Cervical RadiculopathyNCT06803134
Effect of Kinetic Control Retraining on Neck Proprioception and Functional Outcome in Patients With Cervical Radiculopathy
A study testing Selected physical therapy program in people with Cervical Radiculopathy, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to investigate the effect of kinetic control retraining on neck proprioception and functional outcome 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?
- Selected physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 15 Jun 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
- Forty Four patients suffering from chronic cervical unilateral radiculopathy (symptomatic duration) (3 months to 1year).
- Their age ranges 40-55 years, from both sexes.
- Body mass index (BMI) of less than 30 Kg/m2
- Cervical spondylosis (at the levels of C5-C6/C6-C7 confirmed by cervical MRI)..
Who cannot join
- Cervical myelopathy with evidence of pyramidal, posterior column, and or spinothalamic tract lesions.
- Patients with decreased range of motion of cervical spine secondary to congenital anomalies, musculature contracture, or bony block.
- Previous cervical or shoulder surgery or trauma.
- Cervical instability caused by structural problem (e.g. ligament tear or spondylolithesis.
- Psychological problems interfering with the patient understanding of the orders, or patients who did not have direction preference.
- Vertebro-basilar artery insufficiency, diabetic neuropathy.
- Comorbidities that impact physical activity (e.g., cerebrovascular accidents, severe heart disease). - Double crush syndrome and thoracic outlet syndrome.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nagwa Ibrahim Rehab, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Horus University
Damietta
Ebtesam Wafik Osman Shehab El-Din, M.Sc, +20 10 01447604, ebtsShehab96@gmail.com
About this study
The aim of this study is to investigate the effect of kinetic control retraining on neck proprioception and functional outcome in patients with cervical radiculopathy.
Read the detailed description
Cervical radiculopathy (CR), which is a normal result of degenerative changes such as cervical disc herniation and bone hyperplasia, is characterized by neck pain and radiating pain from the neck to the shoulder. Neck pain has a major physical, psychological, and socioeconomic impact, as it is the fourth most frequent cause of disability, preceded of low back pain, depression, and arthralgia. In fact, up to 50-70% of the entire population will experience (at least) one episode of neck pain clinically important throughout their life.
Prolonged or recurring stress exposure, pain catastrophism, and fear-avoidance behaviors can trigger variable responses to pain thresholds" intolerance depending on the magnitude of the individual stress response.
Regular physical exercise is a key factor for the prevention of many chronic diseases. Physical exercise (PE) can be used as a primary non-pharmacological clinical tool because it can improve antioxidant capacity, reduce oxidative stress and inflammation and increase energy efficiency. Depending on the volume, the intensity and the frequency of exercise, acute or chronic biochemical and physiological responses are induced. Once movement meets control, they can regain the choices lost in the presence of pain and give people the optimal choice in how they move, these choices are lost with movement impairment. So, the movement value is a central theme in the physical therapy profession and functional concepts which build on movement therapy. These concepts are built on kinetic control approach. This study may add missing information to the existing literature and suggests directions for the effect of kinetic control retraining on neck proprioception and functional outcome in patients with cervical radiculopathy.
- Conditions
- Cervical Radiculopathy
- Being tested
- Selected physical therapy program, Kinetic control retraining
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selected physical therapy programOther
Both groups will receive a selected physical therapy program in the form of trans-cutaneous electrical nerve stimulation (TENS), moist hot pack, posture education, and strengthening exercises for deep neck flexors, for 30 minutes, 3 sessions per week, for 8 weeks.
Kinetic control retrainingOther
Each patient in the experimental group will receive kinetic control retraining for 30 minutes, 3 sessions per week, for 8 weeks. Each session is based on the progression on the motor control rating scale (MCRS) related to kinetic control management frame. For each movement direction, specific control tests will be conducted. The direction and site of the uncontrolled movement will be evaluated using special tests in accordance with the pain history of the patient. The tests will be chosen according to the patient"s symptoms; screening of all patients will be done through at least three tests in each direction according to the patient"s symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Selected physical therapy program + Kinetic control retraining | Experimental | Participants in this group will be treated by kinetic control retraining for 30 minutes in addition to selected physical therapy program for 30 minutes, 3 sessions per week (day after day), for 8 weeks. Receives: Other: Selected physical therapy program; Other: Kinetic control retraining |
| Selected physical therapy program | Active comparator | Participants in this group will be treated by the same selected physical therapy program for 30 minutes, 3 sessions per week (day after day), for 8 weeks. Receives: Other: Selected physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of cervical proprioception using the cervical range of motion (CROM) device
Cervical proprioception will be assessed using the CROM device. Subjects will sit upright in a neutral head position with their trunk and shoulders secured by Velcro straps and will be blindfolded. The CROM unit will be calibrated to zero and secured on the head, with the magnetic yoke positioned on the shoulder. Two tests will be conducted: the Neutral Head Repositioning Test (NHR), where subjects rotate their heads left and return to neutral with accuracy measured in degrees, and the Target Head Repositioning Test (THR), where cervical range of motion will be tested, and subjects will reproduce a memorized target position. Each test will be repeated three times, with average angular displacement error calculated.
