Health Care AcceptorNCT06098131
Comparative Effects of the Neurodynamic Slider and Tensioner Mobilisation Techniques on Sympathetic Nervous System Function: A Randomised Controlled Trial
A study testing Neurodynamic in people with Health Care Acceptor, run by European University Cyprus at 1 site in Cyprus.
Trial summary
In accordance with an independently matched group design methodology, 90 healthy volunteers (aged 18 to 40) were enlisted and randomly assigned to one of three experimental groups (sliding, tension, or control groups). The participants' group assignment was concealed from them. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Care Acceptor
- What is being tested?
- Neurodynamic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCyprus
- Study dates
- 10 Sep 2021to 10 Oct 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
- Aged between 18 and 40 years
- Body Mass Index less than 30
Who cannot join
- Previous History of Lower Back Pain
- Skin Disorders
- Previous Experience of Spinal Manual Therapy Treatment
- Previous Lower Limb Injuries or Trauma
- Food, Caffeine, Nicotine, or Alcohol consumed 3 hours before the experiment strenuous Activity done 3 hours before the experiment
- Chronic Systemic Health Conditions (for example, diabetes)
- Psychiatric Illnesses or Anxiety Disorders
- Medication that may have an affect on the SNS (for example, anti-depressants, anti-nausea medication, beta-blockers, muscle relaxants)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of the Neurodynamic Slider and Tensioner Mobilisation Technique on Sympathetic Nervous System Function: A Randomised Controlled Trial
In accordance with an independently matched group design methodology, 90 healthy volunteers (aged 18 to 40) were enlisted and randomly assigned to one of three experimental groups (sliding, tension, or control groups). The participants' group assignment was concealed from them. Using the Biopac MP36 electrodermal amplifier, constant skin conductors (SC) levels were captured for 20 minutes. A blind data collector used the Biopac software to gather the data. A pre and post-treatment measurement was taken with the thermal-camera and an ambulatory blood pressure monitor.
Read the detailed description
Ninety healthy volunteer participants were randomly allocated to three groups (sliding neurodynamic techniques (NDT), tension NDT, and control) using the hypothetico-deductive method of theory testing that allows the comparison within the variables. Additionally, a double-blind experimental research strategy was used in this study. The study's participants were not informed on their allocation to the groups in an effort to reduce the likelihood of expectation bias. It is crucial to note that the researcher maintained his or her blindness throughout the data selection process in order to safeguard the study's internal validity. Two people carried out the experiment in order to accomplish this: the "therapist" who applied the NDT and the "data collector" in charge of documenting the outcomes of the intervention.
Any changes in the Sympathetic Nervous System (SNS) were noted and recorded using three valuable outcome measure tools: the Biopac Galvanic skin response 100B electrodermal activity amplifier (MP36 Biopac Systems Incorporation), a thermo-camera © and an ambulatory blood pressure monitor.
The practical room was set up during the experiment so that neither the therapist nor the subjects came in contact with the apparatus. In order to ensure blinding from the results as the experiment was running, the plinth (treatment area) was separated from the data collection table with the computer and equipment (Biopac, blood pressure monitor, environmental thermometer, and thermo-camera) by a screen. Only the data collector has access to the Biopac software, blood pressure monitor, environmental thermometer, and thermo-camera in order to blind the therapist to the results of the experiment completely. Throughout the whole experiment, the therapist stayed hidden behind the screen.
The therapist begins standardising the equipment when the subjects are seated on the plinth. The thermo-camera has to be positioned correctly, pointing at the participant's hold body in the first stage. Second, the therapist placed the blood pressure monitor's cuff on the participant's left arm. The ideal placement of the skin electrodes was the next step. Each participant's second and third toes on both legs received skin electrodes. When the participant finally assumed their position, the therapist asked the data collector to quickly verify SC activity using the thermo-camera, ambulatory blood pressure monitor, and graph readings from the Biopac acquisition programme.
The experiment comprised three phases: (1) Pre-Intervention Phase, (2) Intervention Phase, and (3) Post-Intervention Phase. The experiment started with an 8-minute stabilisation phase aiming to achieve a physiological resting state, followed by the baseline recording period, which lasted 2 minutes. During this phase, the therapist took the body temperature and the blood pressure of each participant, using the blood pressure monitor and the thermo-camera ©. Following, three phases of 1-minute interventions were applied on the 'intervention leg', each separated by a 1-minute rest period. Finally, the experiment concluded with a 5-minute resting period. The SC was recorded through the Biopac software the whole time, and the whole experiment lasted 20 minutes. Throughout the experiment, the data collector indicated the time frame for each phase with the verbal cue 'Intervention Phase 1 or 2 or 3'.
Moreover, the data collector placed markers on the Biopac graph to demonstrate the start and end of each intervention phase. Finally, when the experiment passed into the Post-Intervention Phase, the therapist took the body temperature and the blood pressure from each participant. It must be noted that NDT manoeuvres during the experiment were performed on the participants as described by Shacklock (2005).
- Conditions
- Health Care Acceptor
- Being tested
- Neurodynamic
- Keywords
- Neurodynamic, Neuromobilisation, Tensioner Neurodynamic Technique, Slider Neurodynamic Technique, Slump Test
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurodynamicOther
Neurodynamic Slider and Tensioner Technique
| Study group | Role | What they receive |
|---|---|---|
| Sliding Technique Group | Experimental | Participants in the sliding technique group first adopted the SSP. The therapist main-tained the head in a less flexed and closer to neutral position. During this process, they performed full dorsiflexion of the foot, ensuring that the movements allowed the nerve to glide through its pathway rather than creating significant tension Receives: Other: Neurodynamic |
| Tension Technique Group | Experimental | Participants in the tensioner technique group first adopted the SSP, then proceeded to enhance neural tension by simultaneously fully dorsiflexing the foot and fully flexing the cervical spine forward, thereby increasing tension throughout the nerve pathway. The technique is applied dynamically with relaxation intervals to prevent any potential negative effects on neural vasculature Receives: Other: Neurodynamic |
| Control Group | No intervention | In this group the participants will be requested to position themselves on the plinth in supine line position. All participants in this group will not receive any intervention and they will be instructed to remain in this position for 20 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biopac Galvanic skin response 100B electrodermal activity amplifier (MP36 Biopac Systems Incorporation)
The skin electrodes were placed on the 2nd and 3rd toes on both legs of each participant. Aiming to be sure of the maximum contact of the pads sticking on the skin, the ventral surfaces on the 2nd and 3rd toes were initially cleaned with an isopropyl alcohol tissue before the pads were placed. They remained for a few seconds to dry, aiming to remove any sweat residue or unwanted skin that might influence the data reading process.
Measured: 7 min continuously monitoring will take place during the intervention (7 min following the start of the experiment).
Thermo-Camera
Skin temperature will be measured using a thermo-camera (ThermaCam SC2000©, FLIR, Danderyd, Sweden) pre-post intervention. The thermo-camera will be positioned, pointing at the participant's entire body and monitoring the body temperature in degrees Celsius.
Measured: Monitoring will start when participants will take the final sympathetic slump position on the plinth before the intervention (4 min following the starting of the experiment) and following the intervention (20 min following the start of the experiment).
Ambulatory blood pressure monitoring
Therapist placed the cuff of an ambulatory blood pressure monitor (Omron© HEM-9210T Healthcare, Co, Ltd, Kyoto, Japan) on the left arm of the participant. The monitor was used to monitor pre and post-intervention systolic and diastolic blood pressure.
