- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01161758
Study on the Effect of Cervical Mobilization on Motor Function and Pressure Pain Threshold in Pain Free Individuals
July 13, 2010 updated by: Curtin University
A Crossover Study on the Effect of Cervical Mobilization on Motor Function and Pressure Pain Threshold in Pain Free Individuals
Passive accessory cervical mobilization is widely used as a clinical approach to the management of musculoskeletal pain of spinal origin.
The purpose of the study is to determine if passive cervical mobilization can improve motor function in situations where motor performance is not impaired by the presence of pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Cervical mobilization has been shown to elicit effects on pain perception, autonomic function and motor function in subjects who experience musculoskeletal pain.
The improvement in motor function may be a direct effect of the treatment or secondary to a hypoalgesic effect.
This study aims to demonstrate whether it is possible to alter motor function following joint mobilization, in situations where motor performance is not impaired by pain.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- No history of neck or back pain over the last six months
- Without any previous experience with spinal manual therapy techniques
Exclusion Criteria:
- History of musculoskeletal or rheumatologic conditions
- Any kind of spinal surgery
- Dizziness
- Previous trauma to the cervical spine
- Neurological signs or symptoms
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Passive cervical mobilisation
Grade III cervical mobilization technique as described by Maitland.
Applied to left C5/6 Segment.
|
Passive cervical mobilization which involved an oscillatory grade III unilateral postero-anterior mobilization applied to the left C5/C6 segment.
The mobilization consisted of 3 periods of 1 minute applications with a resting period of 1 minute in between.
Other Names:
|
|
Placebo Comparator: Manual contact
Manual contact control, which involved light manual contact on the left C5/C6 segment as if to perform the treatment technique.
|
Manual contact control, which involved light manual contact on the left C5/C6 segment as if to perform the treatment technique.
The light manual contact consisted of 3 periods of 1 minute applications with a resting period of 1 minute in between.
Other Names:
|
|
No Intervention: Non-contact control
Non-contact control, which involved the subject resting in the treatment position without any physical contact between the researcher and the subject.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Electromyography of sternocleidomastoid muscle.
Time Frame: Pre intervention (baseline) and 1 minute post intervention
|
Measurement of sternocleidomastoid muscle activation during deep neck flexion.
The degree of neck flexion is determined by a pressure biofeedback unit place underneath the neck.
EMG of the left and right sternocleidomastoids are recorded for 5seconds at each level of neck flexion
|
Pre intervention (baseline) and 1 minute post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure pain threshold
Time Frame: Pre intervention (baseline) and 1 minute post intervention
|
The algometer to measure pressure pain threshold was applied at a constant rate of 40 kPa/sec on the posterior aspect of the left and right articular pillar of C5/C6.
|
Pre intervention (baseline) and 1 minute post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Benjamin Soon Tze Chin, MManipTher, The University of Queensland
- Principal Investigator: Annina Schmid, MManipTher, The University of Queensland
- Principal Investigator: Elias Fridriksson, MManipTher, Curtin University
- Principal Investigator: Philip Cheong, MManipTher, Curtin University
- Principal Investigator: Elisabeth Gresslos, MManipTher, Curitn University of Technology
- Study Chair: Anthony Wright, PhD, Curtin University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Primary Completion (Actual)
October 1, 2005
Study Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
July 8, 2010
First Submitted That Met QC Criteria
July 13, 2010
First Posted (Estimate)
July 14, 2010
Study Record Updates
Last Update Posted (Estimate)
July 14, 2010
Last Update Submitted That Met QC Criteria
July 13, 2010
Last Verified
November 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PT0004
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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