Effect of Kinetic Control Retraining on Neck Proprioception and Functional Outcome in Patients With Cervical Radiculopathy

NCT ID: NCT06803134

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2025-06-15

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Selected physical therapy program + Kinetic control retraining

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.

Group Type: EXPERIMENTAL

Selected physical therapy program

Intervention Type: OTHER

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 retraining

Intervention Type: OTHER

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.

Selected physical therapy program

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.

Group Type: ACTIVE_COMPARATOR

Selected physical therapy program

Intervention Type: OTHER

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.

Interventions

Selected physical therapy program

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.

Intervention Type: OTHER

Kinetic control retraining

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)..

Exclusion Criteria

• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ebtesam Wafik Osman Shehab El-Din

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nahed Ahmed Salem, PhD

Role: STUDY_CHAIR

Professor, Cairo university

Locations

Horus University

Damietta, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ebtesam Wafik Osman Shehab El-Din, M.Sc

Role: CONTACT

ebtsShehab96@gmail.com

+20 10 01447604

Nagwa Ibrahim Rehab, PhD

Role: CONTACT

Facility Contacts

Ebtesam Wafik Osman Shehab El-Din, M.Sc

Role: primary

ebtsShehab96@gmail.com

+20 10 01447604

Other Identifiers

P.T.REC/012/004919

Identifier Type: -

Identifier Source: org_study_id