NCT03547752

Brief Summary

The observation of actions and motor imagery has demonstrated the activation of certain mechanisms similar to those that occur during active movement, which could induce immediate changes in the amplitudes of movement and sensorimotor variables in observed and imagined movements. The main aim of the study was test the immediate effect of a protocol of observed actions and motor imagery on cervical range of motion and pain intensity in patients with non-specific chronic neck pain (NSCNP). Randomized double-blind clinical trial in patients with DCCI at a primary health care center in the Community of Madrid. A random distribution of study subjects was made into two groups: a) cervical motion videos were presented at full range of motion and b) the videos presented showed a range of motion limited to 40%. In both groups, visualization tasks of actions were alternated with internal kinesthetic motor imagery, in periods of 1min in 2 consecutive series and with a total of 12 minutes of intervention. Cervical range of motion was assessed with a cervical goniometer and pain intensity immediately following the intervention with an Analog Visual Scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

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

Study Start

First participant enrolled

March 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 1, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

1.2 years

First QC Date

May 1, 2018

Last Update Submit

June 4, 2018

Conditions

Keywords

motor imaginerymental training

Outcome Measures

Primary Outcomes (1)

  • Change in Cervical Range of Movement

    CROM goniometer

    at the beginning and after the intervention, until the end of the study (24 hours)

Secondary Outcomes (5)

  • Cervical Pain Disability

    at the beginning and end of the intervention, until the end of the study (24 hours)

  • Pain Intensity

    at the beginning and end of the intervention, until the end of the study (24 hours)

  • Catastrophizism

    at the beginning and end of the intervention, until the end of the study (24 hours)

  • Health Related Quality of Life

    at the beginning and end of the intervention, until the end of the study (24 hours)

  • Anxiety and Depression

    at the beginning and end of the intervention, until the end of the study (24 hours)

Study Arms (2)

Effective movement group

ACTIVE COMPARATOR

Observation of a video of neck movement at 100% range of movement, and imagination of the same observed movement, feeling the realization of the movement but not developing it.

Other: observed action and motor imaginery

Ineffective movement group

EXPERIMENTAL

Observation of a video of neck movement at 40% range of movement, and imagination of the same observed movement, feeling the realization of the movement but not developing it.

Other: observed action and motor imaginery

Interventions

Observation of a video of neck movement and imagination of the same observed movement, feeling the realization of the movement but not developing it.

Effective movement groupIneffective movement group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nos-Specific Chronic Neck Pain lasting more than 3 months

You may not qualify if:

  • Systemic Disease diagnosed (i.e. Lupus, Fibrolyalgia or Rheumatoid Arthritis)
  • Background of fractures or surgery in the cervical region
  • congenital anomalies known
  • infectious processes or diagnosis of active cancer at the time of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CS Entrevías

Madrid, 28053, Spain

Location

Related Publications (5)

  • van Hecke O, Torrance N, Smith BH. Chronic pain epidemiology and its clinical relevance. Br J Anaesth. 2013 Jul;111(1):13-8. doi: 10.1093/bja/aet123.

    PMID: 23794640BACKGROUND
  • Munoz-Garcia D, Gil-Martinez A, Lopez-Lopez A, Lopez-de-Uralde-Villanueva I, La Touche R, Fernandez-Carnero J. Chronic Neck Pain and Cervico-Craniofacial Pain Patients Express Similar Levels of Neck Pain-Related Disability, Pain Catastrophizing, and Cervical Range of Motion. Pain Res Treat. 2016;2016:7296032. doi: 10.1155/2016/7296032. Epub 2016 Mar 29.

    PMID: 27119020BACKGROUND
  • Niddam DM, Lee SH, Su YT, Chan RC. Brain structural changes in patients with chronic myofascial pain. Eur J Pain. 2017 Jan;21(1):148-158. doi: 10.1002/ejp.911. Epub 2016 Jun 28.

    PMID: 27352085BACKGROUND
  • Mao C, Wei L, Zhang Q, Liao X, Yang X, Zhang M. Differences in brain structure in patients with distinct sites of chronic pain: A voxel-based morphometric analysis. Neural Regen Res. 2013 Nov 15;8(32):2981-90. doi: 10.3969/j.issn.1673-5374.2013.32.001.

    PMID: 25206618BACKGROUND
  • Eaves DL, Riach M, Holmes PS, Wright DJ. Motor Imagery during Action Observation: A Brief Review of Evidence, Theory and Future Research Opportunities. Front Neurosci. 2016 Nov 21;10:514. doi: 10.3389/fnins.2016.00514. eCollection 2016.

    PMID: 27917103BACKGROUND

MeSH Terms

Conditions

Neck PainChronic PainMusculoskeletal Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 1, 2018

First Posted

June 6, 2018

Study Start

March 1, 2017

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

June 6, 2018

Record last verified: 2018-06

Locations