Physical and Rehabilitation MedicineNCT04690959
Comparative Effects of Tensioning and Sliding Neural Mobilization on Nerve Root Function
A study testing neural mobilization in people with Physical and Rehabilitation Medicine, run by University of Sharjah at 2 sites in United Arab Emirates.
Trial summary
the current study will try to answer the question: Is it theoretically possible, that increased longitudinal stress on nerve root from sliding or tensioning intervention may subtly affect the neural function? Our hypothesis is that tensioning and sliding, differently affect the neural function. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical and Rehabilitation Medicine
- What is being tested?
- neural mobilization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesUnited Arab Emirates
- Study dates
- 1 Jan 2021to 22 Jan 2021
- 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 30 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
2 sites in 1 country.
United Arab Emirates2 sites
Ibrahim Moustafa
Sharjah city, United Arab Emirate, 27272
University of Sharjah
Sharjah city, 27272
About this study
Official title: Comparative Effects of Tensioning and Sliding Neural Mobilization on Nerve Root Function :Randomized Controlled Trial
the current study will try to answer the question: Is it theoretically possible, that increased longitudinal stress on nerve root from sliding or tensioning intervention may subtly affect the neural function? Our hypothesis is that tensioning and sliding, differently affect the neural function.
Read the detailed description
A prospective, parallel randomized, controlled study will be conducted at a research laboratory of our University. Participant recruitment will begin following approval from the Ethics Committee .The patients will participate in the study after signing an informed consent form prior to data collection.
Per inclusion criteria, subjects will be between 18 and 50 years of age, not currently experiencing any neck or dominant upper extremity symptoms, do not have a history significant for a chronic painful condition, and will not using pain relievers. Prior to participating in any study-related procedures, participants will read and signed an informed consent form approved by the Institutional Review Board.
Participants will be divided into three groups; One group will receive neural gliding mobilization and the other neural tensioning mobilization, both targeting the median nerve.
. the third group will receive sham neural mobilization intervention . Participants were not given information on which neural mobilization technique they were receiving; they were only told that they could receive one of two different neural mobilization techniques. Six sessions will be given every other day for 2 weeks.
- Conditions
- Physical and Rehabilitation Medicine
- Being tested
- neural mobilization, Sham intervention
- 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.
neural mobilizationOther
Also called neurodynamics
Neural mobilization, or neurodynamics, is a movement-based intervention aimed at restoring the homeostasis in and around the nervous system.
Sham interventionOther
it is faked neural mobilization that mimic the neural mobilization treatment but believed not to stress the neural tissues in the upper extremity.
| Study group | Role | What they receive |
|---|---|---|
| Neural gliding mobilization | Experimental | Initial participant positioning for gliding will be : lying in supine, shoulder at approximately 90 of abduction, wrist in neutral, elbow at 90 flexion and head/neck neutral. From this starting position, participants actively and simultaneously will perform extension of the elbow (to 45) and ipsilateral neck flexion (to approximately 45) and then returned to 90 of elbow flexion and 45 of contralateral neck flexion while maintaining the shoulder at 90 abduction. According to Silva et al., (2014) this combination of movements was the one that promoted the greatest excursion of the median nerve (10.2 mm) . For gliding, four series of 10 movements at a rhythm of approximately 6 s per cycle and 1-min rest between series was performed. Receives: Other: neural mobilization |
| Neural tensioning mobilization | Experimental | Tensioning will be performed with the subject lying supine. The investigator will perform the upper limb neurodynamic test as reported by Butler (2000): shoulder depression; 110 of shoulder abduction; external shoulder rotation; wrist and fingers extension; forearm supination and then elbow extension. The final test position will be defined as either i) end of joint amplitude or ii) the joint amplitude that provokes pain, paresthesia or numbness. In this case, a decrease of 5 to 10 of range of motion (elbow extension) will be allowed for symptoms to disappear and from this end position the investigator will perform repetitive movements of approximately 10 of elbow flexion/extension while maintaining the test end position for all the other joints. For tensioning, four series of 10 movements at a rhythm of approximately 6 s per cycle and 1-min rest between series will be performed. After each cycle of 10 repetitions, the position will be held for 10 seconds. Receives: Other: neural mobilization |
