- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05733429
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
Not yet recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
120
Phase
- 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
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age will range from 18 to 70 years
- Patients of both sexes.
- Neck pain diagnosed by physician greater than 3 months in duration.
- 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:
- Dizziness syndrome.
- Post-traumatic as whiplash
- Neurological, infectious, or tumor cervical pain.
- Pregnant women.
- Patients having speech and understanding problems.
- Past history of neck surgery
- Dizziness syndrome.
- Post-traumatic as whiplash.
- Neurological, infectious, or tumor cervical pain.
- Pregnant women.
- Patients having speech and understanding problems.
- 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 |
Intervention / Treatment |
|---|---|
|
Experimental: eye cervical re-education
patients will receive eye cervical re-education three times a week for four weeks
|
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
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
|
the patients will receive conventional physical therapy programs in the form of hot packs, therapeutic massage, cervical isometric strengthening exercises, and scapular stabilization exercises.
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
|
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
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
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
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)
March 2, 2023
Primary Completion (Anticipated)
October 30, 2023
Study Completion (Anticipated)
October 30, 2023
Study Registration Dates
First Submitted
February 8, 2023
First Submitted That Met QC Criteria
February 8, 2023
First Posted (Actual)
February 17, 2023
Study Record Updates
Last Update Posted (Actual)
February 17, 2023
Last Update Submitted That Met QC Criteria
February 8, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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