Healthy IndividualsNCT03029260
Effects of Nervous System Mobilization
A study testing Neural mobilization - tension. and Neural mobilization - gliding in people with Healthy Individuals, run by Aveiro University at 1 site in Portugal.
Trial summary
This study aims to compare the effect of tension neural mobilization versus sliding neural mobilization of the peroneal nerve on the heat and cold threshold, on pressure pain threshold and on flexibility both in the dominant lower limb (subjected to mobilization) and the non-dominant lower limb (not subjected to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals
- What is being tested?
- Neural mobilization - tension. and Neural mobilization - gliding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2017to Dec 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- naïve to nervous system mobilization;
Who cannot join
- Any surgery or trauma in the previous 6 months; neurological, cardiorespiratory or rheumatic pathology; cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Nervous System Mobilization on Heat, Cold and Mechanical Pain Thresholds and Lower Limb Flexibility
This study aims to compare the effect of tension neural mobilization versus sliding neural mobilization of the peroneal nerve on the heat and cold threshold, on pressure pain threshold and on flexibility both in the dominant lower limb (subjected to mobilization) and the non-dominant lower limb (not subjected to mobilization) in healthy young participants.
Read the detailed description
Sixty young and healthy participants will be randomly allocated to receive tension neural mobilization (n=30) or sliding neural mobilization (n=30). Data on heat threshold, cold threshold, pressure pain threshold and lower limb flexibility will be collected before the intervention, immediately after the intervention and at least 24h after the intervention.
- Conditions
- Healthy Individuals
- Being tested
- Neural mobilization - tension., Neural mobilization - gliding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural mobilization - tension.Other
Neural mobilization in tension consists of using combinations of joint movement known to maximize the tension and lengthening of peripheral nervous structures.
The intervention will be delivered in one session only.
Neural mobilization - glidingOther
Gliding neural mobilization consists of using combinations of joint movement known to maximize the movement of the peripheral nerves in relation to adjacent structures.
The intervention will be delivered in one session only.
| Study group | Role | What they receive |
|---|---|---|
| Neural mobilization - tension | Experimental | It is anticipated that 30 participants will be in this group. They will receive tension type neural mobilization of the peroneal nerve in the dominant limb. This will consist of positioning the lower limb with inversion and plantar flexion of the ankle, extension of the knee and maximum flexion of the hip without pain. A physiotherapists will move the hip from this maximum position of flexion in direction to extension (for example if the participants reaches 80º of flexion the mobilization will be between 40º and 80º of flexion). Each participant will receive four series of 10 mobilizations with 1 minute rest between series. Receives: Other: Neural mobilization - tension. |
| Neural mobilization - sliding | Active comparator | It is anticipated that 30 participants will be in this group. They will receive sliding neural mobilization of the peroneal nerve in the dominant limb. Each participant will receive four series of 10 mobilizations with 1 minute rest between series of the following combination of movement: from ankle dorsiflexion, knee extension and hip extension to ankle plantarflexion, knee and hip flexion. Receives: Other: Neural mobilization - gliding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion of the Straight Leg Raising test
The hip is raised to maximum flexion and the degree of flexion is measured with universal goniometer
Measured: Baseline
Range of motion of the Straight Leg Raising test
The hip is raised to maximum flexion and the degree of flexion is measured with universal goniometer
Measured: Approximately 45 minutes after baseline measurements
Range of motion of the Straight Leg Raising test
The hip is raised to maximum flexion and the degree of flexion is measured with universal goniometer
Measured: At least 24 hours after baseline measurements
Secondary outcomes (9)
Heat threshold
This is measured with a QSense instrument, which has thermode that is attached to the skin. The temperature in this thermode increases or decreases (as per the protocol being used) and the participants is holding a device to stop the temperature to increase/decrease when he/she first perceives it. The temperature perceived is the test result.
Measured: Baseline
Heat threshold
This is measured with a QSense instrument, which has thermode that is attached to the skin. The temperature in this thermode increases or decreases (as per the protocol being used) and the participants is holding a device to stop the temperature to increase/decrease when he/she first perceives it. The temperature perceived is the test result.
Measured: Approximately 45 minutes after baseline measurements
Heat threshold
This is measured with a QSense instrument, which has thermode that is attached to the skin. The temperature in this thermode increases or decreases (as per the protocol being used) and the participants is holding a device to stop the temperature to increase/decrease when he/she first perceives it. The temperature perceived is the test result.
Measured: At least 24 hours after baseline measurements
Cold threshold
This is measured with a QSense instrument, which has thermode that is attached to the skin. The temperature in this thermode increases or decreases (as per the protocol being used) and the participants is holding a device to stop the temperature to increase/decrease when he/she first perceives it. The temperature perceived is the test result.
Measured: Baseline
Cold threshold
This is measured with a QSense instrument, which has thermode that is attached to the skin. The temperature in this thermode increases or decreases (as per the protocol being used) and the participants is holding a device to stop the temperature to increase/decrease when he/she first perceives it. The temperature perceived is the test result.
Measured: Approximately 45 minutes after baseline measurements
Cold threshold
This is measured with a QSense instrument, which has thermode that is attached to the skin. The temperature in this thermode increases or decreases (as per the protocol being used) and the participants is holding a device to stop the temperature to increase/decrease when he/she first perceives it. The temperature perceived is the test result.
Measured: At least 24 hours after baseline measurements
Pressure pain threshold
This is measured using a pressure pain algometer. Pressure is made with this device against a specific body region (upper and lateral part of the dominant foot) until the participants perceives that the pressure changes to pain. The amount of pressure that the participants perceives as being painful is the test result.
