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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05078489
Other study ID # 21-CED/2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 20, 2021
Est. completion date February 15, 2023

Study information

Verified date February 2023
Source Aveiro University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 15, 2023
Est. primary completion date October 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Months to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Action-observation therapy
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.
Placebo
Participants will watch a natural landscape without any human.

Locations

Country Name City State
Portugal School of Health Sciences, University of Aveiro Aveiro

Sponsors (1)

Lead Sponsor Collaborator
Aveiro University

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Other Catastrophizing Measured with the Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing) Baseline
Other Disability Measured using the Neck Disability Index (Range: 0 - 50 and higher values indicate higher disability) Baseline
Other Fear of movement Measured with the TAMPA Scale of Kinesiophobia (range: 13-52 and higher values are indicative of higher levels of fear of movement) Baseline
Other Fear-avoidance beliefs Measured with the Fear-Avoidance Beliefs Questionnaire (range: 0-66 with higher scores indicating higher fear-avoidance beliefs) Baseline
Primary 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 Baseline
Primary 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 Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
Secondary Pain intensity Measured with a 100 mm Visual Analogue Scale Baseline
Secondary Pain intensity Measured with a 100 mm Visual Analogue Scale Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
Secondary Tactile acuity Assessed as the ability of the participant to distinguish two points using a caliper and the measurement units is millimetres. Baseline
Secondary Tactile acuity 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).
Secondary 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. Baseline
Secondary 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. Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
Secondary 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. Baseline
Secondary 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. Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
Secondary 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. Baseline
Secondary 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. Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
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