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

Sponsor

University of Cadiz (Other)

Overall Status

Completed

CT.gov ID

NCT03197285

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neck Pain Eye Strain	Other: EYE-CERVICAL RE-EDUCATION PROGRAM Other: Combined Physiotherapy Protocol	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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.

Actual Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

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: 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. 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 Finally we stimulate eye and neck movement coordination. The patient continued to sit on the stool, this time without the glasses.

Arm

Intervention/Treatment

Active Comparator: Control Group

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: 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. 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 Finally we stimulate eye and neck movement coordination. The patient continued to sit on the stool, this time without the glasses.

Outcome Measures

Primary Outcome Measures

Change of pain [Baseline and end of treatment(4 weeks)]
Algometer in 6 points (two trapezius, two in angular of the scapula and two sub-occipital)
Change of range of motion [Baseline and end of treatment (4 weeks)]
Measured with inclinometer

Secondary Outcome Measures

Pain Rating Index [Baseline and end of treatment(4 weeks)]
McGill questionnaire in Spanish version
Numerical rating scale for pain [Baseline and end of treatment(4 weeks)]
VAS visual analogue scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.