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
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring neck pain, Manual therapy, psychological interaction
Eligibility Criteria
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
NCT ID
NCT02782585
First Posted
May 17, 2016
Last Updated
May 20, 2016
Sponsor
Fondazione Don Carlo Gnocchi Onlus
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
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Manual Therapy Techniques on Cervical Spine and Psychological Interaction
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