Home-Based Exercise After Cervical Epidural Steroid Injection for Cervical Radiculopathy (CESI-HEP)

March 28, 2026 updated by: Banu Gokcen Baydogan Tan, Necmettin Erbakan University

Effect of a Home-Based Exercise Program After Cervical Interlaminar Epidural Steroid Injection on Clinical Outcomes in Patients With Chronic Cervical Radiculopathy: A Randomized Controlled Trial

Cervical radiculopathy is a common cause of neck and arm pain resulting from compression or inflammation of a cervical nerve root. Cervical epidural steroid injection is frequently used to reduce pain and improve function in patients who do not respond to conservative treatment. However, long-term functional recovery may require additional rehabilitation strategies. This randomized controlled trial aims to investigate whether adding a standardized home-based exercise program after cervical interlaminar epidural steroid injection improves pain, disability, sleep quality, and quality of life in patients with chronic cervical radiculopathy. Participants will be randomly assigned to receive either injection alone or injection followed by an eight-week home-based exercise program.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Chronic cervical radiculopathy is a common cause of neck and arm pain and may lead to significant disability, reduced quality of life, and sleep disturbances. Cervical epidural steroid injection is widely used to relieve radicular pain by reducing inflammation and nerve root irritation. Although injections may provide short-term pain relief, symptom recurrence and persistent functional limitations remain common.

Exercise-based rehabilitation is an important component of conservative management for cervical spine disorders. Initiating rehabilitation during the period of pain relief following injection may help improve neuromuscular function and enhance long-term recovery. However, structured rehabilitation after spinal injections is not consistently incorporated into routine clinical practice, particularly in interventional pain settings.

This prospective randomized controlled trial aims to evaluate the effectiveness of a standardized home-based exercise program initiated after cervical interlaminar epidural steroid injection in patients with chronic cervical radiculopathy. Participants will be randomly assigned to one of two groups: cervical epidural steroid injection alone or cervical epidural steroid injection followed by an eight-week home-based exercise program. The primary outcome will be neck-related disability assessed using the Neck Disability Index at 12 weeks. Secondary outcomes will include pain intensity, health-related quality of life, sleep quality, and analgesic medication use.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: BANU GOKCEN BAYDOGAN TAN, MEDICAL DOCTOR
  • Phone Number: +90095058174097
  • Email: baydogan.g@gmail.com

Study Locations

  • Turkey (Türkiye)
    • Turkey
      • Konya, Turkey, Turkey (Türkiye), 045
        • Recruiting
        • Necmettin Erbakan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18 and 70 years.
  • Chronic cervical radicular pain lasting ≥3 months, characterized by neck pain with accompanying arm pain consistent with a cervical nerve root distribution.
  • Average pain intensity ≥4/10 on the Numeric Rating Scale (NRS) over the preceding 7 days at baseline.
  • Diagnosis of chronic cervical radiculopathy due to cervical disc herniation, confirmed by clinical examination and cervical MRI findings at the corresponding level.
  • Insufficient response to conservative treatment, including physical therapy, medication, and/or exercise therapy.
  • Ability to provide written informed consent and comply with study procedures.

Exclusion Criteria:

