NCT02553759

Brief Summary

The aim of the present protocol is to prove if the observed actions (AOb) will improve the cervical range of motion (CROM) in patients with non-specific chronic neck pain (CNP). This study is a parallel-group double blind randomized clinical. Outcome measures were CROM, and pressure pain detection thresholds (PPDT) with a digital algometer. The follow-up will consist of three evaluations: pre- treatment, post-treatment and 10 minutes after second measurement (motor imagery).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Oct 2013

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
Last Updated

September 18, 2015

Status Verified

September 1, 2015

Enrollment Period

8 months

First QC Date

September 16, 2015

Last Update Submit

September 17, 2015

Conditions

Keywords

observed actionrange of motionmirror neuron

Outcome Measures

Primary Outcomes (1)

  • Range of motion degrees

    10 minutes

Study Arms (2)

Effective movement

EXPERIMENTAL

This group will see a 1-minute video showing an individual performing a cervical rotation movement to each side, first 10 times towards the right and then 10 times towards the left. The movement will be performed effectively over the entire course of the cervical path, approximately 80º

Other: Actions observed

Ineffective movement

ACTIVE COMPARATOR

This group will see a 1-minute video showing an individual performing a cervical rotation movement ineffectively, without achieving the maximum cervical travel, performing approximately 40º. First, 10 movements towards the right will be performed and then 10 towards the left

Other: Actions observed

Interventions

Patients observed movements without realize them. After this actions, movements will be imagined by patients

Effective movementIneffective movement

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Non specific chronic neck pain
  • Diagnosed by medical specialist

You may not qualify if:

  • cervical osteoarthritis or polyarthrosis
  • rheumatic disease
  • history of cervical hernia
  • whiplash syndrome
  • surgery on the neck, face or shoulders,
  • systemic disease, medical history of cancer
  • significant trauma that the patient relates to their pain and/or refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alfonso Gil-Martínez, Master

    Hospital Universitario La Paz

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiothreapist. Master in Science

Study Record Dates

First Submitted

September 16, 2015

First Posted

September 18, 2015

Study Start

October 1, 2013

Primary Completion

June 1, 2014

Study Completion

May 1, 2015

Last Updated

September 18, 2015

Record last verified: 2015-09