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

NCT ID: NCT06732037

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-15

Study Completion Date

2025-02-22

Brief Summary

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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

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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

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Cervical Radiculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional physical therapy program

It consists of thirty patients with cervical radiculopathy. They will receive conventional physical therapy program.

Group Type ACTIVE_COMPARATOR

Conventional physical therapy program

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Conventional physical therapy program

Intervention Type OTHER

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 training

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Samar Adel Ibrahim Farahat

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eman Samir Mohamed Fayez, PhD

Role: STUDY_CHAIR

Professor, Cairo university

Locations

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Faculty of physical therapy, Cairo University

Giza, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Samar Adel Ibrahim Farahat, M.Sc

Role: CONTACT

Phone: 01003186220

Email: [email protected]

Mohamed Helayel Marzouk, PhD

Role: CONTACT

Facility Contacts

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Samar Adel Ibrahim Farahat

Role: primary

Other Identifiers

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P.T.REC/012/004384

Identifier Type: -

Identifier Source: org_study_id