Clinical trial NCT06803134: Effect of Kinetic Control Retraining on Neck Proprioception and Functional Outcome in Patients With Cervical Radiculopathy
Official title: Effect of Kinetic Control Retraining on Neck Proprioception and Functional Outcome in Patients With Cervical Radiculopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Radiculopathy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Evaluation of cervical proprioception using the cervical range of motion (CROM) device
timeFrame: 8 weeks
measure: Assessment of deep neck flexors (DNFs) strength by craniocervical flexion test (CCFT) using pressure biofeedback unit (PBU)
timeFrame: 8 weeks
Secondary outcomes:
measure: Evaluation of neck pain intensity using the Visual Analogue Scale (VAS)
timeFrame: 8 weeks
measure: Evaluation of neck-related functional performance using the Arabic version of Neck Disability Index (NDI)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Horus University
Study officials:
affiliation: Professor, Cairo university
name: Nahed Ahmed Salem, PhD
role: STUDY_CHAIR
References: