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Effects of Cervical Manipulation and Mobilization on Salivary Cortisol Concentrations

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ClinicalTrials.gov Identifier: NCT02628470
Recruitment Status : Completed
First Posted : December 11, 2015
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
Valera-Calero JA; Plaza-Manzano G; Gallego-Izquierdo T
Information provided by (Responsible Party):
Prof. Dr. Daniel Pecos Martín, University of Alcala

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


Condition or disease Intervention/treatment Phase
Neck Pain Procedure: cervical manipulation Procedure: cervical control exercises Procedure: Oscillatory mobilization technique Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Cervical Manipulation and Mobilization on Salivary Cortisol Concentrations
Actual Study Start Date : December 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017


Arm Intervention/treatment
Experimental: group cervical manipulation
The patient is supine without a pillow and physiotherapist standing in the ipsilateral corner of the hand of the thrust.
Procedure: cervical manipulation
cervical high-velocity low-amplitude thrust manipulation

Placebo Comparator: Placebo group
Participants will receive a protocol of domiciliary cervical control exercises.
Procedure: cervical control exercises
Exercises of flexion, extension and rotation of the cervical spine

Active Comparator: Group cervical mobilization
Oscillatory mobilization technique. With the patient in prone, the investigator applies an oscillatory motion in the most painful cervical segment for three minutes
Procedure: Oscillatory mobilization technique
Joint mobilization technique type III according Maitland




Primary Outcome Measures :
  1. salivary cortisol [ Time Frame: Change from baseline cortisol concentration at after the intervention(immediately after) ]

    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 :
  1. Neck Disability [ Time Frame: Change from baseline disability at one week after intervention ]
    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

  2. Neck pain [ Time Frame: Change from baseline neck pain at one week after intervention ]
    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

  3. Tenderness [ Time Frame: Change from baseline pain threshold pressure at after the intervention (immediately after) and one week after ]
    With a algometer we will assessed the tenderness upon facet joints C2-C3 and C5-C6

  4. Cervical joint Range [ Time Frame: Change from baseline mobility at immediately after at one week after intervention ]
    Flexion, inclination, extension and rotational movement ranges will be measured with a cervical goniometer



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02628470


Locations
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Spain
Alcalá Universuty
Alcalá de Henares, Madrid, Spain, 28806
Sponsors and Collaborators
University of Alcala
Valera-Calero JA; Plaza-Manzano G; Gallego-Izquierdo T
Investigators
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Study Director: Tomás Gallego-Izquierdo, Dr Alcalá University

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Responsible Party: Prof. Dr. Daniel Pecos Martín, Dr. Pecos-Martin, D, University of Alcala
ClinicalTrials.gov Identifier: NCT02628470     History of Changes
Other Study ID Numbers: CEI/HU/2015/10
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Daniel Pecos Martín, University of Alcala:
Cervical pain, cervicalgia
Additional relevant MeSH terms:
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Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Hydrocortisone
Anti-Inflammatory Agents