Measured: 8 weeks
Assessment of deep neck flexors (DNFs) strength by craniocervical flexion test (CCFT) using pressure biofeedback unit (PBU)
The craniocervical flexion test, a valid and reliable tool for assessing deep neck flexor (DNF) muscle performance, involves positioning the participant in a crook-lying position with a pressure biofeedback unit (PBU) placed under the head. The participant holds the PBU's dial to guide the test, which progresses through five stages based on the pressure exerted at a neutral head position (22, 24, 26, 28, and 30 mmHg). Starting at 20 mmHg, participants perform a slow head nod to incrementally increase the pressure by 2 mmHg, holding each increment for three seconds. Baseline performance is the maximum pressure held correctly for three seconds without substitution, monitored by the tester through palpation of superficial flexors.
Measured: 8 weeks
Secondary outcomes (2)
Evaluation of neck pain intensity using the Visual Analogue Scale (VAS)
The subject will be asked to make a handwritten mark on a 100 mm line (10cm). This line represents a continuum between no pain or discomfort (zero), to the worst pain (10) that the patient could feel. Measurements from the starting point of the scale to the patients' marks will be recorded and interpreted as their pain intensity. The results will be interpreted as: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Measured: 8 weeks
Evaluation of neck-related functional performance using the Arabic version of Neck Disability Index (NDI)
The patient will answer each question by marking the box that best describes their problem, using a six-point scale from 0 (no disability) to 5 (major disability). The total score, out of 50, will be calculated by summing the item scores, with higher scores indicating greater disability. The results will be interpreted as follows: 0-4 = no disability, 5-14 = mild disability, 15-24 = moderate disability, 25-34 = severe disability, and above 34 = complete 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 posted31 Jan 2025
- Study start1 Feb 2025
- Primary completion1 Jun 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebtesam Wafik Osman Shehab El-Din, Cairo University
- Investigators
- Nahed Ahmed Salem, PhD, Study chair, Professor, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803134
- Sponsor's protocol ID
- P.T.REC/012/004919
- Status last verified
- Apr 2025
- First submitted
- 27 Jan 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shehab EW, Salem NA, Ahmed S, Elsherif AA, Rehab NI. Effect of Kinetic Control Retraining on Neck Proprioception and Function in Cervical Radiculopathy: A Randomized Controlled Trial. J Musculoskelet Neuronal Interact. 2026 Mar 1;26(1):97-107. doi: 10.22540/JMNI-26-097.
PubMed 41764757
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinetic Control Retraining on Neck Proprioception and Functional Outcome in Patients With Cervical Radiculopathy
- ClinicalTrials.gov ID
- NCT06803134
- Acronym / sponsor ID
- P.T.REC/012/004919
- Conditions
- Cervical Radiculopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 31 Jan 2025 (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 aim of this study is to investigate the effect of kinetic control retraining on neck proprioception and functional outcome in patients with cervical radiculopathy.
Detailed description
Cervical radiculopathy (CR), which is a normal result of degenerative changes such as cervical disc herniation and bone hyperplasia, is characterized by neck pain and radiating pain from the neck to the shoulder. Neck pain has a major physical, psychological, and socioeconomic impact, as it is the fourth most frequent cause of disability, preceded of low back pain, depression, and arthralgia. In fact, up to 50-70% of the entire population will experience (at least) one episode of neck pain clinically important throughout their life.
Prolonged or recurring stress exposure, pain catastrophism, and fear-avoidance behaviors can trigger variable responses to pain thresholds" intolerance depending on the magnitude of the individual stress response.
Regular physical exercise is a key factor for the prevention of many chronic diseases. Physical exercise (PE) can be used as a primary non-pharmacological clinical tool because it can improve antioxidant capacity, reduce oxidative stress and inflammation and increase energy efficiency. Depending on the volume, the intensity and the frequency of exercise, acute or chronic biochemical and physiological responses are induced. Once movement meets control, they can regain the choices lost in the presence of pain and give people the optimal choice in how they move, these choices are lost with movement impairment. So, the movement value is a central theme in the physical therapy profession and functional concepts which build on movement therapy. These concepts are built on kinetic control approach. This study may add missing information to the existing literature and suggests directions for the effect of kinetic control retraining on neck proprioception and functional outcome in patients with cervical radiculopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selected physical therapy program + Kinetic control retraining | Experimental | Other: Selected physical therapy program, Other: Kinetic control retrainingParticipants in this group will be treated by kinetic control retraining for 30 minutes in addition to selected physical therapy program for 30 minutes, 3 sessions per week (day after day), for 8 weeks. |
| Selected physical therapy program | Active comparator | Other: Selected physical therapy programParticipants in this group will be treated by the same selected physical therapy program for 30 minutes, 3 sessions per week (day after day), for 8 weeks. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Forty Four patients suffering from chronic cervical unilateral radiculopathy (symptomatic duration) (3 months to 1year).
