Investigation of the Effects of Interlaminar Epidural Steroid Injection on Upper Extremity Proprioception in Patients With Chronic Cervical Radiculopathy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMarmara University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Interlaminar Epidural Steroid Injection (ILESI)

    Procedure/Surgery

    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.

Treatment groups

46 Participants
are divided into 1 treatment group
Group A: Cervical Radiculopathy- Interlaminar Epidural Steroid Injection (ILESI) GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (T0), 3 weeks after ILESI (T1), and 3 months after ILESI (T2)

Secondary outcomes

1

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.

Time frame
Baseline (T0), 3 weeks after ILESI (T1), and 3 months after ILESI (T2)
2

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.

Time frame
Baseline (T0), 3 weeks after ILESI (T1), and 3 months after ILESI (T2)
3

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.

Time frame
Baseline (T0), 3 weeks after ILESI (T1), and 3 months after ILESI (T2)
4

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.

Time frame
Baseline (T0), 3 weeks after ILESI (T1), and 3 months after ILESI (T2)

Other outcomes

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