Eye-Cervical Re-education Versus Motor Imagery Therapy on Proprioception in Chronic Mechanical Neck Pain (MNP)

February 8, 2023 updated by: Nabil Mahmoud Ismail Abdel-Aal, Cairo University

Eye-Cervical Re-education Versus Motor Imagery Therapy on Pain, Function, and Proprioception in Chronic Mechanical Neck Pain: A Randomized Controlled Trial

this study will be conducted to investigate the effect of eye-cervical re-education versus motor imagery therapy on pain intensity level, pain pressure threshold, neck disability, cervical proprioception, and scapular protraction in patients with chronic mechanical neck pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Chronic neck pain is a common problem in modern and industrialized countries and among employed individuals. Pain is classified as chronic neck pain persists for more than 3 month, it may be felt all the time or worsen with certain activities. The cervical spine has an important role in providing the proprioceptive input and this is reflected in the abundance of cervical mechanoreceptors and their central and reflex connections to the vestibular, visual, and central nervous systems. Eye-cervical re-education program (ECRP) refer to a therapeutic procedure for correcting posture cephalic level in patients with cervical pain by improving eye-neck proprioception that reduced symptoms experienced by patients and improvement of the quality of cervical afferent input into the central nervous system. Motor imagery is the mental realization of motion without any motion occurs. It has two categories: kinesthetics and visual imagery. Kinaesthetic imagery is the situation of feeling a motion. Visual imagery has two types: internal visual and external visual. In the internal visual imagery, the motion is visualized within the body by seeing feet and arms. The external visual imagery is that one sees himself/herself from outside. one hundred and twenty patients will be allocated randomly into three groups; group A will receive eye cervical re-education and conventional therapy, group B will receive motor imagery therapy and conventional therapy and group C will receive conventional therapy only three times a week for four weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age will range from 18 to 70 years
  2. Patients of both sexes.
  3. Neck pain diagnosed by physician greater than 3 months in duration.
  4. Active or latent myofascial trigger points (MTrPs) in at least one of the following muscles: upper trapezius, levator scapulae, or splenius capitis. Both active and latent MTrPs were considered because latent MTrPs have been associated with the development of sensory motor dysfunction and may contribute to different chronic musculoskeletal pain disorders

Exclusion Criteria:

  1. Dizziness syndrome.
  2. Post-traumatic as whiplash
  3. Neurological, infectious, or tumor cervical pain.
  4. Pregnant women.
  5. Patients having speech and understanding problems.
  6. Past history of neck surgery
  7. Dizziness syndrome.
  8. Post-traumatic as whiplash.
  9. Neurological, infectious, or tumor cervical pain.
  10. Pregnant women.
  11. Patients having speech and understanding problems.
  12. Past history of neck surgery .

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: eye cervical re-education
patients will receive eye cervical re-education three times a week for four weeks
Other: eye cervical re-education
patients will receive eye-cervical re-education in the form of 10 exercises at three phases; the first phase will include stimulation of ocular mobility, the second phase will consist of Cervical mobility exercise with restricted eye movement and the third phase will include stimulation of eye and neck movement co-ordination
Other: conventional physical therapy
the patients will receive conventional physical therapy programs in the form of hot packs, therapeutic massage, cervical isometric strengthening exercises, and scapular stabilization exercises.
Experimental: motor imagery therapy
patients will receive motor imagery therapy three times a week for four weeks
Other: conventional physical therapy
the patients will receive conventional physical therapy programs in the form of hot packs, therapeutic massage, cervical isometric strengthening exercises, and scapular stabilization exercises.
Other: motor imagery therapy
the patients will receive motor imagery therapy for four weeks; the first week will receive kinesthetic imagery, the second week will receive visual imagery, the third week will receive action observation exercises with motor imagery and the fourth week will receive motor control exercises in front of a mirror.
Active Comparator: conventional physical therapy
patients will receive conventional physical therapy three times a week for four weeks
Other: conventional physical therapy
the patients will receive conventional physical therapy programs in the form of hot packs, therapeutic massage, cervical isometric strengthening exercises, and scapular stabilization exercises.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
joint position error
Time Frame: up to four weeks
The Cervical Joint Position Error (JPE) Test is a measurement tool used to clinically assess an individual's cervicocephalic proprioception ability. Cervicocephalic proprioception describes one's sense of position of their head and neck in space. The Cervical JPE Test measures the ability of a blindfolded patient to accurately relocate their head position back to a predetermined neutral point after cervical joint movement. The test is most commonly performed with head movement in the transverse and sagittal planes by cervical range of motion device (CROM).
up to four weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
disability
Time Frame: up to four weeks
The neck disability index (NDI) will be used for measuring neck disability and it is a self-patient-completed questionnaire that measures patients' functional status. It contains 10 questions regarding pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Each question has six answer choices scored from 0 to 5 as 0 indicates no disability and 5 indicates complete disability. All sections are scored then totaled on a scale from 0 to 50, as zero is the best possible score and 50 is the worst one
up to four weeks
pain intensity
Time Frame: up to four weeks
Visual Analogue Scale which is a 100-mm horizontal line will be used for measuring pain intensity. The patients will be instructed to represent their pain intensity level by marking anywhere on the line with "no pain" on the left side and "worst pain" on the right side
up to four weeks
rounded shoulder
Time Frame: up to four weeks
tape measurement will be used to to assess rounded shoulder: Subjects will be requested to stand normally with their hands hanging beside their bodies to test for rounded shoulder posture. Then, sternal notch, coracoid process, posteriolateral angle of the acromion process and the adjacent thoracic spinous process will be palpated and marked. The distance between sternal notch and coracoid process, and the distance between the posterolateral angle of the acromion process and the adjacent thoracic spinous process will measured by using tape
up to four weeks
pressure pain threshold
Time Frame: up to four weeks
pressure algometer device will be used for measuring pressure pain threshold
up to four weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P.T.REC/012/004164

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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