Measured: Monitoring will start when participants will take the final sympathetic slump position on the plinth before the intervension (3 min following the starting of the experiment) and following the intevension (18 min following the start of the experiment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start10 Sep 2021
- Primary completion10 Sep 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care AcceptorStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- European University Cyprus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charalambos Papacharalambous, European University Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098131
- Sponsor's protocol ID
- EEBK/EΠ/2021/58
- Status last verified
- Aug 2024
- First submitted
- 11 Oct 2023
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of the Neurodynamic Slider and Tensioner Mobilisation Technique on Sympathetic Nervous System Function: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06098131
- Acronym / sponsor ID
- EEBK/EΠ/2021/58
- Conditions
- Health Care Acceptor
- Keywords
- Neurodynamic, Neuromobilisation, Tensioner Neurodynamic Technique, Slider Neurodynamic Technique, Slump Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- European University CyprusUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 10 Sep 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 24 Oct 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.
In accordance with an independently matched group design methodology, 90 healthy volunteers (aged 18 to 40) were enlisted and randomly assigned to one of three experimental groups (sliding, tension, or control groups). The participants' group assignment was concealed from them. Using the Biopac MP36 electrodermal amplifier, constant skin conductors (SC) levels were captured for 20 minutes. A blind data collector used the Biopac software to gather the data. A pre and post-treatment measurement was taken with the thermal-camera and an ambulatory blood pressure monitor.
Detailed description
Ninety healthy volunteer participants were randomly allocated to three groups (sliding neurodynamic techniques (NDT), tension NDT, and control) using the hypothetico-deductive method of theory testing that allows the comparison within the variables. Additionally, a double-blind experimental research strategy was used in this study. The study's participants were not informed on their allocation to the groups in an effort to reduce the likelihood of expectation bias. It is crucial to note that the researcher maintained his or her blindness throughout the data selection process in order to safeguard the study's internal validity. Two people carried out the experiment in order to accomplish this: the "therapist" who applied the NDT and the "data collector" in charge of documenting the outcomes of the intervention.
Any changes in the Sympathetic Nervous System (SNS) were noted and recorded using three valuable outcome measure tools: the Biopac Galvanic skin response 100B electrodermal activity amplifier (MP36 Biopac Systems Incorporation), a thermo-camera © and an ambulatory blood pressure monitor.
The practical room was set up during the experiment so that neither the therapist nor the subjects came in contact with the apparatus. In order to ensure blinding from the results as the experiment was running, the plinth (treatment area) was separated from the data collection table with the computer and equipment (Biopac, blood pressure monitor, environmental thermometer, and thermo-camera) by a screen. Only the data collector has access to the Biopac software, blood pressure monitor, environmental thermometer, and thermo-camera in order to blind the therapist to the results of the experiment completely. Throughout the whole experiment, the therapist stayed hidden behind the screen.
The therapist begins standardising the equipment when the subjects are seated on the plinth. The thermo-camera has to be positioned correctly, pointing at the participant's hold body in the first stage. Second, the therapist placed the blood pressure monitor's cuff on the participant's left arm. The ideal placement of the skin electrodes was the next step. Each participant's second and third toes on both legs received skin electrodes. When the participant finally assumed their position, the therapist asked the data collector to quickly verify SC activity using the thermo-camera, ambulatory blood pressure monitor, and graph readings from the Biopac acquisition programme.
The experiment comprised three phases: (1) Pre-Intervention Phase, (2) Intervention Phase, and (3) Post-Intervention Phase. The experiment started with an 8-minute stabilisation phase aiming to achieve a physiological resting state, followed by the baseline recording period, which lasted 2 minutes. During this phase, the therapist took the body temperature and the blood pressure of each participant, using the blood pressure monitor and the thermo-camera ©. Following, three phases of 1-minute interventions were applied on the 'intervention leg', each separated by a 1-minute rest period. Finally, the experiment concluded with a 5-minute resting period. The SC was recorded through the Biopac software the whole time, and the whole experiment lasted 20 minutes. Throughout the experiment, the data collector indicated the time frame for each phase with the verbal cue 'Intervention Phase 1 or 2 or 3'.
