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

NCT06732037 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/004384
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Radiculopathy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Assessment of disability

  8 weeks

Study Arms (2)

Conventional physical therapy program

ACTIVE COMPARATOR

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

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.

Other: Conventional physical therapy program; Other: Kinetic control training

Interventions

Conventional physical therapy program 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; Conventional physical therapy program + Kinetic control training

Kinetic control training 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.

Conventional physical therapy program + Kinetic control training

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy, Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Eman Samir Mohamed Fayez, PhD

  Professor, Cairo university

  STUDY CHAIR

Central Study Contacts

Samar Adel Ibrahim Farahat, M.Sc

CONTACT

01003186220; samaradelneuro@gmail.com

Mohamed Helayel Marzouk, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: December 15, 2024
• Primary Completion: February 15, 2025
• Study Completion: February 22, 2025
• Last Updated: December 24, 2024

Record last verified: 2024-12

Locations

EG (1)