| Control | Sham comparator | Participants in the sham group will receive a treatment consisting of maneuvers that mimic the neural mobilization treatment but not to stress the neural tissues in the upper extremity. The sham mobilization consists of passively positioning the participants in the following consecutive positions: (1) a neutral cervical spine (0° of lateral flexion), (2) 45°of shoulder abduction without scapula depression, and (3) 45° of shoulder external rotation combined with 45° of elbow flexion with forearm pronation. This will be immediately followed by 10 cycles of passive wrist flexion/extension at a rate of approximately 6 seconds per cycle (3 seconds into extension and 3 seconds into flexion) . Upon moving from wrist flexion to extension, an initial sense of resistance will be used as a sign to alternate directions. Following the 10th cycle, a static hold will be maintained while in wrist flexion for 10 seconds. Receives: Other: Sham intervention |
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 L3,L4,L5, S1 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) , 2 weeks ,through study completion, an average of 1 week
Secondary outcomes (2)
Change in Skin Sympathetic response
For measurement of the Skin Sympathetic response, electromyography equipment will be used. The skin temperature will be maintained at 32° )by making the stability of room temperature around 26° C, asking subjects to stay in the room for 20 minutes with that temperature before the examination and prevent local warm-up for extremities) . Active surface electrodes will be attached on the palmar side, and the references will be placed on the dorsum of the hand. The stimulus will be given at the wrist contralateral to the recording side. The latency and peak to peak amplitude will be determined. Sympathetic skin response will be considered absent if there is no response after ten stimuli.
Measured: baseline (pre-treatment) , 2 weeks ,through study completion, an average of 1 week
Change in Pressure pain threshold
An algometer will be used to measure Pressure pain threshold at both the thenar eminence and the proximal third of the right ventral forearm. . Before measurements on these points will be taken, Pressure pain threshold measurement will be demonstrated in the opposite upper limb to familiarize the patient with the procedure. Participants will be instructed to say "stop" when the sensation changed from pressure to pain. The Pressure pain threshold will be measured with the patient's hand and forearm in supination and supported on a table. Three measurements will be taken at each point. The mean value was used for between groups comparisons. A 30-second resting period will be allowed between each measurement. The pressure will be applied at a rate of 3 N/s up to a maximum of 60 N, which was not exceeded because of the risk of tissue damage.
Measured: baseline (pre-treatment) , 2 weeks of treatment and at 1 week following the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 Jan 2021
- Primary completion14 Jan 2021
- Study completion22 Jan 2021
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, parallel-group, randomized clinical trial participants will be randomly assigned to the control group or one of the 2 intervention groups. One group received neural gliding mobilization and the other neural tensioning mobilization, both targeting the median nerve
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
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 Moustafa, associate professor, Principal investigator, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690959
- Sponsor's protocol ID
- USharjah 2021
- Status last verified
- Feb 2021
- First submitted
- 26 Dec 2020
- Last updated
- 2 Mar 2021
- 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 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Tensioning and Sliding Neural Mobilization on Nerve Root Function :Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04690959
- Acronym / sponsor ID
- USharjah 2021
- Conditions
- Physical and Rehabilitation Medicine
- Keywords
- Randomized controlled trial, Neurodynamics, evoked potential, somatosensory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 22 Jan 2021 (actual)
- First posted
- 31 Dec 2020 (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 current study will try to answer the question: Is it theoretically possible, that increased longitudinal stress on nerve root from sliding or tensioning intervention may subtly affect the neural function? Our hypothesis is that tensioning and sliding, differently affect the neural function.
Detailed description
A prospective, parallel randomized, controlled study will be conducted at a research laboratory of our University. Participant recruitment will begin following approval from the Ethics Committee .The patients will participate in the study after signing an informed consent form prior to data collection.
Per inclusion criteria, subjects will be between 18 and 50 years of age, not currently experiencing any neck or dominant upper extremity symptoms, do not have a history significant for a chronic painful condition, and will not using pain relievers. Prior to participating in any study-related procedures, participants will read and signed an informed consent form approved by the Institutional Review Board.
Participants will be divided into three groups; One group will receive neural gliding mobilization and the other neural tensioning mobilization, both targeting the median nerve.
