosensory evoked potential as a primary outcome due to its reliability in comparison with other physiological outcomes. There is a literature gap in regard to the effect of the order of sequence on the median nerve on the nerve root function and this is what the study will focus on. We hypothesized that the order of movements of the median nerve neurodynamic will influence the peak-to-peak amplitude and the latency.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A prospective, parallel-group, randomized clinical trial participants will be randomly assigned to one of three different groups. One group will receive the standard neural mobilization, the second group will receive Distal-Proximal neural mobilization, and the third group will receive Proximal-Distal neural mobilization, all targeting the median nerve.
| Arm | Type | Receives |
|---|---|---|
| standard neurodynamic sequence | Active comparator | Other: standard neural mobilizationParticipants in the first group will receive the standard neurodynamic sequence. The starting position for this sequence will be shoulder in extension with lateral rotation, elbow in full flexion and wrist in neutral position. Passively the shoulder is abducted till 90 degrees followed by wrist extension then ended by elbow extension. Ipsilateral movement of the head bending till 45 degrees with movement of the wrist towards the body for 10 repetitions |
| Distal to proximal neurodynamic sequence | Active comparator | Other: Distal to proximal neural mobilizationThe second group participants will receive the distal to proximal neurodynamic sequence. For this sequence the starting position will be shoulder in full extension with lateral rotation, elbow fully extended and wrist in neutral position. the sequence will start with wrist extension, going to elbow extension, and ending with shoulder abduction. Ipsilateral movement of the head bending till 45 degrees with movement of the wrist towards the body for 10 repetitions |
| proximal to distal neurodynamic sequence | Active comparator | Other: proximal to distal neural mobilizationThe participants in the third experimental group will receive the proximal to distal sequence which will start with shoulder abduction, elbow extension and then wrist extension. The starting position is shoulder in extension and laterally rotated, elbow in full flexion, and wrist in neutral position. The shoulder will be passively mobilized to 90 degrees of abduction, elbow into full extension and wrist in full extension. Ipsilateral movement of the head bending till 45 degrees with movement of the wrist towards the body for 10 repetitions |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- not currently experiencing any neck or dominant upper extremity symptoms.
- do not have a history significant for a chronic painful condition.
- do not using pain relievers.
Key exclusion criteria (4 listed)
- inflammatory joint disease or other systemic pathologies.
- prior history of overt injury and surgery relating to the musculoskeletal system.
- disorder related to the spine and extremities.
- musculoskeletal pain in the last three months
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 |
|---|---|---|
| standard neural mobilizationis a movement-based intervention aimed at restoring the homeostasis in and around the nervous system. | Other | standard neurodynamic sequence |
| Distal to proximal neural mobilizationis a distal to proximal movement-based intervention aimed at restoring the homeostasis in and around the nervous system. | Other | Distal to proximal neurodynamic sequence |
| proximal to distal neural mobilizationis a proximal to distal movement-based intervention aimed at restoring the homeostasis in and around the nervous system. | Other | proximal to distal neurodynamic sequence |
Primary outcome
Change in dermatomal somatosensory evoked potentials.
Time frame: baseline (pre-treatment) and immediately after the treatment
In all dermatomes, 2 complete recording runs will be undertaken during each session with averages of 250 to 1200 cortical responses from scalp surface recording electrodes (C3'-C4' in a 10-20 electrode configuration) of the contralateral scalp to the stimulated dermatomes being stimulated. The impedance of ground and scalp electrodes will be maintained at < 5 k Cutaneous areas of C5,C6,C7 sensory roots will be stimulated in lower limb with the electrical impulses of 0.2 ms duration, frequency of 3.3 Hz and intensity 3 times higher than the sensory threshold will be determined individually for each subject.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: No. no plan to make individual participant data (IPD) available to other researchers.
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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.
Ibrahim M moustafa, Professor principal investigator
University of Sharjah
Questions about this trial
What is this clinical trial studying?
A study testing standard neural mobilization, Distal to proximal neural mobilization and proximal to distal neural mobilization in people with Physical and Rehabilitation Medicine, run by University of Sharjah.
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 3 inclusion and 4 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 14 Apr 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?
Contact Ibrahim M [imoustafa], Professor (+971502180024 ext. 7513, iabuamr@sharjah.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dermatomal somatosensory evoked potentials. (time frame: baseline (pre-treatment) and immediately after the treatment). 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 14 Apr 2023.