NCT03218644

Brief Summary

Introduction: Neck pain is among the most common and costly for industrialized societies. It is difficult to know the exact structure causing the pain so most are considered as non-specific neck pain. There is a correlation between the alteration of craneocervical proprioception and neck pain. The evidence for treatment with proprioceptive exercises is very limited. Objective: To know the efficacy of a proprioceptive exercise program for neck pain and to compare its effects with a cervical mobility program. Materials and Methods: Subjects between 18-65 years old with non-traumatic neck pain are included. They will be randomized into two groups of exercises: proprioception or mobility, which will be developed over a period of two weeks, every day, with a total of 10 sessions per patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

July 14, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2017

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

1 month

First QC Date

July 8, 2017

Last Update Submit

July 21, 2020

Conditions

Keywords

Proprioception

Outcome Measures

Primary Outcomes (1)

  • Intensity of Pain

    Visual Analogue Scale (VAS) was used to register the pain. The VAS is a 10-point rating scale.

    four weeks

Secondary Outcomes (5)

  • Head Repositioning Test

    four weeks

  • Cervical movement range (CROM)

    four weeks

  • Pain points

    four weeks

  • Neck Disability

    four weeks

  • Health status

    four weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

Follow the usual treatment and perform the exercises of cervical mobility before a mirror.

Other: Mobility exercises

Experimental group

EXPERIMENTAL

The same procedure is followed by substituting proprioceptive exercises for craniocervical sensorimotor control with a laser instrument located on the patient's head and a target.

Other: Proprioception exercises

Interventions

Usual treatment and exercises of cervical mobility before a mirror.

Control group

proprioceptive exercises for craniocervical sensorimotor control.

Experimental group

Eligibility Criteria

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

You may qualify if:

  • Neck pain (NAD I-II) of recent onset (0-3 months)

You may not qualify if:

  • Cognitive difficulties
  • Lack of commitment to attend sessions
  • Subjects with pacemakers or defibrillators
  • Being receiving another physiotherapeutic treatment
  • Other pathologies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gemma Victoria Espí-López

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gemma Victoria Espí-López

    fisiotherapy

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 8, 2017

First Posted

July 14, 2017

Study Start

July 14, 2017

Primary Completion

August 15, 2017

Study Completion

August 15, 2017

Last Updated

July 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations