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

NCT07307846 | Recruiting

• 1 other identifier: Marmara-FTR-GNY-03
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Radiculopathy; Cervical Radicular Pain; Proprioception

Keywords

cervical radiculopathy; cervical radicular pain; interlaminar epidural steroid injection; proprioception; proprioceptive impairment

Outcome Measures

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.

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

Secondary Outcomes (5)

• Change in Neuropathic Pain Score (DN-4)

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

• Change in Pain Intensity (Numeric Rating Scale, NRS 0-10)

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

• Change in Health-Related Quality of Life (SF-12)

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

• Change in Hand-Grip Strength (kg)

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

• Change in Upper Extremity Function (QuickDASH Score)

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

Study Arms (1)

Cervical Radiculopathy- Interlaminar Epidural Steroid Injection (ILESI) Group

ACTIVE COMPARATOR

Participants diagnosed with chronic unilateral cervical radiculopathy due to cervical disc herniation will undergo a standardized interlaminar epidural steroid injection. All evaluations (proprioception, pain, neuropathic pain, disability, grip strength, and quality of life) will be performed at baseline (T0), 3 weeks post-procedure (T1), and 3 months post-procedure (T2).

Procedure: Interlaminar Epidural Steroid Injection (ILESI)

Interventions

Interlaminar Epidural Steroid Injection (ILESI) PROCEDURE

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.

Cervical Radiculopathy- Interlaminar Epidural Steroid Injection (ILESI) Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following:
• 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
• Ability to read and write (literacy)
• Willingness to participate and ability to provide written informed consent

You may not qualify if:

• Participants will be excluded for any of the following:
• 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
• Bilateral cervical radicular pain
• Cervical spinal stenosis
• History of upper extremity surgery or significant upper extremity trauma
• Cognitive impairment, major psychiatric disorder, intellectual disability, or history of significant neurological disease
• Diagnosis of polyneuropathy
• Diagnosis of Diabetes Mellitus
• Diagnosis of fibromyalgia
• Current use of medications that may impair proprioception or have sedative effects (e.g., gabapentinoids, antidepressants, muscle relaxants)
• Active local or systemic infection
• Coagulopathy or bleeding diathesis

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Pendik, Istanbul, 34890, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Savaş Şencan, Assoc. Prof., Pain Medicine

  Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine

  STUDY DIRECTOR

Central Study Contacts

Gökçenur Yalçın, M.D., PMR Specialist

CONTACT

+90 216 625 45 45; gokce_cihaner@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: January 5, 2026
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD and supporting documents will be available 6 months after publication of the main results and remain accessible for at least 5 years following publication.
• Access Criteria: Qualified researchers may request access to the de-identified dataset and supporting documentation by submitting a brief research proposal and data access agreement to the corresponding investigator (Gökçenur Yalçın, M.D., Department of Physical Medicine and Rehabilitation, Marmara University, Istanbul, Turkey). Data will be shared via a secure institutional data repository upon approval by the principal investigator and the Marmara University Ethics Committee.

Locations

TU (1)