. the third group will receive sham neural mobilization intervention . Participants were not given information on which neural mobilization technique they were receiving; they were only told that they could receive one of two different neural mobilization techniques. Six sessions will be given every other day for 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- A prospective, parallel-group, randomized clinical trial participants will be randomly assigned to the control group or one of the 2 intervention groups. One group received neural gliding mobilization and the other neural tensioning mobilization, both targeting the median nerve
| Arm | Type | Receives |
|---|---|---|
| Neural gliding mobilization | Experimental | Other: neural mobilizationInitial participant positioning for gliding will be : lying in supine, shoulder at approximately 90 of abduction, wrist in neutral, elbow at 90 flexion and head/neck neutral. From this starting position, participants actively and simultaneously will perform extension of the elbow (to 45) and ipsilateral neck flexion (to approximately 45) and then returned to 90 of elbow flexion and 45 of contralateral neck flexion while maintaining the shoulder at 90 abduction. According to Silva et al., (2014) this combination of movements was the one that promoted the greatest excursion of the median nerve (10.2 mm) . For gliding, four series of 10 movements at a rhythm of approximately 6 s per cycle and 1-min rest between series was performed. |
| Neural tensioning mobilization | Experimental | Other: neural mobilizationTensioning will be performed with the subject lying supine. The investigator will perform the upper limb neurodynamic test as reported by Butler (2000): shoulder depression; 110 of shoulder abduction; external shoulder rotation; wrist and fingers extension; forearm supination and then elbow extension. The final test position will be defined as either i) end of joint amplitude or ii) the joint amplitude that provokes pain, paresthesia or numbness. In this case, a decrease of 5 to 10 of range of motion (elbow extension) will be allowed for symptoms to disappear and from this end position the investigator will perform repetitive movements of approximately 10 of elbow flexion/extension while maintaining the test end position for all the other joints. For tensioning, four series of 10 movements at a rhythm of approximately 6 s per cycle and 1-min rest between series will be performed. After each cycle of 10 repetitions, the position will be held for 10 seconds. |
| Control | Sham comparator | Other: Sham interventionParticipants in the sham group will receive a treatment consisting of maneuvers that mimic the neural mobilization treatment but not to stress the neural tissues in the upper extremity. The sham mobilization consists of passively positioning the participants in the following consecutive positions: (1) a neutral cervical spine (0° of lateral flexion), (2) 45°of shoulder abduction without scapula depression, and (3) 45° of shoulder external rotation combined with 45° of elbow flexion with forearm pronation. This will be immediately followed by 10 cycles of passive wrist flexion/extension at a rate of approximately 6 seconds per cycle (3 seconds into extension and 3 seconds into flexion) . Upon moving from wrist flexion to extension, an initial sense of resistance will be used as a sign to alternate directions. Following the 10th cycle, a static hold will be maintained while in wrist flexion for 10 seconds. |
Who may qualify
- Ages
- 18 to 30 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 |
|---|---|---|
| neural mobilizationAlso: neurodynamicsNeural mobilization, or neurodynamics, is a movement-based intervention aimed at restoring the homeostasis in and around the nervous system. | Other | Neural gliding mobilization, Neural tensioning mobilization |
| Sham interventionit is faked neural mobilization that mimic the neural mobilization treatment but believed not to stress the neural tissues in the upper extremity. | Other | Control |
Primary outcome
Change in dermatomal somatosensory evoked potentials
Time frame: baseline (pre-treatment) , 2 weeks ,through study completion, an average of 1 week
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 L3,L4,L5, S1 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.
2 secondary outcomes
Change in Skin Sympathetic response
Time frame: baseline (pre-treatment) , 2 weeks ,through study completion, an average of 1 week
Change in Pressure pain threshold
Time frame: baseline (pre-treatment) , 2 weeks of treatment and at 1 week following the end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- 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 Moustafa, associate professor principal investigator
University of Sharjah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neural mobilization in people with Physical and Rehabilitation Medicine, run by University of Sharjah at 2 sites in United Arab Emirates.
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: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Arab Emirates. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in dermatomal somatosensory evoked potentials (time frame: baseline (pre-treatment) , 2 weeks ,through study completion, an average of 1 week). 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 2 Mar 2021.