NCT03197285

Brief Summary

The aim of the present study is to value the effectiveness of an Eye-Cervical Re-education Program (ECRP) to decrease pain and increase mobility in the cervical area compared to a Combined Physiotherapy Protocol (CPP) in patients with chronic neck pain symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 23, 2017

Completed
Last Updated

June 23, 2017

Status Verified

June 1, 2017

Enrollment Period

1.4 years

First QC Date

June 12, 2017

Last Update Submit

June 22, 2017

Conditions

Keywords

neck paineyepropioceptionrange of motionpain

Outcome Measures

Primary Outcomes (2)

  • Change of pain

    Algometer in 6 points (two trapezius, two in angular of the scapula and two sub-occipital)

    Baseline and end of treatment(4 weeks)

  • Change of range of motion

    Measured with inclinometer

    Baseline and end of treatment (4 weeks)

Secondary Outcomes (2)

  • Pain Rating Index

    Baseline and end of treatment(4 weeks)

  • Numerical rating scale for pain

    Baseline and end of treatment(4 weeks)

Study Arms (2)

Control Group

ACTIVE COMPARATOR

All patients are given a Combined Physiotherapy Protocol (CPP) consisting of: Thermotherapy (70 w continuous microwave for 10 minutes), therapeutic massage (surface rubbing for 5 minutes, 10 minutes of compression and kneading massage and 2 minutes of final surface friction), application of analgesic currents (TENS, by self-adhesive silicone electrodes 4x4 cm, symmetrical biphasic rectangular current, 200 µs width pulse, a frequency of 1 Hz for 10 minutes. The patient should notice a slight vibration, without it being painful).

Other: Combined Physiotherapy Protocol

Experimental Group

EXPERIMENTAL

All patients are given a Combined Physiotherapy Protocol (CPP) consisting of: Thermotherapy (70 w continuous microwave for 10 minutes), therapeutic massage (surface rubbing for 5 minutes, 10 minutes of compression and kneading massage and 2 minutes of final surface friction), application of analgesic currents (TENS, by self-adhesive silicone electrodes 4x4 cm, symmetrical biphasic rectangular current, 200 µs width pulse, a frequency of 1 Hz for 10 minutes. The patient should notice a slight vibration, without it being painful). The ECRP developed by Revel et al.(Revel et al., 1994) was also applied to patients in the experimental group. EYE-CERVICAL RE-EDUCATION PROGRAM (ECRP) This includes a total of 10 exercises that has proprioceptive reprogramming in the cervical area

Other: EYE-CERVICAL RE-EDUCATION PROGRAM

Interventions

Subjects received a total of ten sessions on alternate days. This includes a total of 10 exercises that has proprioceptive reprogramming in the cervical area with the following phases: 1. To stimulate ocular mobility without including the cervical movement. The patient was placed in the supine position and the physiotherapist seated, at the height of the head. 2. To exercise cervical mobility with restricted eye movement. The patient is placed on a rotating stool. The ocular mobility is excluded with opaque glasses that allowed exclusively the foveal vision 3. Finally we stimulate eye and neck movement coordination. The patient continued to sit on the stool, this time without the glasses.

Experimental Group

Thermotherapy (70 w continuous microwave for 10 minutes), therapeutic massage (surface rubbing for 5 minutes, 10 minutes of compression and kneading massage and 2 minutes of final surface friction), application of analgesic currents (TENS, by self-adhesive silicone electrodes 4x4 cm, symmetrical biphasic rectangular current, 200 µs width pulse, a frequency of 1 Hz for 10 minutes. The patient should notice a slight vibration, without it being painful).

Control Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • Dizziness syndrome, microwave contraindications and analgesic currents (therapeutic procedures used), post-traumatic, rheumatologic, neurological, infectious or tumor cervical pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing and Physiotherapy. University of Cadiz

Cadiz, 11009, Spain

Location

Related Publications (5)

  • Andersen LL, Hansen K, Mortensen OS, Zebis MK. Prevalence and anatomical location of muscle tenderness in adults with nonspecific neck/shoulder pain. BMC Musculoskelet Disord. 2011 Jul 22;12:169. doi: 10.1186/1471-2474-12-169.

    PMID: 21777478BACKGROUND
  • Treleaven J, Jull G, LowChoy N. Smooth pursuit neck torsion test in whiplash-associated disorders: relationship to self-reports of neck pain and disability, dizziness and anxiety. J Rehabil Med. 2005 Jul;37(4):219-23. doi: 10.1080/16501970410024299.

    PMID: 16024477BACKGROUND
  • Revel M, Minguet M, Gregoy P, Vaillant J, Manuel JL. Changes in cervicocephalic kinesthesia after a proprioceptive rehabilitation program in patients with neck pain: a randomized controlled study. Arch Phys Med Rehabil. 1994 Aug;75(8):895-9. doi: 10.1016/0003-9993(94)90115-5.

    PMID: 8053797BACKGROUND
  • Treleaven J, Takasaki H. Characteristics of visual disturbances reported by subjects with neck pain. Man Ther. 2014 Jun;19(3):203-7. doi: 10.1016/j.math.2014.01.005. Epub 2014 Jan 27.

    PMID: 24521926BACKGROUND
  • Perez-Cabezas V, Ruiz-Molinero C, Jimenez-Rejano JJ, Chamorro-Moriana G, Gonzalez-Medina G, Chillon-Martinez R. Effectiveness of an Eye-Cervical Re-Education Program in Chronic Neck Pain: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2020 Feb 26;2020:2760413. doi: 10.1155/2020/2760413. eCollection 2020.

MeSH Terms

Conditions

Neck PainAsthenopiaPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsEye Diseases

Study Design

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

Study Record Dates

First Submitted

June 12, 2017

First Posted

June 23, 2017

Study Start

June 1, 2012

Primary Completion

November 1, 2013

Study Completion

May 1, 2016

Last Updated

June 23, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations