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Effects of Cervical Manipulation and Mobilization on Salivary Cortisol Concentrations

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
cervical manipulation
cervical control exercises
Oscillatory mobilization technique
Sponsored by
University of Alcala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Cervical pain, cervicalgia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Manifest mechanical pain in the neck to the T1 vertebra as lower limit
  • Present the medical diagnosis of mechanical neck pain
  • Do not be getting any kind of hormonal therapy (including oral contraceptives)
  • Be over 18 years old

Exclusion Criteria:

  • Subjects that are associated with the adrenal gland pathology
  • Pathologies excess or defect of cortisol
  • Pathology severe psychological disorders related to anxiety, mood or stress
  • Participants pregnant due to changes in hormonal determinations
  • Contraindication to manipulation or mobilization

Sites / Locations

  • Alcalá Universuty

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

group cervical manipulation

Placebo group

Group cervical mobilization

Arm Description

The patient is supine without a pillow and physiotherapist standing in the ipsilateral corner of the hand of the thrust.

Participants will receive a protocol of domiciliary cervical control exercises.

Oscillatory mobilization technique. With the patient in prone, the investigator applies an oscillatory motion in the most painful cervical segment for three minutes

Outcomes

Primary Outcome Measures

salivary cortisol
For measuring salivary cortisol a Cortisol kit RE52611 ELISA® will be provided by the IBL laboratory. The saliva samples will be stored at -20 ° C until analysis, being coded by the researcher and measured by a blinded assessor. For this, it will be added 50 uL sample of saliva in the tubes of the kit with a pipette. Subsequently 100 uL of enzyme conjugate will be added to each tube, covering the plate with adhesive and shaking carefully. It will be incubated 2 hours at room temperature (18-25 ° C) in a centrifuge at 400-600 rpm. After removing the adhesive and remove excess of solution wil be added 100 uL of TMB solution. It wil be centrifuged for 30 min under the same conditions. At the end, they wil be added 100 uL of TMB solution inhibitory. The results wil be measured with a photometer at 450 nm within 15 minutes of adding the last reagent.

Secondary Outcome Measures

Neck Disability
This test is a questionnaire of 10 questions to fill in the patient and disability measured by neck pain. It has been shown to have high reliability "test-retest" and be valid when compared with other measures of pain and disability
Neck pain
Using a visual analogue scale (VAS) of 10 cm consisting of an opaque unnumbered rule by the front and numbered from 0 to 10 in the back side with an expression of no pain at 0 cm and maximum pain at 10 cm
Tenderness
With a algometer we will assessed the tenderness upon facet joints C2-C3 and C5-C6
Cervical joint Range
Flexion, inclination, extension and rotational movement ranges will be measured with a cervical goniometer

Full Information

First Posted
November 30, 2015
Last Updated
April 24, 2017
Sponsor
University of Alcala
Collaborators
Valera-Calero JA; Plaza-Manzano G; Gallego-Izquierdo T
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1. Study Identification

Unique Protocol Identification Number
NCT02628470
Brief Title
Effects of Cervical Manipulation and Mobilization on Salivary Cortisol Concentrations
Official Title
Effects of Cervical Manipulation and Mobilization on Salivary Cortisol Concentrations
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala
Collaborators
Valera-Calero JA; Plaza-Manzano G; Gallego-Izquierdo T

