- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05078489
Acute Effects of Action Observation on Neck Pain
Acute Effects of Action Observation on Pain Intensity, Muscle Strength, Tactile Acuity and Pressure Pain Threshold.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a randomized controlled trial with two arms: action observation group vs control group. The action observation group will be asked to watch videos of neck exercises with full attention and concentration and not perform any motion or execute any movement during the observation time. The control group will be asked to watch videos of a landscape.
Participants will be assessed at baseline and at post-intervention for muscle strength, pain intensity, pressure pain threshold and tactile acuity.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anabela Silva, PhD
- Phone Number: 27120 +351 234247119
- Email: asilva@ua.pt
Study Locations
-
-
-
Aveiro, Portugal
- School of Health Sciences, University of Aveiro
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Have nonspecific chronic neck pain, defined as a recurrent or persistent pain that lasts more than 3 months, with no trauma or etiology/diagnosis associated.
Exclusion Criteria:
- Visual and hearing dysfunction not corrected by eyeglasses/contact lenses or a hearing aid;
- Infectious diseases;
- Cervical myelopathy;
- Cervical surgery;
- Cervical fracture or/and subluxation;
- Vestibular pathology;
- Neurological disorder/deficits;
- Rheumatic autoimmune diseases;
- History of cancer;
- Severe cervical trauma.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Action-observation arm
Participants will be asked to watch videos of neck exercises without performing any exercise.
The intervention will take approximately 15 minutes.
|
Action observation therapy involves the observation and perception of human movement performed by others.
The observation of actions performed by others activates in the perceiver the same neural structures responsible for the actual execution of those same actions.
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Placebo Comparator: Placebo intervention
Participants will be asked to watch videos of landscapes.
The intervention will take approximately 15 minutes.
|
Participants will watch a natural landscape without any human.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pressure pain thresholds
Time Frame: Baseline
|
Pressure pain thresholds are the minimum amount of pressure applied with an algometer that is perceived as being painful; is measured in Kgf
|
Baseline
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Pressure pain thresholds
Time Frame: Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
|
Pressure pain thresholds are the minimum amount of pressure applied with an algometer that is perceived as being painful; is measured in Kgf
|
Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: Baseline
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Measured with a 100 mm Visual Analogue Scale
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Baseline
|
Pain intensity
Time Frame: Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
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Measured with a 100 mm Visual Analogue Scale
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Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
|
Tactile acuity
Time Frame: Baseline
|
Assessed as the ability of the participant to distinguish two points using a caliper and the measurement units is millimetres.
|
Baseline
|
Tactile acuity
Time Frame: Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
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Assessed as the ability of the participant to distinguish two points using a caliper and the measurement units is millimetres.
|
Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
|
Neck flexors strength
Time Frame: Baseline
|
A dynamometer will be used against the forehead of the participants to quantify the isometric strength and units of measurement will be Newtons.
|
Baseline
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Neck flexors strength
Time Frame: Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
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A dynamometer will be used against the forehead of the participants to quantify the isometric strength and units of measurement will be Newtons.
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Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
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Neck extensors strength
Time Frame: Baseline
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A dynamometer will be used against the posterior part of the head of the participants to quantify the isometric strength and units of measurement will be Newtons.
|
Baseline
|
Neck extensors strength
Time Frame: Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
|
A dynamometer will be used against the posterior part of the head of the participants to quantify the isometric strength and units of measurement will be Newtons.
|
Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
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Neck lateral flexors strength
Time Frame: Baseline
|
A dynamometer will be used against the lateral aspect of the head of the participants to quantify the isometric strength and units of measurement will be Newtons.
|
Baseline
|
Neck lateral flexors strength
Time Frame: Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
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A dynamometer will be used against the lateral aspect of the head of the participants to quantify the isometric strength and units of measurement will be Newtons.
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Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Catastrophizing
Time Frame: Baseline
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Measured with the Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
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Baseline
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Disability
Time Frame: Baseline
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Measured using the Neck Disability Index (Range: 0 - 50 and higher values indicate higher disability)
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Baseline
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Fear of movement
Time Frame: Baseline
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Measured with the TAMPA Scale of Kinesiophobia (range: 13-52 and higher values are indicative of higher levels of fear of movement)
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Baseline
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Fear-avoidance beliefs
Time Frame: Baseline
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Measured with the Fear-Avoidance Beliefs Questionnaire (range: 0-66 with higher scores indicating higher fear-avoidance beliefs)
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Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
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
- 21-CED/2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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