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

NCT07506785 — Not applicable, Recruiting, 60 participants, Necmettin Erbakan University

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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

RegistryNCT07506785, acronym CESI-HEP
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment60 (Estimated)
SponsorNecmettin Erbakan University (Other)
ConditionsCervical Radiculopathy, Home Based Rehabilitation
InterventionsCervical Interlaminar Epidural Steroid Injection, Home-Based Exercise Program (Procedure, behavioral)
Datesstart 2026-02-01, primary completion 2026-05-01 (estimated), completion 2026-06-01 (estimated), first posted 2026-04-02, last updated 2026-04-02
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Cervical Radiculopathy All trials for Home Based Rehabilitation All trials of Cervical Interlaminar Epidural Steroid Injection All trials of Home-Based Exercise Program

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
C-ILESI OnlyActive comparatorProcedure: Cervical Interlaminar Epidural Steroid InjectionParticipants receive fluoroscopy-guided cervical interlaminar epidural steroid injection and standardized general advice without a structured exercise program.
C-ILESI + Home Exercise ProgramExperimentalProcedure: Cervical Interlaminar Epidural Steroid Injection; Behavioral: Home-Based Exercise ProgramParticipants receive fluoroscopy-guided cervical interlaminar epidural steroid injection followed by an eight-week standardized home-based exercise program in addition to general advice.
  • 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.
  • 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.

+Outcome measures

Primary outcomes

  • Neck Disability Index (NDI) [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.

Secondary outcomes

  • Numeric Rating Scale (NRS) [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."
  • Pittsburgh Sleep Quality Index (PSQI) [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.
  • 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.]: 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.
  • EuroQol Visual Analogue Scale (EQ-VAS) [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.

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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.

+Locations (1)

FacilityCityCountryStatus
Necmettin Erbakan UniversityKonya, TurkeyTurkey (Türkiye)Recruiting

+Publications

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  • 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
  • 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
  • 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