The Effect of Lower Limbs Neural Mobilization in Subjects With Cervical Pain.

November 30, 2018 updated by: Roser Bel-lan Roldan, Universidad Miguel Hernandez de Elche

Analysing the Immediate Effects of Sciatic Nerve Mobilization on the Range of Cervical Mobility and on the Myofascial Trigger Points of the Cervical Muscles. Pilot Study.

No studies have investigated the effects of a Sciatic nerve mobilization in subjects with neck pain. This study aims to determine the immediate effects of a lower limbs neural mobilization on cervical range of motion and on the perception of pain in the most common trigger points located in the cervical musculature.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A convenience sample will be used to obtain subjects The subjects will be recruited through posted advertisements on social networks. The inclusion and exclusion criteria will be applied to the volunteers. The sample wil comprise university students and administrative workers with neck pain. The subjects will be screened by a screening questionnaire and all of them, they will be required to sign an inform consent before participating to the study. After signing it, they will be randomly divide into control group subject to a placebo technique and the intervention group subject to an active mobilization of the sciatic nerve.

To assess changes in cervical articular range, will be used, a cervical goniometer (CROM) and for changes in pressure pain threshold of the trigger points will be used a mechanical algometer. Furthermore, to asses changes in pain perception will be used a visual numerical scale. The statistical analysis will be performed using the statistical program SPSS 25.0, comparing the results between both groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alicante
      • San Juan De Alicante, Alicante, Spain, 03550
        • Miguel Hernández University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • To spend more than 3 hours at the computer.
  • To have or have had neck pain during the last 3 weeks.

Exclusion Criteria:

  • To have had traumatisms, traffic accidents and surgeries in the last 2 months.
  • To have taken any analgesic tablets before the treatment.
  • To be in a physiotherapy treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Active neck mobilization
The subjects, who were randomly allocated to group active neurodynamic mobilization group, will receive the active sciatic nerve mobilization intervention. The subject will be instructed to do a a modification of the slump. The procedure will be performed 1 minute with each leg, two times, the subjects will rest one minute between each mobilization and between series.
Other: Active neck mobilization
The subjects, receive an active neck mobilization intervention.
Experimental: Active Mobilization of the Sciatic nerve
The subjects, who were randomly allocated to group active neurodynamic mobilization group, will receive the active sciatic nerve mobilization intervention. The subject will be instructed to do a a modification of the slump. The procedure will be performed 1 minute with each leg, two times, the subjects will rest one minute between each mobilization and between series.
Other: Active Mobilization of the sciatic nerve
The subjects, receive an active sciatic nerve mobilization intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain level at rest
Time Frame: Change from baseline in Visual Analog Scale at 2 minutes after intervention
A Visual Analog Scale, will be used for recording level of pain at rest. The VAS evaluates levels of pain intensity using an 10-point scale (range 0-10), with 0 being classified as "no sensation" and 10 "pain as bad as could be".
Change from baseline in Visual Analog Scale at 2 minutes after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cervical Range of Motion (CROM)
Time Frame: Before intervention and 2 minutes after
The Cervical Range of Motion (CROM) device will be used to measure the cervical range of motion, including flexion, extension, lateral flexion and rotation.
Before intervention and 2 minutes after
Mechanical pressure Algometer
Time Frame: Before intervention and 2 minutes after
The Mechanical pressure Algometer will be used to measure changes in pain threshold of sensitive points located in the cervical musculature.
Before intervention and 2 minutes after
Vernier caliper
Time Frame: Before intervention and 2 minutes after
The Vernier caliper will be used to measure the active opening of the mouth.
Before intervention and 2 minutes after
The Neck Disability Index, Spanish version
Time Frame: Before intervention

The Neck Disability Index questionnaire is a reliable instrument to assess functional disability in neck pain patients. Will be used to assess the subjects' perceived disability level and how their neck pain affect to their daily live.

Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. All the points can be summed to a total score. The test can be interpretated as a raw score, with a maximum score of 50, or as a percentage.

0 points or 0% means : no activity limitations , 50 points or 100% means complete activity limitation.
Before intervention
Hours of daily use of display screens
Time Frame: Before intervention
The subjects will be asked at the beginning of the study about how many hours they spend using display screens daily.
Before intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Miguel Hernandez de Elche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sergio Hernández-Sánchez, PhD-PT, Universidad Miguel Hernandez de Elche
  • Study Director: Carlos Lozano-Quijada, PhD-PT, Universidad Miguel Hernandez de Elche
  • Principal Investigator: Roser Bel-lan, PT, Universidad Miguel Hernandez de Elche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DPC.EPP.02.18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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