- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02782585
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Neck pain
Exclusion Criteria:
- myelopathy
- fracture
- infection
- dystonia
- tumor
- inflammatory disease
- fibromyalgia
- or osteoporosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group 1
Cervical Manipulation
|
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.
|
Experimental: Experimental group 2
Cervical lateral glide
|
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.
|
Placebo Comparator: Control group
Cervical Mobilisation
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Pressure Pain Thresholds (PPT) at 24 hours
Time Frame: 24 hours, 5 minutes after the treatment
|
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
Time Frame: 24 hours, 5 minutes after the treatment
|
Will be used to measure anxiety status
|
24 hours, 5 minutes after the treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beck depression Inventory (BDI-II)
Time Frame: 24 hours, 5 minutes after the treatment
|
Will be used to measure depression status
|
24 hours, 5 minutes after the treatment
|
Tampa Scale for Kinesiophobia
Time Frame: 24 hours, 5 minutes after the treatment
|
Will be used to measure Kinesiophobia status
|
24 hours, 5 minutes after the treatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: JORGE H VILLAFAÑE, PhD, Don Gnocchi Foundation
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Psychological interaction
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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