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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03197285
Other study ID # U-Cadiz-V Perez-Cabezas
Secondary ID
Status Completed
Phase N/A
First received June 12, 2017
Last updated June 22, 2017
Start date June 2012
Est. completion date May 2016

Study information

Verified date June 2017
Source University of Cadiz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date May 2016
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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).

Locations

Country Name City State
Spain Faculty of Nursing and Physiotherapy. University of Cadiz Cadiz

Sponsors (1)

Lead Sponsor Collaborator
University of Cadiz

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary Change of range of motion Measured with inclinometer Baseline and end of treatment (4 weeks)
Secondary Pain Rating Index McGill questionnaire in Spanish version Baseline and end of treatment(4 weeks)
Secondary Numerical rating scale for pain VAS visual analogue scale Baseline and end of treatment(4 weeks)
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