Clinical trial NCT06923085: Upper Extremity Dysfunction in Patients With Cervical Radiculopathy
Official title: Bilateral Sensorimotor Dysfunction in the Upper Extremities in Unilateral Cervical Radiculopathies: A Level-Specific Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Radiculopathy
Lead sponsor: University of Beykent
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This prospective study will include patients with cervical radiculopathy (CR) and a control group with mechanical neck pain. Participants aged 18 to 65 years will be recruited from X Hospital. CR diagnosis will be confirmed by medical history, physical examination, and MRI findings. Patients will be categorized into three subgroups based on the affected cervical level: C4-5 (C5), C5-6 (C6), and C6-7 (C7). Exclusion criteria will include systemic or neurological disorders (excluding CR), previous spinal surgery, acute trauma, fracture, malignancy, osteoporosis, rheumatic disease, or ongoing treatment for chronic neck pain. Only patients with neck pain for at least three months will be eligible. MRI findings, dermatome mapping, and physical examination will be used to determine the primary affected level in cases of overlapping symptoms.

Brief summary: This study will examine how cervical radiculopathy (a pinched nerve in the neck) affects function in both arms, not just the symptomatic side. The investigators will evaluate 42 patients with different cervical nerve root involvement (C4-5, C5-6, or C6-7) and compare them to 16 control subjects with non-specific neck pain. The assessments will measure muscle strength, sensory function, hand performance, pain levels, and psychological factors. These evaluations may contribute to the development of rehabilitation programs for cervical radiculopathy.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* Clinical diagnosis of unilateral cervical radiculopathy at C4-5, C5-6, or C6-7 level
* Diagnosis confirmed by clinical examination and MRI
* Symptoms present for at least 4 weeks prior to enrollment
* Ability to understand and follow study instructions
* Ability to provide informed consent for participation
* For control group: non-specific neck pain without radiculopathy
* Ability to complete required assessments

Exclusion Criteria:

* Systemic disorders
* Neurological disorders (excluding CR)
* Previous spinal surgery
* Acute trauma
* Fracture
* Malignancy
* Osteoporosis
* Rheumatic disease
* Ongoing pharmacological treatment for chronic neck pain

Primary outcomes:
measure: Muscle Strength
timeFrame: Single assessment at study enrollment
Secondary outcomes:
measure: Light Touch Sensation
timeFrame: Single assessment at study enrollment
measure: Vibration Sense
timeFrame: Single assessment at study enrollment
measure: Upper Extremity Function
timeFrame: Single assessment at study enrollment
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Beykent University
state: None Selected
Study officials:
References: