NCT05078489

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

November 20, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

October 4, 2021

Last Update Submit

February 17, 2023

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (10)

  • Pain intensity

    Baseline

  • Pain intensity

    Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).

  • Tactile acuity

    Baseline

  • Tactile acuity

    Post-intervention (within the same session of the baseline assessment but approximately 30 minutes after that).

  • Neck flexors strength

    Baseline

  • +5 more secondary outcomes

Other Outcomes (4)

  • Catastrophizing

    Baseline

  • Disability

    Baseline

  • Fear of movement

    Baseline

  • +1 more other outcomes

Study Arms (2)

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.

Other: Action-observation therapy

Placebo intervention

PLACEBO COMPARATOR

Participants will be asked to watch videos of landscapes. The intervention will take approximately 15 minutes.

Other: Placebo

Interventions

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.

Action-observation arm
PlaceboOTHER

Participants will watch a natural landscape without any human.

Placebo intervention

Eligibility Criteria

Age18 Months - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Health Sciences, University of Aveiro

Aveiro, Portugal

Location

Related Publications (1)

  • 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.

    PMID: 38114952DERIVED

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anabela o Silva

    School of Health Sciences, University of Aveiro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 4, 2021

First Posted

October 14, 2021

Study Start

November 20, 2021

Primary Completion

October 30, 2022

Study Completion

February 15, 2023

Last Updated

February 21, 2023

Record last verified: 2023-02

Locations

PT(1)