  • Patients were excluded if any of the following were present:
  • Clinical signs of cervical myelopathy or progressive neurological deficit.
  • Suspicion of serious spinal pathology (e.g., infection, malignancy).
  • Contraindications to epidural steroid injection, including uncontrolled coagulopathy, anticoagulant therapy not appropriately managed, or local/systemic infection.
  • Pregnancy.
  • Prior cervical spine surgery or cervical epidural steroid injection within the prespecified washout period.
  • Severe musculoskeletal or neurological comorbidities that could interfere with safe participation in the exercise program.
  • Discordance between clinical symptoms and imaging findings.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: C-ILESI Only
Participants receive fluoroscopy-guided cervical interlaminar epidural steroid injection and standardized general advice without a structured exercise program.
Procedure: Cervical Interlaminar Epidural Steroid Injection
Fluoroscopy-guided cervical interlaminar epidural steroid injection performed at the C7-T1 interlaminar space using a paramedian approach. Epidural placement is confirmed with contrast medium under fluoroscopic visualization. A total of 8 mg dexamethasone is injected into the epidural space to reduce inflammation and nerve root irritation associated with cervical radiculopathy.
Experimental: C-ILESI + Home Exercise Program
Participants receive fluoroscopy-guided cervical interlaminar epidural steroid injection followed by an eight-week standardized home-based exercise program in addition to general advice.
Procedure: Cervical Interlaminar Epidural Steroid Injection
Fluoroscopy-guided cervical interlaminar epidural steroid injection performed at the C7-T1 interlaminar space using a paramedian approach. Epidural placement is confirmed with contrast medium under fluoroscopic visualization. A total of 8 mg dexamethasone is injected into the epidural space to reduce inflammation and nerve root irritation associated with cervical radiculopathy.
Behavioral: Home-Based Exercise Program
Participants perform a standardized home-based neck exercise program initiated after cervical epidural steroid injection and continued for 8 weeks. The program includes cervical mobility exercises, isometric strengthening exercises, deep cervical muscle activation, and stretching exercises targeting the upper trapezius and levator scapulae muscles. Exercises are performed five days per week for approximately 15-20 minutes per session. Participants receive initial supervised instruction and a printed exercise brochure to facilitate correct performance and adherence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck Disability Index (NDI)
Time Frame: The NDI was administered at baseline and at weeks 4, 8, and 12.
The primary outcome was the between-group difference in change in neck-related disability, assessed using the NDI, from baseline to week 12. The NDI is a validated, self-administered questionnaire consisting of 10 items evaluating pain intensity and functional limitations related to neck pain. Each item is scored on a 0-5 scale, yielding a total score ranging from 0 to 50, which was converted to a percentage score (0-100), with higher scores indicating greater disability. The NDI was administered at baseline and at weeks 4, 8, and 12.
The NDI was administered at baseline and at weeks 4, 8, and 12.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale (NRS)
Time Frame: Pain intensity was recorded at baseline and at weeks 2, 4, 8, and 12.
Pain intensity was assessed using a NRS for neck and arm pain, where 0 indicated "no pain" and 10 indicated "worst imaginable pain."
Pain intensity was recorded at baseline and at weeks 2, 4, 8, and 12.
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: PSQI was administered at baseline and at weeks 4,8 and 12.
Sleep quality was assessed using the PSQI, a validated self-administered questionnaire evaluating subjective sleep quality over the past month. The PSQI yields a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality.
PSQI was administered at baseline and at weeks 4,8 and 12.
The EuroQol five-dimension, five-level questionnaire (EQ-5D-5L)
Time Frame: EQ-5D-5L scores were obtained at baseline, week 4,8 and at week 12.
Health-related quality of life will be assessed using the EQ-5D-5L descriptive system. The index score is derived from five dimensions and ranges from values below 0 (worse than death) to 1 (perfect health). Higher scores indicate better health status.
EQ-5D-5L scores were obtained at baseline, week 4,8 and at week 12.
EuroQol Visual Analogue Scale (EQ-VAS)
Time Frame: The EQ-VAS scores were obtained at baseline, week 4,8 and at week 12.
The EQ-VAS records the patient's self-rated health on a vertical visual analogue scale ranging from 0 (worst imaginable health) to 100 (best imaginable health). Higher scores indicate better perceived health.
The EQ-VAS scores were obtained at baseline, week 4,8 and at week 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Necmettin Erbakan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

March 14, 2026

First Submitted That Met QC Criteria

March 28, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 28, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CESI-HEP-RCT-2026
  • Approval No: 2026-6375 (Registry Identifier: Necmettin Erbakan University Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data collected in this study will not be publicly shared due to institutional data protection policies and ethical considerations regarding patient confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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