Cervical RadiculopathyNCT07307846
Investigation of the Effects of Interlaminar Epidural Steroid Injection on Upper Extremity Proprioception in Patients With Chronic Cervical Radiculopathy
A study testing Interlaminar Epidural Steroid Injection (ILESI) in people with Cervical Radiculopathy and Cervical Radicular Pain, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical Radiculopathy, Cervical Radicular Pain, Proprioception
- What is being tested?
- Interlaminar Epidural Steroid Injection (ILESI)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2026to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
- Known allergy to any components of the planned injection (triamcinolone, lidocaine, saline, contrast medium)
- Pregnancy
- Inability or unwillingness to provide informed consent
- Illiteracy (unable to read or write)
- Withdrawal Criteria
- Voluntary withdrawal of consent at any time
- Inability or unwillingness to continue study participation for any reason
- New medical condition or event after enrollment that renders continuation unsafe according to the investigator's judgment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University Pendik Training and Research Hospital
Pendik, Istanbul, 34890
Gökçenur Yalçın, M.D., PMR Specialist, +90 216 625 45 45, gokce_cihaner@hotmail.com
About this study
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.
Read the detailed description
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.
- Being tested
- Interlaminar Epidural Steroid Injection (ILESI)
- Keywords
- cervical radiculopathy, cervical radicular pain, interlaminar epidural steroid injection, proprioception, proprioceptive impairment
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interlaminar Epidural Steroid Injection (ILESI)Procedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Interlaminar Epidural Steroid Injection (ILESI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0), 3 weeks after ILESI (T1), and 3 months after ILESI (T2)
Secondary outcomes (5)
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.
Measured: Baseline (T0), 3 weeks after ILESI (T1), and 3 months after ILESI (T2)
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.
Measured: Baseline (T0), 3 weeks after ILESI (T1), and 3 months after ILESI (T2)
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.
Measured: Baseline (T0), 3 weeks after ILESI (T1), and 3 months after ILESI (T2)
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.
Measured: Baseline (T0), 3 weeks after ILESI (T1), and 3 months after ILESI (T2)
Change in Upper Extremity Function (QuickDASH Score)
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.
Measured: Baseline (T0), 3 weeks after ILESI (T1), and 3 months after ILESI (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start5 Jan 2026 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Savaş Şencan, Assoc. Prof., Pain Medicine, Study director, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307846
- Sponsor's protocol ID
- Marmara-FTR-GNY-03
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Interlaminar Epidural Steroid Injection on Upper Extremity Proprioception in Patients With Chronic Cervical Radiculopathy
- ClinicalTrials.gov ID
- NCT07307846
- Acronym / sponsor ID
- Marmara-FTR-GNY-03
- Keywords
- cervical radiculopathy, cervical radicular pain, interlaminar epidural steroid injection, proprioception, proprioceptive impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 5 Jan 2026 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical Radiculopathy- Interlaminar Epidural Steroid Injection (ILESI) Group | Active comparator | Procedure: Interlaminar Epidural Steroid Injection (ILESI)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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interlaminar Epidural Steroid Injection (ILESI)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. | Procedure or surgery | Cervical Radiculopathy- Interlaminar Epidural Steroid Injection (ILESI) Group |
Primary outcome
Change in Upper Extremity Proprioception Error (PRO-Reach)
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.
5 secondary outcomes
Change in Neuropathic Pain Score (DN-4)
Time frame: Baseline (T0), 3 weeks after ILESI (T1), and 3 months after ILESI (T2)
Change in Pain Intensity (Numeric Rating Scale, NRS 0-10)
Time frame: Baseline (T0), 3 weeks after ILESI (T1), and 3 months after ILESI (T2)
Change in Health-Related Quality of Life (SF-12)
Time frame: Baseline (T0), 3 weeks after ILESI (T1), and 3 months after ILESI (T2)
Change in Hand-Grip Strength (kg)
Time frame: Baseline (T0), 3 weeks after ILESI (T1), and 3 months after ILESI (T2)
Change in Upper Extremity Function (QuickDASH Score)
Time frame: Baseline (T0), 3 weeks after ILESI (T1), and 3 months after ILESI (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Savaş Şencan, Assoc. Prof., Pain Medicine study director
Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interlaminar Epidural Steroid Injection (ILESI) in people with Cervical Radiculopathy and Cervical Radicular Pain, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gökçenur Yalçın, M.D., PMR Specialist (+90 216 625 45 45, gokce_cihaner@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Upper Extremity Proprioception Error (PRO-Reach) (time frame: Baseline (T0), 3 weeks after ILESI (T1), and 3 months after ILESI (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.