Back to resultsAcute Effects of Action Observation on Neck Pain
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Action-observation therapy
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain
Eligibility Criteria
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.
Sites / Locations
- School of Health Sciences, University of Aveiro
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Action-observation arm
Placebo intervention
Arm Description
Participants will be asked to watch videos of neck exercises without performing any exercise. The intervention will take approximately 15 minutes.
Participants will be asked to watch videos of landscapes. The intervention will take approximately 15 minutes.
Outcomes
Primary Outcome Measures
Pressure pain thresholds
Pressure pain thresholds are the minimum amount of pressure applied with an algometer that is perceived as being painful; is measured in Kgf
Pressure pain thresholds
Pressure pain thresholds are the minimum amount of pressure applied with an algometer that is perceived as being painful; is measured in Kgf
Secondary Outcome Measures
Pain intensity
Measured with a 100 mm Visual Analogue Scale
Pain intensity
Measured with a 100 mm Visual Analogue Scale
Tactile acuity
Assessed as the ability of the participant to distinguish two points using a caliper and the measurement units is millimetres.
Tactile acuity
Assessed as the ability of the participant to distinguish two points using a caliper and the measurement units is millimetres.
Neck flexors strength
A dynamometer will be used against the forehead of the participants to quantify the isometric strength and units of measurement will be Newtons.
Neck flexors strength
A dynamometer will be used against the forehead of the participants to quantify the isometric strength and units of measurement will be Newtons.
Neck extensors strength
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.
Neck extensors strength
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.
Neck lateral flexors strength
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.
Neck lateral flexors strength
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05078489
Brief Title
Acute Effects of Action Observation on Neck Pain
Official Title
Acute Effects of Action Observation on Pain Intensity, Muscle Strength, Tactile Acuity and Pressure Pain Threshold.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 20, 2021 (Actual)
Primary Completion Date
October 30, 2022 (Actual)
Study Completion Date
February 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aveiro University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to assess the immediate effects of action observation therapy on the cervical muscles' strength, pain intensity, tactile acuity and pain pressure threshold in individuals with chronic nonspecific neck pain.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Action-observation arm
Arm Type
Experimental
Arm Description
Participants will be asked to watch videos of neck exercises without performing any exercise. The intervention will take approximately 15 minutes.
Arm Title
Placebo intervention
Arm Type
Placebo Comparator
Arm Description
Participants will be asked to watch videos of landscapes. The intervention will take approximately 15 minutes.
Intervention Type
Other
Intervention Name(s)
Action-observation therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Participants will watch a natural landscape without any human.
Primary Outcome Measure Information:
Title
Pressure pain thresholds
Description
Pressure pain thresholds are the minimum amount of pressure applied with an algometer that is perceived as being painful; is measured in Kgf
Time Frame
Baseline
Title
Pressure pain thresholds
Description
Pressure pain thresholds are the minimum amount of pressure applied with an algometer that is perceived as being painful; is measured in Kgf
Time Frame
Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
Secondary Outcome Measure Information:
Title
Pain intensity
Description
Measured with a 100 mm Visual Analogue Scale
Time Frame
Baseline
Title
Pain intensity
Description
Measured with a 100 mm Visual Analogue Scale
Time Frame
Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
Title
Tactile acuity
Description
Assessed as the ability of the participant to distinguish two points using a caliper and the measurement units is millimetres.
Time Frame
Baseline
Title
Tactile acuity
Description
Assessed as the ability of the participant to distinguish two points using a caliper and the measurement units is millimetres.
Time Frame
Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
Title
Neck flexors strength
Description
A dynamometer will be used against the forehead of the participants to quantify the isometric strength and units of measurement will be Newtons.
Time Frame
Baseline
Title
Neck flexors strength
Description
A dynamometer will be used against the forehead of the participants to quantify the isometric strength and units of measurement will be Newtons.
Time Frame
Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
Title
Neck extensors strength
Description
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.
Time Frame
Baseline
Title
Neck extensors strength
Description
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.
Time Frame
Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
Title
Neck lateral flexors strength
Description
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.
Time Frame
Baseline
Title
Neck lateral flexors strength
Description
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.
Time Frame
Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
Other Pre-specified Outcome Measures:
Title
Catastrophizing
Description
Measured with the Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
Time Frame
Baseline
Title
Disability
Description
Measured using the Neck Disability Index (Range: 0 - 50 and higher values indicate higher disability)
Time Frame
Baseline
Title
Fear of movement
Description
Measured with the TAMPA Scale of Kinesiophobia (range: 13-52 and higher values are indicative of higher levels of fear of movement)
Time Frame
Baseline
Title
Fear-avoidance beliefs
Description
Measured with the Fear-Avoidance Beliefs Questionnaire (range: 0-66 with higher scores indicating higher fear-avoidance beliefs)
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anabela o Silva
Organizational Affiliation
School of Health Sciences, University of Aveiro
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Health Sciences, University of Aveiro
City
Aveiro
Country
Portugal
12. IPD Sharing Statement
Learn more about this trial
Acute Effects of Action Observation on Neck Pain
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