Marmara University Pendik Training and Research Hospital
Pendik, Istanbul, 34890, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07307846
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Pendik, Istanbul, 34890, Turkey (Türkiye)
Location status: Recruiting
Cervical radiculopathy is characterized by neuropathic pain radiating along a dermatomal pattern due to irritation or compression of cervical nerve roots, most commonly from cervical disc herniation or foraminal narrowing. In addition to sensory symptoms, proprioceptive deficits may arise from altered cervical afferent input, affecting upper extremity joint position sense and sensorimotor control. Although proprioceptive impairment has been previously demonstrated in chronic neck pain and cervical spondylosis, the proprioceptive profile of patients with cervical radiculopathy has not been adequately investigated.
Interlaminar epidural steroid injection (ILESI) is a commonly used minimally invasive treatment for cervical disc herniation-associated radicular pain and has been shown to reduce pain and improve function and disability. However, its potential effects on upper extremity proprioception, an important sensory component contributing to coordinated movement and rehabilitation outcomes, remain unknown.
This prospective interventional study will evaluate proprioceptive changes using the PRO-Reach upper extremity joint position sense test, a validated multi-planar assessment method that measures joint position error across multiple directions without requiring computerized or robotic devices. Clinical outcome measures will include neuropathic pain scores, pain intensity, disability indices, hand-grip strength, and health-related quality of life. All assessments will be performed at three time points: before treatment (T0), 3 weeks after injection (T1), and 3 months after injection (T2).
Participants will undergo standardized unilateral ILESI at the C7-T1 interlaminar level under fluoroscopic guidance using a combination of corticosteroid, local anesthetic, and saline. Data collection will be performed by blinded assessors to minimize measurement bias.
The study aims to characterize whether ILESI provides measurable improvements in upper extremity proprioception and to determine the extent to which changes in proprioceptive accuracy correspond to changes in pain, neuropathic symptoms, upper extremity function, and quality of life. These findings may help guide rehabilitation planning and provide insight into the sensorimotor consequences of cervical radiculopathy and its interventional treatment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants must meet all of the following:
Exclusion criteria
Participants will be excluded for any of the following:
Withdrawal Criteria
The 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.
Time frame: Baseline (T0), 3 weeks after ILESI (T1), and 3 months after ILESI (T2)
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.
Time frame: Baseline (T0), 3 weeks after ILESI (T1), and 3 months after ILESI (T2)
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.
Time frame: Baseline (T0), 3 weeks after ILESI (T1), and 3 months after ILESI (T2)
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.
Time frame: Baseline (T0), 3 weeks after ILESI (T1), and 3 months after ILESI (T2)
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.
Time frame: Baseline (T0), 3 weeks after ILESI (T1), and 3 months after ILESI (T2)
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.
Time frame: Baseline (T0), 3 weeks after ILESI (T1), and 3 months after ILESI (T2)
Upper extremity function and disability will be evaluated using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. Scores range from 0 to 100, with higher scores indicating greater disability. The outcome is the change in QuickDASH score over time.
Contact information is provided by the study sponsor or research team.
Marmara University
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