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

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: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Other: Active neck mobilization; Other: Active Mobilization of the sciatic nerve

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: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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".	Change from baseline in Visual Analog Scale at 2 minutes after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Before intervention and 2 minutes after
Mechanical pressure Algometer	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	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	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	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

• Sponsor: Universidad Miguel Hernandez de Elche
• Investigators: 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

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 30, 2018

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: July 25, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): December 3, 2018
• Last Update Submitted That Met QC Criteria: November 30, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Neck pain; Sciatic nerve; Myofascial trigger point; Neural mobilization
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID 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