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

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Active neck mobilization
Active Mobilization of the sciatic nerve
Sponsored by
Universidad Miguel Hernandez de Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Neck pain, Neural mobilization, Myofascial trigger point, Sciatic nerve

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Miguel Hernandez University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Active neck mobilization

Active Mobilization of the Sciatic nerve

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain level at rest
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".

Secondary Outcome Measures

Cervical Range of Motion (CROM)
The Cervical Range of Motion (CROM) device will be used to measure the cervical range of motion, including flexion, extension, lateral flexion and rotation.
Mechanical pressure Algometer
The Mechanical pressure Algometer will be used to measure changes in pain threshold of sensitive points located in the cervical musculature.
Vernier caliper
The Vernier caliper will be used to measure the active opening of the mouth.
The Neck Disability Index, Spanish version
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.
Hours of daily use of display screens
The subjects will be asked at the beginning of the study about how many hours they spend using display screens daily.

Full Information

First Posted
July 12, 2018
Last Updated
November 30, 2018
Sponsor
Universidad Miguel Hernandez de Elche
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1. Study Identification

Unique Protocol Identification Number
NCT03603054
Brief Title
The Effect of Lower Limbs Neural Mobilization in Subjects With Cervical Pain.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Miguel Hernandez de Elche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Neck pain, Neural mobilization, Myofascial trigger point, Sciatic nerve

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study sample will be randomly divide into 2 groups, a control group subject to a placebo technique and an intervention group subject to an active mobilization of the sciatic nerve.
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active neck mobilization
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Active Mobilization of the Sciatic nerve
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Active neck mobilization
Intervention Description
The subjects, receive an active neck mobilization intervention.
Intervention Type
Other
Intervention Name(s)
Active Mobilization of the sciatic nerve
Intervention Description
The subjects, receive an active sciatic nerve mobilization intervention.
Primary Outcome Measure Information:
Title
Pain level at rest
Description
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".
Time Frame
Change from baseline in Visual Analog Scale at 2 minutes after intervention
Secondary Outcome Measure Information:
Title
Cervical Range of Motion (CROM)
Description
The Cervical Range of Motion (CROM) device will be used to measure the cervical range of motion, including flexion, extension, lateral flexion and rotation.
Time Frame
Before intervention and 2 minutes after
Title
Mechanical pressure Algometer
Description
The Mechanical pressure Algometer will be used to measure changes in pain threshold of sensitive points located in the cervical musculature.
Time Frame
Before intervention and 2 minutes after
Title
Vernier caliper
Description
The Vernier caliper will be used to measure the active opening of the mouth.
Time Frame
Before intervention and 2 minutes after
Title
The Neck Disability Index, Spanish version
Description
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.
Time Frame
Before intervention
Title
Hours of daily use of display screens
Description
The subjects will be asked at the beginning of the study about how many hours they spend using display screens daily.
Time Frame
Before intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio Hernández-Sánchez, PhD-PT
Organizational Affiliation
Universidad Miguel Hernandez de Elche
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Carlos Lozano-Quijada, PhD-PT
Organizational Affiliation
Universidad Miguel Hernandez de Elche
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Roser Bel-lan, PT
Organizational Affiliation
Universidad Miguel Hernandez de Elche
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miguel Hernandez University
City
San Juan De Alicante
State/Province
Alicante
ZIP/Postal Code
03550
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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