Moreover, the data collector placed markers on the Biopac graph to demonstrate the start and end of each intervention phase. Finally, when the experiment passed into the Post-Intervention Phase, the therapist took the body temperature and the blood pressure from each participant. It must be noted that NDT manoeuvres during the experiment were performed on the participants as described by Shacklock (2005).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sliding Technique Group | Experimental | Other: NeurodynamicParticipants in the sliding technique group first adopted the SSP. The therapist main-tained the head in a less flexed and closer to neutral position. During this process, they performed full dorsiflexion of the foot, ensuring that the movements allowed the nerve to glide through its pathway rather than creating significant tension |
| Tension Technique Group | Experimental | Other: NeurodynamicParticipants in the tensioner technique group first adopted the SSP, then proceeded to enhance neural tension by simultaneously fully dorsiflexing the foot and fully flexing the cervical spine forward, thereby increasing tension throughout the nerve pathway. The technique is applied dynamically with relaxation intervals to prevent any potential negative effects on neural vasculature |
| Control Group | No intervention | –In this group the participants will be requested to position themselves on the plinth in supine line position. All participants in this group will not receive any intervention and they will be instructed to remain in this position for 20 minutes. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged between 18 and 40 years
- Body Mass Index less than 30
Key exclusion criteria (8 listed)
- Previous History of Lower Back Pain
- Skin Disorders
- Previous Experience of Spinal Manual Therapy Treatment
- Previous Lower Limb Injuries or Trauma
- Food, Caffeine, Nicotine, or Alcohol consumed 3 hours before the experiment strenuous Activity done 3 hours before the experiment
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 |
|---|---|---|
| NeurodynamicNeurodynamic Slider and Tensioner Technique | Other | Sliding Technique Group, Tension Technique Group |
Primary outcome
Biopac Galvanic skin response 100B electrodermal activity amplifier (MP36 Biopac Systems Incorporation)
Time frame: 7 min continuously monitoring will take place during the intervention (7 min following the start of the experiment).
The skin electrodes were placed on the 2nd and 3rd toes on both legs of each participant. Aiming to be sure of the maximum contact of the pads sticking on the skin, the ventral surfaces on the 2nd and 3rd toes were initially cleaned with an isopropyl alcohol tissue before the pads were placed. They remained for a few seconds to dry, aiming to remove any sweat residue or unwanted skin that might influence the data reading process.
Thermo-Camera
Time frame: Monitoring will start when participants will take the final sympathetic slump position on the plinth before the intervention (4 min following the starting of the experiment) and following the intervention (20 min following the start of the experiment).
Skin temperature will be measured using a thermo-camera (ThermaCam SC2000©, FLIR, Danderyd, Sweden) pre-post intervention. The thermo-camera will be positioned, pointing at the participant's entire body and monitoring the body temperature in degrees Celsius.
Ambulatory blood pressure monitoring
Time frame: Monitoring will start when participants will take the final sympathetic slump position on the plinth before the intervension (3 min following the starting of the experiment) and following the intevension (18 min following the start of the experiment).
Therapist placed the cuff of an ambulatory blood pressure monitor (Omron© HEM-9210T Healthcare, Co, Ltd, Kyoto, Japan) on the left arm of the participant. The monitor was used to monitor pre and post-intervention systolic and diastolic blood pressure.
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 22 Aug 2024.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurodynamic in people with Health Care Acceptor, run by European University Cyprus at 1 site in Cyprus.
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 2 inclusion and 8 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 22 Aug 2024. 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 Cyprus. 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?
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?
Biopac Galvanic skin response 100B electrodermal activity amplifier (MP36 Biopac Systems Incorporation) (time frame: 7 min continuously monitoring will take place during the intervention (7 min following the start of the experiment).). 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 22 Aug 2024.