About this trial
Cervical radiculopathy is a common condition caused by irritation or compression of cervical nerve roots, often leading to unilateral neuropathic pain and functional impairment. Proprioceptive deficits in the upper extremity have been demonstrated in various cervical spine disorders; however, the effect of interlaminar epidural steroid injection (ILESI) on upper extremity proprioception in patients with chronic cervical radiculopathy has not been previously examined.
This prospective interventional study aims to evaluate changes in upper extremity proprioception following unilateral ILESI in patients with cervical disc herniation-related chronic radiculopathy. A secondary aim is to investigate the relationship between proprioceptive changes and clinical outcomes such as pain, neuropathic pain, disability, grip strength, and quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female or male, 18-65 years of age
Presence of unilateral cervical radicular pain lasting at least 3 months
MRI of the cervical spine within the last 12 months demonstrating at least one cervical disc herniation consistent with the patient's symptoms
Diagnosed with chronic cervical radiculopathy based on history, physical examination, and clinical evaluation
Disqualifiers
Cervical physical therapy or cervical spinal injection performed within the past 6 months
Symptoms or diagnosis of upper extremity entrapment neuropathy
Documented vitamin B12 deficiency or vitamin D deficiency on laboratory results within the past year
History of cervical spine surgery or significant cervical trauma
Trial design
Single group
Treatments tested in this trial
Interlaminar Epidural Steroid Injection (ILESI)
Procedure/SurgeryThe injection will be administered under sterile conditions with fluoroscopic guidance at the C7-T1 interlaminar level. An 18-gauge epidural needle will be advanced into the epidural space, followed by injection of a mixture containing: 80 mg triamcinolone acetonide, 1 mL of 2% lidocaine, and 2 mL of 0.9% saline. Participants will remain under observation for approximately 2 hours after the procedure and will then be discharged. The procedure will be performed by an experienced pain medicine specialist with over 15 years of fluoroscopic interventional practice.
Treatment groups
Trial outcomes
Primary outcomes
Change in Upper Extremity Proprioception Error (PRO-Reach)
Upper extremity joint position sense will be assessed using the PRO-Reach test, which quantifies position error (distance in centimeters between the target and reproduced position) across multiple reaching directions. The primary outcome is the change in mean position error of the affected upper extremity between baseline and follow-up assessments. Higher values indicate poorer proprioceptive accuracy.
Secondary outcomes
Change in Neuropathic Pain Score (DN-4)
Neuropathic pain symptoms will be evaluated using the Douleur Neuropathique 4 (DN-4) questionnaire. Scores range from 0 to 10, with scores ≥4 indicating the presence of neuropathic pain. The outcome is the change in DN-4 score over time.
Change in Pain Intensity (Numeric Rating Scale, NRS 0-10)
Pain intensity related to cervical radicular pain will be measured using an 11-point Numeric Rating Scale (NRS), where 0 represents "no pain" and 10 represents "worst imaginable pain." Neck and extremity pain will be recorded as two separate subscores. The outcome is the change in NRS score over time. Lower scores indicate less pain.
Change in Health-Related Quality of Life (SF-12)
Health-related quality of life will be assessed using the 12-Item Short Form Survey (SF-12), generating physical and mental component summary scores. Higher scores indicate better perceived health status, ranging between 0-100. The outcome is the change in SF-12 scores over time.
Change in Hand-Grip Strength (kg)
Maximal isometric hand-grip strength will be measured using a dynamometer (e.g., Jamar) with the participant seated, elbow at 90° flexion, and wrist in neutral. Three trials will be performed for each hand, and the mean value will be recorded in kilograms. The outcome is the change in grip strength of the affected side over time. Higher values indicate greater strength.
Sponsors and contacts
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