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

Primary Purpose

Neck Pain, Eye Strain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
EYE-CERVICAL RE-EDUCATION PROGRAM
Combined Physiotherapy Protocol
Sponsored by
University of Cadiz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring neck pain, eye, propioception, range of motion, pain

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Faculty of Nursing and Physiotherapy. University of Cadiz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Experimental Group

Arm Description

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).

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

Outcomes

Primary Outcome Measures

Change of pain
Algometer in 6 points (two trapezius, two in angular of the scapula and two sub-occipital)
Change of range of motion
Measured with inclinometer

Secondary Outcome Measures

Pain Rating Index
McGill questionnaire in Spanish version
Numerical rating scale for pain
VAS visual analogue scale

Full Information

First Posted
June 12, 2017
Last Updated
June 22, 2017
Sponsor
University of Cadiz
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1. Study Identification

Unique Protocol Identification Number
NCT03197285
Brief Title
Effectiveness of an Eye-Cervical Re-education Program in Chronic Neck Pain
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 2012 (Actual)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cadiz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Eye Strain
Keywords
neck pain, eye, propioception, range of motion, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
EYE-CERVICAL RE-EDUCATION PROGRAM
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Combined Physiotherapy Protocol
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change of pain
Description
Algometer in 6 points (two trapezius, two in angular of the scapula and two sub-occipital)
Time Frame
Baseline and end of treatment(4 weeks)
Title
Change of range of motion
Description
Measured with inclinometer
Time Frame
Baseline and end of treatment (4 weeks)
Secondary Outcome Measure Information:
Title
Pain Rating Index
Description
McGill questionnaire in Spanish version
Time Frame
Baseline and end of treatment(4 weeks)
Title
Numerical rating scale for pain
Description
VAS visual analogue scale
Time Frame
Baseline and end of treatment(4 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Nursing and Physiotherapy. University of Cadiz
City
Cadiz
ZIP/Postal Code
11009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21777478
Citation
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.
Results Reference
background
PubMed Identifier
16024477
Citation
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.
Results Reference
background
PubMed Identifier
8053797
Citation
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.
Results Reference
background
PubMed Identifier
24521926
Citation
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.
Results Reference
background
PubMed Identifier
32184889
Citation
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.
Results Reference
derived

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

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