Neck PainNCT05078489
Acute Effects of Action Observation on Neck Pain
A study testing Action-observation therapy in people with Neck Pain, run by Aveiro University at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 months to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Action-observation therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 20 Nov 2021to 15 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Neurological disorder/deficits;
- Rheumatic autoimmune diseases;
- History of cancer;
- Severe cervical trauma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Action Observation on Pain Intensity, Muscle Strength, Tactile Acuity and Pressure Pain Threshold.
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.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- Action-observation therapy, Placebo
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action-observation therapyOther
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.
PlaceboOther
Participants will watch a natural landscape without any human.
| Study group | Role | What they receive |
|---|---|---|
| Action-observation arm | Experimental | Participants will be asked to watch videos of neck exercises without performing any exercise. The intervention will take approximately 15 minutes. Receives: Other: Action-observation therapy |
| Placebo intervention | Placebo comparator | Participants will be asked to watch videos of landscapes. The intervention will take approximately 15 minutes. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
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
Measured: Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
Secondary outcomes (10)
Pain intensity
Measured with a 100 mm Visual Analogue Scale
Measured: Baseline
Pain intensity
Measured with a 100 mm Visual Analogue Scale
Measured: Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
Tactile acuity
Assessed as the ability of the participant to distinguish two points using a caliper and the measurement units is millimetres.
Measured: Baseline
Tactile acuity
Assessed as the ability of the participant to distinguish two points using a caliper and the measurement units is millimetres.
Measured: Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
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.
Measured: Baseline
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.
Measured: Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
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.
Measured: Baseline
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.
Measured: Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
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.
Measured: Baseline
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.
Measured: Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start20 Nov 2021
- Primary completion30 Oct 2022
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anabela G Silva, Aveiro University
- Investigators
- Anabela o Silva, Principal investigator, School of Health Sciences, University of Aveiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078489
- Sponsor's protocol ID
- 21-CED/2020
- Status last verified
- Feb 2023
- First submitted
- 4 Oct 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Al Shrbaji T, Bou-Assaf M, Andias R, Silva AG. A single session of action observation therapy versus observing a natural landscape in adults with chronic neck pain - a randomized controlled trial. BMC Musculoskelet Disord. 2023 Dec 19;24(1):983. doi: 10.1186/s12891-023-07070-w.
PubMed 38114952
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Action Observation on Pain Intensity, Muscle Strength, Tactile Acuity and Pressure Pain Threshold.
- ClinicalTrials.gov ID
- NCT05078489
- Acronym / sponsor ID
- 21-CED/2020
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Action-observation arm | Experimental | Other: Action-observation therapyParticipants will be asked to watch videos of neck exercises without performing any exercise. The intervention will take approximately 15 minutes. |
| Placebo intervention | Placebo comparator | Other: PlaceboParticipants will be asked to watch videos of landscapes. The intervention will take approximately 15 minutes. |
Who may qualify
- Ages
- 18 months to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action-observation therapyAction 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. | Other | Action-observation arm |
| PlaceboParticipants will watch a natural landscape without any human. | Other | Placebo intervention |
Primary outcome
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
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
10 secondary outcomes
Pain intensity
Time frame: Baseline
Pain intensity
Time frame: Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
Tactile acuity
Time frame: Baseline
Tactile acuity
Time frame: Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
Neck flexors strength
Time frame: Baseline
Neck flexors strength
Time frame: Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
Neck extensors strength
Time frame: Baseline
Neck extensors strength
Time frame: Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
Neck lateral flexors strength
Time frame: Baseline
Neck lateral flexors strength
Time frame: Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Derived from this study: PubMed 38114952Al Shrbaji T, Bou-Assaf M, Andias R, Silva AG. A single session of action observation therapy versus observing a natural landscape in adults with chronic neck pain - a randomized controlled trial. BMC Musculoskelet Disord. 2023 Dec 19;24(1):983. doi: 10.1186/s12891-023-07070-w.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anabela o Silva principal investigator
School of Health Sciences, University of Aveiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action-observation therapy in people with Neck Pain, run by Aveiro University at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure pain thresholds (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05078489, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.