Neck PainMNPNCT05733429
Eye-Cervical Re-education Versus Motor Imagery Therapy on Proprioception in Chronic Mechanical Neck Pain
A study testing eye cervical re-education, motor imagery therapy and conventional physical therapy in people with Neck Pain, run by Cairo University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- eye cervical re-education, motor imagery therapy and conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2023to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- eye cervical re-education, motor imagery therapy, conventional physical therapy
- Keywords
- Eye-Cervical Re-education, Motor Imagery Therapy, neck pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eye cervical re-educationOther
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
motor imagery therapyOther
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.
conventional physical therapyOther
the patients will receive conventional physical therapy programs in the form of hot packs, therapeutic massage, cervical isometric strengthening exercises, and scapular stabilization exercises.
| Study group | Role | What they receive |
|---|---|---|
| eye cervical re-education | Experimental | patients will receive eye cervical re-education three times a week for four weeks Receives: Other: eye cervical re-education; Other: conventional physical therapy |
| motor imagery therapy | Experimental | patients will receive motor imagery therapy three times a week for four weeks Receives: Other: motor imagery therapy; Other: conventional physical therapy |
| conventional physical therapy | Active comparator | patients will receive conventional physical therapy three times a week for four weeks Receives: Other: conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
joint position error
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).
Measured: up to four weeks
Secondary outcomes (4)
disability
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
Measured: up to four weeks
pain intensity
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
Measured: up to four weeks
rounded shoulder
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
Measured: up to four weeks
pressure pain threshold
pressure algometer device will be used for measuring pressure pain threshold
Measured: up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start2 Mar 2023 (estimated)
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- eye cervical re-education and motor imagery therapy
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabil Mahmoud Ismail Abdel-Aal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733429
- Sponsor's protocol ID
- P.T.REC/012/004164
- Acronym
- MNP
- Status last verified
- Feb 2023
- First submitted
- 8 Feb 2023
- Last updated
- 17 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eye-Cervical Re-education Versus Motor Imagery Therapy on Pain, Function, and Proprioception in Chronic Mechanical Neck Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05733429
- Acronym / sponsor ID
- MNP / P.T.REC/012/004164
- Conditions
- Neck Pain
- Keywords
- Eye-Cervical Re-education, Motor Imagery Therapy, neck pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Mar 2023 (estimated)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- eye cervical re-education and motor imagery therapy
| Arm | Type | Receives |
|---|---|---|
| eye cervical re-education | Experimental | Other: eye cervical re-education, Other: conventional physical therapypatients will receive eye cervical re-education three times a week for four weeks |
| motor imagery therapy | Experimental | Other: motor imagery therapy, Other: conventional physical therapypatients will receive motor imagery therapy three times a week for four weeks |
| conventional physical therapy | Active comparator | Other: conventional physical therapypatients will receive conventional physical therapy three times a week for four weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- Dizziness syndrome.
- Post-traumatic as whiplash
- Neurological, infectious, or tumor cervical pain.
- Pregnant women.
- Patients having speech and understanding problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eye cervical re-educationpatients 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 | eye cervical re-education |
| motor imagery therapythe 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. | Other | motor imagery therapy |
| conventional physical therapythe patients will receive conventional physical therapy programs in the form of hot packs, therapeutic massage, cervical isometric strengthening exercises, and scapular stabilization exercises. | Other | conventional physical therapy, eye cervical re-education, motor imagery therapy |
Primary outcome
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).
4 secondary outcomes
disability
Time frame: up to four weeks
pain intensity
Time frame: up to four weeks
rounded shoulder
Time frame: up to four weeks
pressure pain threshold
Time frame: up to four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing eye cervical re-education, motor imagery therapy and conventional physical therapy in people with Neck Pain, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact al shaymaa sh abd el azeim, lecturer (01033771553, alshaymaa.shaaban@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
joint position error (time frame: up to four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.