Home-Based Exercise After Cervical Epidural Steroid Injection for Cervical Radiculopathy

NCT07506785 | Recruiting

• 2 other identifiers: CESI-HEP-RCT-2026Approval No: 2026-6375
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Radiculopathy; Home Based Rehabilitation

Keywords

Cervical Epidural Steroid Injection; Neck Pain; cervical radiculopathy; Home based exercise

Outcome Measures

Primary Outcomes (1)

• Neck Disability Index (NDI)

  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 Outcomes (4)

• Numeric Rating Scale (NRS)

  Pain intensity was recorded at baseline and at weeks 2, 4, 8, and 12.

• Pittsburgh Sleep Quality Index (PSQI)

  PSQI was administered at baseline and at weeks 4,8 and 12.

• The EuroQol five-dimension, five-level questionnaire (EQ-5D-5L)

  EQ-5D-5L scores were obtained at baseline, week 4,8 and at week 12.

• EuroQol Visual Analogue Scale (EQ-VAS)

  The EQ-VAS scores were obtained at baseline, week 4,8 and at week 12.

Study Arms (2)

C-ILESI Only

ACTIVE COMPARATOR

Participants receive fluoroscopy-guided cervical interlaminar epidural steroid injection and standardized general advice without a structured exercise program.

Procedure: Cervical Interlaminar Epidural Steroid Injection

C-ILESI + Home Exercise Program

EXPERIMENTAL

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; Behavioral: Home-Based Exercise Program

Interventions

Cervical Interlaminar Epidural Steroid Injection PROCEDURE

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.

C-ILESI + Home Exercise Program; C-ILESI Only

Home-Based Exercise Program BEHAVIORAL

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.

C-ILESI + Home Exercise Program

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University

Konya, Turkey, 045, Turkey (Türkiye)

RECRUITING

Related Publications (10)

• Daher A, Carel RS, Tzipi K, Esther H, Dar G. The effectiveness of an aerobic exercise training on patients with neck pain during a short- and long-term follow-up: a prospective double-blind randomized controlled trial. Clin Rehabil. 2020 May;34(5):617-629. doi: 10.1177/0269215520912000. Epub 2020 Mar 17.

  PMID: 32183555 BACKGROUND

• Chung S, Jeong YG. Effects of the craniocervical flexion and isometric neck exercise compared in patients with chronic neck pain: A randomized controlled trial. Physiother Theory Pract. 2018 Dec;34(12):916-925. doi: 10.1080/09593985.2018.1430876. Epub 2018 Jan 24.

  PMID: 29364754 BACKGROUND

• Noormohammadpour P, Tayyebi F, Mansournia MA, Sharafi E, Kordi R. A concise rehabilitation protocol for sub-acute and chronic non-specific neck pain. J Bodyw Mov Ther. 2017 Jul;21(3):472-480. doi: 10.1016/j.jbmt.2016.07.005. Epub 2016 Jul 25.

  PMID: 28750953 BACKGROUND

• Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother. 2010 Jul;1(2):100-7. doi: 10.4103/0976-500X.72352. No abstract available.

  PMID: 21350618 BACKGROUND

• Liang L, Feng M, Cui X, Zhou S, Yin X, Wang X, Yang M, Liu C, Xie R, Zhu L, Yu J, Wei X. The effect of exercise on cervical radiculopathy: A systematic review and meta-analysis. Medicine (Baltimore). 2019 Nov;98(45):e17733. doi: 10.1097/MD.0000000000017733.

  PMID: 31702624 BACKGROUND

• Plener J, Ammendolia C, Hogg-Johnson S. Nonoperative management of degenerative cervical radiculopathy: protocol of a systematic review. J Can Chiropr Assoc. 2022 Apr;66(1):74-84.

  PMID: 35655692 BACKGROUND

• Iyer S, Kim HJ. Cervical radiculopathy. Curr Rev Musculoskelet Med. 2016 Sep;9(3):272-80. doi: 10.1007/s12178-016-9349-4.

  PMID: 27250042 BACKGROUND

• Bogduk N. The anatomy and pathophysiology of neck pain. Phys Med Rehabil Clin N Am. 2011 Aug;22(3):367-82, vii. doi: 10.1016/j.pmr.2011.03.008.

  PMID: 21824580 BACKGROUND

• Mansfield M, Smith T, Spahr N, Thacker M. Cervical spine radiculopathy epidemiology: A systematic review. Musculoskeletal Care. 2020 Dec;18(4):555-567. doi: 10.1002/msc.1498. Epub 2020 Jul 25.

  PMID: 32710604 BACKGROUND

• Woods BI, Hilibrand AS. Cervical radiculopathy: epidemiology, etiology, diagnosis, and treatment. J Spinal Disord Tech. 2015 Jun;28(5):E251-9. doi: 10.1097/BSD.0000000000000284.

  PMID: 25985461 BACKGROUND

MeSH Terms

Conditions

Radiculopathy; Neck Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

BANU GOKCEN BAYDOGAN TAN, MEDICAL DOCTOR

CONTACT

+90095058174097; baydogan.g@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, participant and care provider blinding was not feasible. Outcome assessments were performed by a blinded assessor who was unaware of group allocation. The statistician performing the analysis was also blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doktor

Model Details: Participants will be randomly assigned in a 1:1 ratio to two parallel groups: cervical interlaminar epidural steroid injection alone (control group) or cervical interlaminar epidural steroid injection followed by an eight-week standardized home-based exercise program (intervention group).

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: April 2, 2026
• Study Start: February 1, 2026
• Primary Completion: May 1, 2026
• Study Completion: June 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)