Measured: Baseline
Pressure pain threshold
This is measured using a pressure pain algometer. Pressure is made with this device against a specific body region (upper and lateral part of the dominant foot) until the participants perceives that the pressure changes to pain. The amount of pressure that the participants perceives as being painful is the test result.
Measured: Approximately 45 minutes after baseline measurements
Pressure pain threshold
This is measured using a pressure pain algometer. Pressure is made with this device against a specific body region (upper and lateral part of the dominant foot) until the participants perceives that the pressure changes to pain. The amount of pressure that the participants perceives as being painful is the test result.
Measured: At least 24 hours after baseline measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJul 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anabela G Silva, Aveiro University
- Investigators
- Anabela Silva, PhD, Principal investigator, University of aveiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029260
- Sponsor's protocol ID
- NSM01
- Status last verified
- Apr 2018
- First submitted
- 19 Jan 2017
- Last updated
- 5 Apr 2018
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nervous System Mobilization on Heat, Cold and Mechanical Pain Thresholds and Lower Limb Flexibility
- ClinicalTrials.gov ID
- NCT03029260
- Acronym / sponsor ID
- NSM01
- Conditions
- Healthy Individuals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 24 Jan 2017 (estimated)
- 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 aims to compare the effect of tension neural mobilization versus sliding neural mobilization of the peroneal nerve on the heat and cold threshold, on pressure pain threshold and on flexibility both in the dominant lower limb (subjected to mobilization) and the non-dominant lower limb (not subjected to mobilization) in healthy young participants.
Detailed description
Sixty young and healthy participants will be randomly allocated to receive tension neural mobilization (n=30) or sliding neural mobilization (n=30). Data on heat threshold, cold threshold, pressure pain threshold and lower limb flexibility will be collected before the intervention, immediately after the intervention and at least 24h after the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neural mobilization - tension | Experimental | Other: Neural mobilization - tension.It is anticipated that 30 participants will be in this group. They will receive tension type neural mobilization of the peroneal nerve in the dominant limb. This will consist of positioning the lower limb with inversion and plantar flexion of the ankle, extension of the knee and maximum flexion of the hip without pain. A physiotherapists will move the hip from this maximum position of flexion in direction to extension (for example if the participants reaches 80º of flexion the mobilization will be between 40º and 80º of flexion). Each participant will receive four series of 10 mobilizations with 1 minute rest between series. |
| Neural mobilization - sliding | Active comparator | Other: Neural mobilization - glidingIt is anticipated that 30 participants will be in this group. They will receive sliding neural mobilization of the peroneal nerve in the dominant limb. Each participant will receive four series of 10 mobilizations with 1 minute rest between series of the following combination of movement: from ankle dorsiflexion, knee extension and hip extension to ankle plantarflexion, knee and hip flexion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- naïve to nervous system mobilization;
Key exclusion criteria (1 listed)
- Any surgery or trauma in the previous 6 months; neurological, cardiorespiratory or rheumatic pathology; cancer.
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 mobilization - tension.Neural mobilization in tension consists of using combinations of joint movement known to maximize the tension and lengthening of peripheral nervous structures. The intervention will be delivered in one session only. | Other | Neural mobilization - tension |
| Neural mobilization - glidingGliding neural mobilization consists of using combinations of joint movement known to maximize the movement of the peripheral nerves in relation to adjacent structures. The intervention will be delivered in one session only. | Other | Neural mobilization - sliding |
Primary outcome
Range of motion of the Straight Leg Raising test
Time frame: Baseline
The hip is raised to maximum flexion and the degree of flexion is measured with universal goniometer
Range of motion of the Straight Leg Raising test
Time frame: Approximately 45 minutes after baseline measurements
The hip is raised to maximum flexion and the degree of flexion is measured with universal goniometer
Range of motion of the Straight Leg Raising test
Time frame: At least 24 hours after baseline measurements
The hip is raised to maximum flexion and the degree of flexion is measured with universal goniometer
9 secondary outcomes
Heat threshold
Time frame: Baseline
Heat threshold
Time frame: Approximately 45 minutes after baseline measurements
Heat threshold
Time frame: At least 24 hours after baseline measurements
Cold threshold
Time frame: Baseline
Cold threshold
Time frame: Approximately 45 minutes after baseline measurements
Cold threshold
Time frame: At least 24 hours after baseline measurements
Pressure pain threshold
Time frame: Baseline
Pressure pain threshold
Time frame: Approximately 45 minutes after baseline measurements
Pressure pain threshold
Time frame: At least 24 hours after baseline measurements
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 5 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Healthy Individuals
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
Active, not recruitingObservational study
Evaluation of MTHFR and DNMT3B Gene Polymorphisms Along With Periodontal Clinical Parameters in Healthy Individuals and Individuals With Type 2 Diabetes and Periodontitis
Periodontitis, Type 2 Diabetes Mellitus (DM)
Not yet recruitingEarly Phase 1
Efficacy of the pA1c®HI Postbiotic in Metabolic Regulation in Healthy Individuals With Hyperglycemia
Hyperglycemias, Prediabetes
RecruitingObservational study
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Eczema, Atopic Dermatitis
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.
Anabela Silva, PhD principal investigator
University of aveiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neural mobilization - tension. and Neural mobilization - gliding in people with Healthy Individuals, run by Aveiro University at 1 site in Portugal.
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 1 inclusion and 1 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 5 Apr 2018. 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 Portugal. 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?
Range of motion of the Straight Leg Raising test (time frame: Baseline). 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 5 Apr 2018.