AzTrials
AzTrials

Cervical RadiculopathyCESI-HEPNCT07506785

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

A study testing Cervical Interlaminar Epidural Steroid Injection and Home-Based Exercise Program in people with Cervical Radiculopathy and Home Based Rehabilitation, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Cervical Interlaminar Epidural Steroid Injection and Home-Based Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2026to Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

BANU GOKCEN BAYDOGAN TAN, MEDICAL DOCTOR contact

+90095058174097

baydogan.g@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Necmettin Erbakan University

    Konya, Turkey, 045

    BANU Gokcen BAYDOGAN TAN, Medical Doctor, 095058174097, baydogan.g@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Cervical Interlaminar Epidural Steroid Injection, Home-Based Exercise Program
Keywords
Cervical Epidural Steroid Injection, Neck Pain, cervical radiculopathy, Home based exercise
Medical subject headings
Radiculopathy, Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cervical Interlaminar Epidural Steroid InjectionProcedure or surgery

    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 ProgramBehavioural

    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.

Study groups in NCT07506785
Study groupRoleWhat they receive
C-ILESI OnlyActive comparatorParticipants receive fluoroscopy-guided cervical interlaminar epidural steroid injection and standardized general advice without a structured exercise program.
Receives: Procedure: Cervical Interlaminar Epidural Steroid Injection
C-ILESI + Home Exercise ProgramExperimentalParticipants receive fluoroscopy-guided cervical interlaminar epidural steroid injection followed by an eight-week standardized home-based exercise program in addition to general advice.
Receives: Procedure: Cervical Interlaminar Epidural Steroid Injection; Behavioral: Home-Based Exercise Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: The NDI was administered at baseline and at weeks 4, 8, and 12.

Secondary outcomes (4)
  1. Numeric Rating Scale (NRS)

    Pain intensity was assessed using a NRS for neck and arm pain, where 0 indicated "no pain" and 10 indicated "worst imaginable pain."

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

  2. Pittsburgh Sleep Quality Index (PSQI)

    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.

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

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

    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.

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

  4. EuroQol Visual Analogue Scale (EQ-VAS)

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2026
  2. Study start1 Feb 2026
  3. Primary completionMay 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07506785
Sponsor's protocol ID
CESI-HEP-RCT-2026
Other IDs
Approval No: 2026-6375
Acronym
CESI-HEP
Status last verified
Mar 2026
First submitted
14 Mar 2026
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data collected in this study will not be publicly shared due to institutional data protection policies and ethical considerations regarding patient confidentiality.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 35655692
  • Iyer S, Kim HJ. Cervical radiculopathy. Curr Rev Musculoskelet Med. 2016 Sep;9(3):272-80. doi: 10.1007/s12178-016-9349-4.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 25985461

Questions about this trial

What is this clinical trial studying?

A study testing Cervical Interlaminar Epidural Steroid Injection and Home-Based Exercise Program in people with Cervical Radiculopathy and Home Based Rehabilitation, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BANU GOKCEN BAYDOGAN TAN, MEDICAL DOCTOR (+90095058174097, baydogan.g@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neck Disability Index (NDI) (time frame: The NDI was administered at baseline and at weeks 4, 8, and 12.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07506785, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in