Cervical RadiculopathyNCT06732037
Effect of Kinetic Control Training on Flexion Relaxation Phenomenon and Craniovertebral Angle in Cervical Radiculopathy Patients
A study testing Conventional physical therapy program in people with Cervical Radiculopathy, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study is to determine the effect of kinetic control training on flexion relaxation phenomenon and craniovertebral angle in patients with cervical radiculopathy. Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Conventional physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2024to 22 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients will be referred from neurologist with the diagnosis cervical spondylosis.
- Patients will be included if they have unilateral radiculopathy due to spondylotic changes of the lower cervical spine (C5-C6 and C6-C7).
- Duration of symptoms is more than three months to avoid acute stage of inflammation.
- Patient's age ranged from 40 to 55 years.
- Patients from both sexes.
- Body mass index of all patients is ranged from 25-30 kg/m2.
- Patients will be screened prior to inclusion by measuring the craniovertebral angle, if the angle was less than 50, then a participant will be referred to the study
Who cannot join
- Spinal canal stenosis.
- Rheumatoid arthritis.
- Vertebrobasilar insufficiency.
- Spinal instability due to structural cause e.g., spondylolisthesis.
- Systemic disease (cardiovascular, infectious and/or metabolic disease that could interrupt exercises).
- Spinal tumors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohamed Helayel Marzouk, PhD contact
Egypt1 site
Faculty of physical therapy, Cairo University
Giza
Samar Adel Ibrahim Farahat, 01003186220, samaradelneuro@gmail.com
About this study
The purpose of the study is to determine the effect of kinetic control training on flexion relaxation phenomenon and craniovertebral angle in patients with cervical radiculopathy.
Read the detailed description
Neck pain is a major health issue with high rates of recurrence. The current literature suggests people with cervical pain have altered movement control strategies and that these changes are associated with pain and disability.
These altered strategies will influence the control of movement which can present as both uncontrolled translatatory movement and uncontrolled range or physiological motion. Either movement dysfunction will present clinically as areas of relative flexibility (increase in translational movement) or areas of relative stiffness.
Changes in alignment in the cervical spine may result in a forward head posture position demonstrating an increase in low cervical flexion.
The greater the forward head posture, the greater the disability. Regions and segments of less mobility have been noted in the cervical spine which will present clinically as regions of relative stiffness.
Disturbance in neck flexor synergy has been commonly observed in patients with neck pain. This disturbed neck flexor synergy presents as altered pattern of muscle activity, where impairment in deep cervical flexors appears to be compensated by increased activity in superficial muscles (sternocleidomastoid and anterior scalene) and it is also reported that the amplitude of upper trapezius and cervical extensors have been dramatically increased among those patients. Such impairments may contribute to the development of pain and disability in patients with neck pain.
The Kinetic Control retraining strategy consists of patient education about his uncontrolled movement, retraining the coordination of movement direction control and muscle synergy retraining. Movement retraining interventions that are matched to correcting specific impairments can restore movement and performance solutions, elevating movement health and the quality of life it supports.
- Conditions
- Cervical Radiculopathy
- Being tested
- Conventional physical therapy program, Kinetic control training
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physical therapy programOther
The conventional physical therapy program will be received for 8 weeks by the two groups. It includes the application of moist heat using a hot pack for ten minutes, followed by continuous ultrasound therapy operated at a frequency of 1 MHz and an intensity of 1.5 W/cm² for five minutes. Transcutaneous Electrical Nerve Stimulation (TENS) will also be utilized, with its development and application based on the Gate Control Theory. TENS will be applied for twenty minutes, with electrodes positioned on either side of the neck at the level of pain, using a pulse rate ranging from 2 to 50 Hz.
Kinetic control trainingOther
The Kinetic Control Retraining Program will be received for 8 weeks by the experimental group. It focuses on addressing uncontrolled movement (UCM) and muscle synergy retraining. UCM retraining starts with patient education on movement deficiencies, their symptoms, and adherence to training. Movement coordination is retrained in test positions, progressing to challenging ones using feedback from mirrors, walls, or hands. Corrections focus on lower cervical flexion, upper cervical extension, mid-cervical translation/extension, side-bending, and rotation, emphasizing controlled dissociation in supported and unsupported postures. Muscle synergy retraining targets global stabilizers (e.g., deep neck flexors and extensors) and mobilizers (e.g., sternocleidomastoid and suboccipital muscles) to enhance coordination, stability, and motor control.
| Study group | Role | What they receive |
|---|---|---|
| Conventional physical therapy program | Active comparator | It consists of thirty patients with cervical radiculopathy. They will receive conventional physical therapy program. Receives: Other: Conventional physical therapy program |
| Conventional physical therapy program + Kinetic control training | Experimental | It consists of thirty patients with cervical radiculopathy. They will receive conventional physical therapy program plus kinetic control training. Receives: Other: Conventional physical therapy program; Other: Kinetic control training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain
The Visual analogue scale is used for pain assessment. In this scale, pain is rated from 0 to 100 mm, in which the 0 represented no pain and100 Represented maximum pain tolerance. Subjects are indicated the best number described their pain.
Measured: 8 weeks
Assessment of craniovertebral angle (CVA)
Markus Bader ruler (MB ruler) is a computer-based objective tool that measure angles and distances. Reflective markers will be placed on participants' anatomical landmarks and a photograph will be taken. The photograph will be uploaded to a computer and the MB ruler software will be used to calculate the CVA.
Measured: 8 weeks
Assessment of flexion relaxation phenomenon using surface electromyography
Cervical flexion relaxation phenomenon (FRP) is a myoelectric silence of neck extensor muscles which occurs after a certain degree of flexion. Patients will accomplish cervical flexion and extension from a neutral position in four phases in the sitting position. The surface electromyography activity of cervical erector spinae (CES) will be recorded in each phase.
Measured: 8 weeks
Secondary outcomes (1)
Assessment of disability
The Neck Disability Index (NDI), a modification of the Oswestry Low Back Pain Disability Index, is a widely used instrument for measuring self-rated disability due to neck pain, utilized by clinicians and researchers alike. It is a condition-specific, patient-completed functional status questionnaire consisting of 10 items: pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Each item is scored from 0 to 5, with a maximum score of 50. The total score can be multiplied by two to yield a percentage score, providing a standardized measure of disability.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start15 Dec 2024 (estimated)
- Primary completion15 Feb 2025 (estimated)
- Study completion22 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Adel Ibrahim Farahat, Cairo University
- Investigators
- Eman Samir Mohamed Fayez, PhD, Study chair, Professor, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732037
- Sponsor's protocol ID
- P.T.REC/012/004384
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinetic Control Training on Flexion Relaxation Phenomenon and Craniovertebral Angle in Cervical Radiculopathy Patients
- ClinicalTrials.gov ID
- NCT06732037
- Acronym / sponsor ID
- P.T.REC/012/004384
- Conditions
- Cervical Radiculopathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 22 Feb 2025 (estimated)
- First posted
- 13 Dec 2024 (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.
The purpose of the study is to determine the effect of kinetic control training on flexion relaxation phenomenon and craniovertebral angle in patients with cervical radiculopathy.
Detailed description
Neck pain is a major health issue with high rates of recurrence. The current literature suggests people with cervical pain have altered movement control strategies and that these changes are associated with pain and disability.
These altered strategies will influence the control of movement which can present as both uncontrolled translatatory movement and uncontrolled range or physiological motion. Either movement dysfunction will present clinically as areas of relative flexibility (increase in translational movement) or areas of relative stiffness.
Changes in alignment in the cervical spine may result in a forward head posture position demonstrating an increase in low cervical flexion.
The greater the forward head posture, the greater the disability. Regions and segments of less mobility have been noted in the cervical spine which will present clinically as regions of relative stiffness.
Disturbance in neck flexor synergy has been commonly observed in patients with neck pain. This disturbed neck flexor synergy presents as altered pattern of muscle activity, where impairment in deep cervical flexors appears to be compensated by increased activity in superficial muscles (sternocleidomastoid and anterior scalene) and it is also reported that the amplitude of upper trapezius and cervical extensors have been dramatically increased among those patients. Such impairments may contribute to the development of pain and disability in patients with neck pain.
The Kinetic Control retraining strategy consists of patient education about his uncontrolled movement, retraining the coordination of movement direction control and muscle synergy retraining. Movement retraining interventions that are matched to correcting specific impairments can restore movement and performance solutions, elevating movement health and the quality of life it supports.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional physical therapy program | Active comparator | Other: Conventional physical therapy programIt consists of thirty patients with cervical radiculopathy. They will receive conventional physical therapy program. |
| Conventional physical therapy program + Kinetic control training | Experimental | Other: Conventional physical therapy program, Other: Kinetic control trainingIt consists of thirty patients with cervical radiculopathy. They will receive conventional physical therapy program plus kinetic control training. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients will be referred from neurologist with the diagnosis cervical spondylosis.
- Patients will be included if they have unilateral radiculopathy due to spondylotic changes of the lower cervical spine (C5-C6 and C6-C7).
- Duration of symptoms is more than three months to avoid acute stage of inflammation.
- Patient's age ranged from 40 to 55 years.
- Patients from both sexes.
Key exclusion criteria (6 listed)
- Spinal canal stenosis.
- Rheumatoid arthritis.
- Vertebrobasilar insufficiency.
- Spinal instability due to structural cause e.g., spondylolisthesis.
- Systemic disease (cardiovascular, infectious and/or metabolic disease that could interrupt exercises).
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 |
|---|---|---|
| Conventional physical therapy programThe conventional physical therapy program will be received for 8 weeks by the two groups. It includes the application of moist heat using a hot pack for ten minutes, followed by continuous ultrasound therapy operated at a frequency of 1 MHz and an intensity of 1.5 W/cm² for five minutes. Transcutaneous Electrical Nerve Stimulation (TENS) will also be utilized, with its development and application based on the Gate Control Theory. TENS will be applied for twenty minutes, with electrodes positioned on either side of the neck at the level of pain, using a pulse rate ranging from 2 to 50 Hz. | Other | Conventional physical therapy program, Conventional physical therapy program + Kinetic control training |
| Kinetic control trainingThe Kinetic Control Retraining Program will be received for 8 weeks by the experimental group. It focuses on addressing uncontrolled movement (UCM) and muscle synergy retraining. UCM retraining starts with patient education on movement deficiencies, their symptoms, and adherence to training. Movement coordination is retrained in test positions, progressing to challenging ones using feedback from mirrors, walls, or hands. Corrections focus on lower cervical flexion, upper cervical extension, mid-cervical translation/extension, side-bending, and rotation, emphasizing controlled dissociation in supported and unsupported postures. Muscle synergy retraining targets global stabilizers (e.g., deep neck flexors and extensors) and mobilizers (e.g., sternocleidomastoid and suboccipital muscles) to enhance coordination, stability, and motor control. | Other | Conventional physical therapy program + Kinetic control training |
Primary outcome
Assessment of pain
Time frame: 8 weeks
The Visual analogue scale is used for pain assessment. In this scale, pain is rated from 0 to 100 mm, in which the 0 represented no pain and100 Represented maximum pain tolerance. Subjects are indicated the best number described their pain.
Assessment of craniovertebral angle (CVA)
Time frame: 8 weeks
Markus Bader ruler (MB ruler) is a computer-based objective tool that measure angles and distances. Reflective markers will be placed on participants' anatomical landmarks and a photograph will be taken. The photograph will be uploaded to a computer and the MB ruler software will be used to calculate the CVA.
Assessment of flexion relaxation phenomenon using surface electromyography
Time frame: 8 weeks
Cervical flexion relaxation phenomenon (FRP) is a myoelectric silence of neck extensor muscles which occurs after a certain degree of flexion. Patients will accomplish cervical flexion and extension from a neutral position in four phases in the sitting position. The surface electromyography activity of cervical erector spinae (CES) will be recorded in each phase.
1 secondary outcome
Assessment of disability
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
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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.
Mohamed Helayel Marzouk, PhD contact
Eman Samir Mohamed Fayez, PhD study chair
Professor, Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional physical therapy program in people with Cervical Radiculopathy, run by Cairo University at 1 site in Egypt.
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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samar Adel Ibrahim Farahat, M.Sc (01003186220, samaradelneuro@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pain (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 24 Dec 2024.