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

Official title

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

Overview

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.

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.

Interventions

• 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 pri

Primary outcome measures

• Neck Disability Index (NDI) [Time frame: The NDI was administered at baseline and at weeks 4, 8, and 12.]

Secondary outcome measures (4)

• Numeric Rating Scale (NRS) [Time frame: 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.]
• 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.]
• EuroQol Visual Analogue Scale (EQ-VAS) [Time frame: The EQ-VAS scores were obtained at baseline, week 4,8 and at week 12.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Necmettin Erbakan University — Konya

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07506785 · CESI-HEP-RCT-2026 · Approval No: 2026-6375

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