- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03029260
Effects of Nervous System Mobilization
Effect of Nervous System Mobilization on Heat, Cold and Mechanical Pain Thresholds and Lower Limb Flexibility
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aveiro, Portugal, 3810-193
- School of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- naïve to nervous system mobilization;
Exclusion Criteria:
- Any surgery or trauma in the previous 6 months; neurological, cardiorespiratory or rheumatic pathology; cancer.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 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. |
Active Comparator: Neural mobilization - sliding
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline
|
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
|
Approximately 45 minutes after baseline measurements
|
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
|
At least 24 hours after baseline measurements
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heat threshold
Time Frame: Baseline
|
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.
|
Baseline
|
Heat threshold
Time Frame: Approximately 45 minutes after baseline measurements
|
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.
|
Approximately 45 minutes after baseline measurements
|
Heat threshold
Time Frame: At least 24 hours after baseline measurements
|
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.
|
At least 24 hours after baseline measurements
|
Cold threshold
Time Frame: Baseline
|
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.
|
Baseline
|
Cold threshold
Time Frame: Approximately 45 minutes after baseline measurements
|
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.
|
Approximately 45 minutes after baseline measurements
|
Cold threshold
Time Frame: At least 24 hours after baseline measurements
|
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.
|
At least 24 hours after baseline measurements
|
Pressure pain threshold
Time Frame: Baseline
|
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.
|
Baseline
|
Pressure pain threshold
Time Frame: Approximately 45 minutes after baseline measurements
|
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.
|
Approximately 45 minutes after baseline measurements
|
Pressure pain threshold
Time Frame: At least 24 hours after baseline measurements
|
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.
|
At least 24 hours after baseline measurements
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anabela Silva, PhD, University of Aveiro
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NSM01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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