Manual Therapy Techniques on Cervical Spine and Psychological Interaction
Hypoalgesic Effects of Three Different Manual Therapy Techniques on Cervical Spine and Psychological Interaction: Randomized Clinical Trial
1 other identifier
interventional
75
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2010
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 17, 2016
CompletedFirst Posted
Study publicly available on registry
May 25, 2016
CompletedMay 25, 2016
May 1, 2016
3 months
May 17, 2016
May 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
24 hours, 5 minutes after the treatment
Change from State-Trait Anxiety Inventory subscale (STAI-E) at 24 hours
Will be used to measure anxiety status
24 hours, 5 minutes after the treatment
Secondary Outcomes (2)
Beck depression Inventory (BDI-II)
24 hours, 5 minutes after the treatment
Tampa Scale for Kinesiophobia
24 hours, 5 minutes after the treatment
Study Arms (3)
Experimental group 1
EXPERIMENTALCervical Manipulation
Experimental group 2
EXPERIMENTALCervical lateral glide
Control group
PLACEBO COMPARATORCervical Mobilisation
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Neck pain
You may not qualify if:
- myelopathy
- fracture
- infection
- dystonia
- tumor
- inflammatory disease
- fibromyalgia
- or osteoporosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 29037630DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
JORGE H VILLAFAÑE, PhD
Don Gnocchi Foundation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher
Study Record Dates
First Submitted
May 17, 2016
First Posted
May 25, 2016
Study Start
July 1, 2010
Primary Completion
October 1, 2010
Study Completion
June 1, 2011
Last Updated
May 25, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share