4. Oversight

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

5. Study Description

Brief Summary
Currently, there are many studies about the effects of manual therapy on pain, but there are not enough studies to know what are the mechanisms that cause these effects. Although there is a research measuring neuromodulators substances after a cervical and dorsal manipulation, it has been done in healthy subjects and there is no information about mobilization. This work aims to select a sample with chronic neck pain, incorporating the cervical mobilization as a therapeutic approach to compare the effects of both techniques because not all patients accept the manipulation as a treatment technique (mobilization is much better tolerated) and to verify that the liberation of cortisol is not just caused by the stress on the joint manipulation and the psychological stress and expectation may be important. The hypothesis of this paper is that cervical manipulation and mobilization in subjects with chronic neck pain there will increase salivary cortisol levels. It is also expected a little increase in the expectation of being manipulated group because of the psychological stress. It is expected an improvement in the neck disability, pain and range of motion in the intervention groups immediately after and in the three groups the following week after the exercise. The main objective of the study is to measure and analyze changes in salivary cortisol concentrations after the intervention in the three groups. Secondary objectives is to analyze the changes in range of motion and disability caused by neck pain neck pain level
Detailed Description
STUDY DESIGN: Experimental study using a randomized controlled trial with blinded evaluator with three parallel groups, two experimental and one placebo. INTERVENTION Experimental group cervical manipulation: The patient is supine without a pillow and physiotherapist standing in the ipsilateral corner of the hand of the thrust. If the segment to manipulate is the upper cervical spine, the radial aspect of the distal phalanx of the index finger of the pulse is placed on the posterolateral aspect of the transverse process of the atlas (In medium or low segments of cervical spine on the vertebra on which we want to make the thrust). The thumb rests on the zygomatic arch and the other fingers rest on the back of the skull, leaving the forearm perpendicular to the neck. In middle or lower cervical spine, the thumb rests on the angle of the jaw and the other fingers on the back of the neck. The contralateral hand rests against the contralateral side of the patient's skull with the fingers facing caudally, so we left ear between the index and middle fingers. To take the patient to the end of range of motion will be added ipsilateral inclination and contralateral rotation without exceeding the 30-40 °. There will be a contralateral displacement of the head and a posteroanterior glide to take the patient to energizing. The impulse is made in pure contralateral rotation. Experimental Group of cervical posterior-anterior mobilization in the most painful segment: Maitland described by the patient is prone with his forehead in the palms. The thumb rests on the articular pillar (on the transverse blade) and the other fingers around the neck to stabilize the soft tissue. The limit pressure will be that cause pain to the patient. The oscillatory motion is produced by the arms and the body while the hands remain stable with a pressure distributed uniformly around the patient's neck. It is important that the neck and hands move as a unit. high-amplitude technique may be performed by raising the patient's neck with the pads of the fingers This technique was performed for 3 minutes remaining below the pain threshold of the patient. Placebo group: The subjects of this group will expect a cervical manipulation to check the psychological component has an effect on cortisol segregation. It will proceed with the same protocol as in the group of cervical manipulation, but without joint stress or thrust. Participants will receive a protocol of domiciliary cervical control exercises adapted to each subject for deep cervical muscles after taking the second salivary sample. Seasonal timing will be considered (evaluating the subjects in the same month), circadian rhythms (evaluating subjects mid-morning to avoid peak morning cortisol) and periods of the menstrual cycle as they are factors that can determine the results. In the case of the menstrual cycle they are cited the seventh day of the cycle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Cervical pain, cervicalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group cervical manipulation
Arm Type
Experimental
Arm Description
The patient is supine without a pillow and physiotherapist standing in the ipsilateral corner of the hand of the thrust.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Participants will receive a protocol of domiciliary cervical control exercises.
Arm Title
Group cervical mobilization
Arm Type
Active Comparator
Arm Description
Oscillatory mobilization technique. With the patient in prone, the investigator applies an oscillatory motion in the most painful cervical segment for three minutes
Intervention Type
Procedure
Intervention Name(s)
cervical manipulation
Intervention Description
cervical high-velocity low-amplitude thrust manipulation
Intervention Type
Procedure
Intervention Name(s)
cervical control exercises
Intervention Description
Exercises of flexion, extension and rotation of the cervical spine
Intervention Type
Procedure
Intervention Name(s)
Oscillatory mobilization technique
Intervention Description
Joint mobilization technique type III according Maitland
Primary Outcome Measure Information:
Title
salivary cortisol
Description
For measuring salivary cortisol a Cortisol kit RE52611 ELISA® will be provided by the IBL laboratory. The saliva samples will be stored at -20 ° C until analysis, being coded by the researcher and measured by a blinded assessor. For this, it will be added 50 uL sample of saliva in the tubes of the kit with a pipette. Subsequently 100 uL of enzyme conjugate will be added to each tube, covering the plate with adhesive and shaking carefully. It will be incubated 2 hours at room temperature (18-25 ° C) in a centrifuge at 400-600 rpm. After removing the adhesive and remove excess of solution wil be added 100 uL of TMB solution. It wil be centrifuged for 30 min under the same conditions. At the end, they wil be added 100 uL of TMB solution inhibitory. The results wil be measured with a photometer at 450 nm within 15 minutes of adding the last reagent.
Time Frame
Change from baseline cortisol concentration at after the intervention(immediately after)
Secondary Outcome Measure Information:
Title
Neck Disability
Description
This test is a questionnaire of 10 questions to fill in the patient and disability measured by neck pain. It has been shown to have high reliability "test-retest" and be valid when compared with other measures of pain and disability
Time Frame
Change from baseline disability at one week after intervention
Title
Neck pain
Description
Using a visual analogue scale (VAS) of 10 cm consisting of an opaque unnumbered rule by the front and numbered from 0 to 10 in the back side with an expression of no pain at 0 cm and maximum pain at 10 cm
Time Frame
Change from baseline neck pain at one week after intervention
Title
Tenderness
Description
With a algometer we will assessed the tenderness upon facet joints C2-C3 and C5-C6
Time Frame
Change from baseline pain threshold pressure at after the intervention (immediately after) and one week after
Title
Cervical joint Range
Description
Flexion, inclination, extension and rotational movement ranges will be measured with a cervical goniometer
Time Frame
Change from baseline mobility at immediately after at one week after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Manifest mechanical pain in the neck to the T1 vertebra as lower limit Present the medical diagnosis of mechanical neck pain Do not be getting any kind of hormonal therapy (including oral contraceptives) Be over 18 years old Exclusion Criteria: Subjects that are associated with the adrenal gland pathology Pathologies excess or defect of cortisol Pathology severe psychological disorders related to anxiety, mood or stress Participants pregnant due to changes in hormonal determinations Contraindication to manipulation or mobilization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomás Gallego-Izquierdo, Dr
Organizational Affiliation
Alcalá University
Official's Role
Study Director
Facility Information:
Facility Name
Alcalá Universuty
City
Alcalá de Henares
State/Province
Madrid
ZIP/Postal Code
28806
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effects of Cervical Manipulation and Mobilization on Salivary Cortisol Concentrations

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