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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Поведенческое 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

Первичные конечные точки

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

Вторичные конечные точки (4)

• Numeric Rating Scale (NRS) [Срок оценки: Pain intensity was recorded at baseline and at weeks 2, 4, 8, and 12.]
• Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: PSQI was administered at baseline and at weeks 4,8 and 12.]
• The EuroQol five-dimension, five-level questionnaire (EQ-5D-5L) [Срок оценки: EQ-5D-5L scores were obtained at baseline, week 4,8 and at week 12.]
• EuroQol Visual Analogue Scale (EQ-VAS) [Срок оценки: The EQ-VAS scores were obtained at baseline, week 4,8 and at week 12.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Necmettin Erbakan University — Konya

Публикации

• 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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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