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Manual Therapy Techniques on Cervical Spine and Psychological Interaction

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cervical manipulation
Cervical lateral glide
Cervical mobilisation
Sponsored by
Fondazione Don Carlo Gnocchi Onlus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring neck pain, Manual therapy, psychological interaction

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Neck pain

Exclusion Criteria:

  • myelopathy
  • fracture
  • infection
  • dystonia
  • tumor
  • inflammatory disease
  • fibromyalgia
  • or osteoporosis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Experimental group 1

    Experimental group 2

    Control group

    Arm Description

    Cervical Manipulation

    Cervical lateral glide

    Cervical Mobilisation

    Outcomes

    Primary Outcome Measures

    Change from Pressure Pain Thresholds (PPT) at 24 hours
    PPT will be assessed bilaterally over the C7 zygapophyseal joint, epicondyle region, and trapezious muscle by an assessor blinded to the subjects condition.
    Change from State-Trait Anxiety Inventory subscale (STAI-E) at 24 hours
    Will be used to measure anxiety status

    Secondary Outcome Measures

    Beck depression Inventory (BDI-II)
    Will be used to measure depression status
    Tampa Scale for Kinesiophobia
    Will be used to measure Kinesiophobia status

    Full Information

    First Posted
    May 17, 2016
    Last Updated
    May 20, 2016
    Sponsor
    Fondazione Don Carlo Gnocchi Onlus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02782585
    Brief Title
    Manual Therapy Techniques on Cervical Spine and Psychological Interaction
    Official Title
    Hypoalgesic Effects of Three Different Manual Therapy Techniques on Cervical Spine and Psychological Interaction: Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2010 (undefined)
    Primary Completion Date
    October 2010 (Actual)
    Study Completion Date
    June 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fondazione Don Carlo Gnocchi Onlus

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Manual therapy (MT) techniques applied over cervical region have over both local (neck) and distant regions (elbow) in both asymptomatic and symptomatic populations. Neurophysiological mechanisms are hypothesized to explain the underlying effects, with effects originating from peripheral mechanisms, spinal cord and supraspinal mechanisms. There is also an increasing interest in the study of the role of psychological variables in the treatment success in neck pain. Psychological variables, like anxiety catastrophizing or kinesiophobia are related to poor prognosis in the development of pain outcomes and disability in neck pain, being the Fear-Avoidance Model of pain one of the most tested models in this field.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neck Pain
    Keywords
    neck pain, Manual therapy, psychological interaction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    75 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group 1
    Arm Type
    Experimental
    Arm Description
    Cervical Manipulation
    Arm Title
    Experimental group 2
    Arm Type
    Experimental
    Arm Description
    Cervical lateral glide
    Arm Title
    Control group
    Arm Type
    Placebo Comparator
    Arm Description
    Cervical Mobilisation
    Intervention Type
    Other
    Intervention Name(s)
    Cervical manipulation
    Intervention Description
    The therapist cradled the subject´s head with the other hand. Gentle ipsilateral side flexion and contralateral rotation to the targeted side were introduced until slight tension was perceived in the tissues at the contact point. The High velocity, low amplitude (HVLA) manipulation was directed upward and medially in the direction of the subject´s contralateral eye. The therapist monitored for cavitation or 'popping sound' accompanying the manipulations. If an audible popping sound was not heard during the first manipulative attempt, the procedure was repeated in the second time.
    Intervention Type
    Other
    Intervention Name(s)
    Cervical lateral glide
    Intervention Description
    The upper limb of the right side of subjects was maintained in rest, with the arm along the trunk and the hand over the abdominal wall. The right hand of the treating therapist was positioned over scapula region, to depress the scapula while left hand cradled the occiput and neck above C5-C6 and left hand produced a passive lateral movement of the occipital and neck region.
    Intervention Type
    Other
    Intervention Name(s)
    Cervical mobilisation
    Intervention Description
    The patients received a passive cervical mobilization that involved a grade III oscillatory unilateral posteroanterior mobilization to the right articular pillar of C5/C6 segment as described Maitland at a frequency of 2Hz. All the subjects were positioned in prone position as the protocol described by Sterling et al. for 3 sets of 2 minutes with 1 minute rest between sets.
    Primary Outcome Measure Information:
    Title
    Change from Pressure Pain Thresholds (PPT) at 24 hours
    Description
    PPT will be assessed bilaterally over the C7 zygapophyseal joint, epicondyle region, and trapezious muscle by an assessor blinded to the subjects condition.
    Time Frame
    24 hours, 5 minutes after the treatment
    Title
    Change from State-Trait Anxiety Inventory subscale (STAI-E) at 24 hours
    Description
    Will be used to measure anxiety status
    Time Frame
    24 hours, 5 minutes after the treatment
    Secondary Outcome Measure Information:
    Title
    Beck depression Inventory (BDI-II)
    Description
    Will be used to measure depression status
    Time Frame
    24 hours, 5 minutes after the treatment
    Title
    Tampa Scale for Kinesiophobia
    Description
    Will be used to measure Kinesiophobia status
    Time Frame
    24 hours, 5 minutes after the treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Neck pain Exclusion Criteria: myelopathy fracture infection dystonia tumor inflammatory disease fibromyalgia or osteoporosis
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    JORGE H VILLAFAÑE, PhD
    Organizational Affiliation
    Don Gnocchi Foundation
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29037630
    Citation
    Alonso-Perez JL, Lopez-Lopez A, La Touche R, Lerma-Lara S, Suarez E, Rojas J, Bishop MD, Villafane JH, Fernandez-Carnero J. Hypoalgesic effects of three different manual therapy techniques on cervical spine and psychological interaction: A randomized clinical trial. J Bodyw Mov Ther. 2017 Oct;21(4):798-803. doi: 10.1016/j.jbmt.2016.12.005. Epub 2016 Dec 22.
    Results Reference
    derived

    Learn more about this trial

    Manual Therapy Techniques on Cervical Spine and Psychological Interaction

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