Effectiveness of an Eye-Cervical Re-education Program in Chronic Neck Pain

June 22, 2017 updated by: Veronica Perez Cabezas, University of Cadiz

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background:

In Physiotherapy there is a growing interest of authors to clarify the relationship between the visual system and the neck. Aspects such as deficiencies in eye movement during cervical rotation are common disorders in patients who have suffered whiplash trauma or have dizzy syndromes. On the other hand, deep muscle disorders of the neck are related to the decrease in cervical-ocular reflex. Furthermore, some disorders in eye movements in patients with idiopathic neck pain have been identified.

Consequently, a pragmatic approach to multimodal intervention has been recommended to address changes in sensorimotor control at the cervical level. For this purpose, head-neck sensitization exercises (joint position sense training with head relocation), oculo-motor exercises (ie, eye stability, eye-neck coordination) or balance training have been proposed. These programs lead to a sensorimotor control, reducing pain and disability in the neck. However, it is not known if this approach to treatment is a significant improvement when compared to the implementation of other physiotherapy procedures, so it is unknown if the application of training oculocervical proprioception is more advisable than other modalities of physiotherapy treatment for the improvement of CNP symptoms.

Material and method:

This research is an analytical, longitudinal, prospective, experimental, evaluator blinded study. It is controlled with two parallel groups, randomized clinical trial.

The sample consisted of patients recruited in a Physiotherapy consultation in Cadiz (Spain). These assessments were made before and after the start of program and to the end of intervention (8 months).

Patients were randomized to control or experimental group. All patients are given a Combined Physiotherapy Protocol, no apply an Eye-Cervical Re-education Program in subjects in the first group and performing an Eye-Cervical Re-education Program in the second. This program was carried out by the physiotherapist. Subjects received a total of ten sessions on alternate days.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Cadiz, Spain, 11009
        • Faculty of Nursing and Physiotherapy. University of Cadiz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inclusion criteria were: to show symptoms and clinical signs of neck pain, have a medical diagnosis, meet the following lines according to the classification proposed by the Working Group "Bone and Joint Decade 2000-2010" (Axis 1:Health problem receiving health care, Axis II: tertiary care; healthcare in a private Physiotherapy center, Axis III: Grades I and II, Axis IV: Long term, more than three months, Line V: isolated, periodic or permanent Crises) and cervical pain of a mechanical origin, due to repetitive motion or maintenance of positions for long periods.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
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
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).
Experimental: Experimental Group

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of pain
Time Frame: Baseline and end of treatment(4 weeks)
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
Time Frame: Baseline and end of treatment (4 weeks)
Measured with inclinometer
Baseline and end of treatment (4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Rating Index
Time Frame: Baseline and end of treatment(4 weeks)
McGill questionnaire in Spanish version
Baseline and end of treatment(4 weeks)
Numerical rating scale for pain
Time Frame: Baseline and end of treatment(4 weeks)
VAS visual analogue scale
Baseline and end of treatment(4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cadiz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

June 12, 2017

First Submitted That Met QC Criteria

June 22, 2017

First Posted (Actual)

June 23, 2017

Study Record Updates

Last Update Posted (Actual)

June 23, 2017

Last Update Submitted That Met QC Criteria

June 22, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U-Cadiz-V Perez-Cabezas

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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