- Their age ranges 40-55 years, from both sexes.
- Body mass index (BMI) of less than 30 Kg/m2
- Cervical spondylosis (at the levels of C5-C6/C6-C7 confirmed by cervical MRI)..
Key exclusion criteria (7 listed)
- Cervical myelopathy with evidence of pyramidal, posterior column, and or spinothalamic tract lesions.
- Patients with decreased range of motion of cervical spine secondary to congenital anomalies, musculature contracture, or bony block.
- Previous cervical or shoulder surgery or trauma.
- Cervical instability caused by structural problem (e.g. ligament tear or spondylolithesis.
- Psychological problems interfering with the patient understanding of the orders, or patients who did not have direction preference.
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 |
|---|---|---|
| Selected physical therapy programBoth groups will receive a selected physical therapy program in the form of trans-cutaneous electrical nerve stimulation (TENS), moist hot pack, posture education, and strengthening exercises for deep neck flexors, for 30 minutes, 3 sessions per week, for 8 weeks. | Other | Selected physical therapy program, Selected physical therapy program + Kinetic control retraining |
| Kinetic control retrainingEach patient in the experimental group will receive kinetic control retraining for 30 minutes, 3 sessions per week, for 8 weeks. Each session is based on the progression on the motor control rating scale (MCRS) related to kinetic control management frame. For each movement direction, specific control tests will be conducted. The direction and site of the uncontrolled movement will be evaluated using special tests in accordance with the pain history of the patient. The tests will be chosen according to the patient"s symptoms; screening of all patients will be done through at least three tests in each direction according to the patient"s symptoms. | Other | Selected physical therapy program + Kinetic control retraining |
Primary outcome
Evaluation of cervical proprioception using the cervical range of motion (CROM) device
Time frame: 8 weeks
Cervical proprioception will be assessed using the CROM device. Subjects will sit upright in a neutral head position with their trunk and shoulders secured by Velcro straps and will be blindfolded. The CROM unit will be calibrated to zero and secured on the head, with the magnetic yoke positioned on the shoulder. Two tests will be conducted: the Neutral Head Repositioning Test (NHR), where subjects rotate their heads left and return to neutral with accuracy measured in degrees, and the Target Head Repositioning Test (THR), where cervical range of motion will be tested, and subjects will reproduce a memorized target position. Each test will be repeated three times, with average angular displacement error calculated.
Assessment of deep neck flexors (DNFs) strength by craniocervical flexion test (CCFT) using pressure biofeedback unit (PBU)
Time frame: 8 weeks
The craniocervical flexion test, a valid and reliable tool for assessing deep neck flexor (DNF) muscle performance, involves positioning the participant in a crook-lying position with a pressure biofeedback unit (PBU) placed under the head. The participant holds the PBU's dial to guide the test, which progresses through five stages based on the pressure exerted at a neutral head position (22, 24, 26, 28, and 30 mmHg). Starting at 20 mmHg, participants perform a slow head nod to incrementally increase the pressure by 2 mmHg, holding each increment for three seconds. Baseline performance is the maximum pressure held correctly for three seconds without substitution, monitored by the tester through palpation of superficial flexors.
2 secondary outcomes
Evaluation of neck pain intensity using the Visual Analogue Scale (VAS)
Time frame: 8 weeks
Evaluation of neck-related functional performance using the Arabic version of Neck Disability Index (NDI)
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 30 Apr 2025.
- Derived from this study: PubMed 41764757Shehab EW, Salem NA, Ahmed S, Elsherif AA, Rehab NI. Effect of Kinetic Control Retraining on Neck Proprioception and Function in Cervical Radiculopathy: A Randomized Controlled Trial. J Musculoskelet Neuronal Interact. 2026 Mar 1;26(1):97-107. doi: 10.22540/JMNI-26-097.
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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.
Nagwa Ibrahim Rehab, PhD contact
Nahed Ahmed Salem, 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 Selected 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 30 Apr 2025. 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 Ebtesam Wafik Osman Shehab El-Din, M.Sc (+20 10 01447604, ebtsShehab96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of cervical proprioception using the cervical range of motion (CROM) device (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06803134, which also lists 1 linked publication.
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 30 Apr 2025.