Effect of Kinetic Control Training on Flexion Relaxation Phenomenon and Craniovertebral Angle in Cervical Radiculopathy Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Radiculopathy
• Intervention / Treatment: Other: Conventional physical therapy program; Other: Kinetic control training

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samar Adel Ibrahim Farahat, M.Sc; Phone Number: 01003186220; Email: samaradelneuro@gmail.com
• Study Contact Backup: Name: Mohamed Helayel Marzouk, PhD

Study Locations

• Egypt
  • Giza, Egypt
    • Faculty of physical therapy, Cairo University
    • Contact: Samar Adel Ibrahim Farahat; Phone Number: 01003186220; Email: samaradelneuro@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients will be referred from neurologist with the diagnosis cervical spondylosis.
2. Patients will be included if they have unilateral radiculopathy due to spondylotic changes of the lower cervical spine (C5-C6 and C6-C7).
3. Duration of symptoms is more than three months to avoid acute stage of inflammation.
4. Patient's age ranged from 40 to 55 years.
5. Patients from both sexes.
6. Body mass index of all patients is ranged from 25-30 kg/m2.
7. 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

Exclusion Criteria:

1. Spinal canal stenosis.
2. Rheumatoid arthritis.
3. Vertebrobasilar insufficiency.
4. Spinal instability due to structural cause e.g., spondylolisthesis.
5. Systemic disease (cardiovascular, infectious and/or metabolic disease that could interrupt exercises).
6. Spinal tumors.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional physical therapy program; It consists of thirty patients with cervical radiculopathy. They will receive conventional physical therapy program.	Other: Conventional physical therapy program; 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.
Experimental: Conventional physical therapy program + Kinetic control training; It consists of thirty patients with cervical radiculopathy. They will receive conventional physical therapy program plus kinetic control training.	Other: Conventional physical therapy program; 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.; Other: Kinetic control training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Eman Samir Mohamed Fayez, PhD, Professor, Cairo university

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2024
• Primary Completion (Estimated): February 15, 2025
• Study Completion (Estimated): February 22, 2025

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Actual): December 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: P.T.REC/012/004384

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No