Pain, NeckNCT05307211
Are Stabilization Exercises Effective After Epidural Steroid Injection in Patients With Cervical Radiculopathy?
A study testing Cervical Interlaminar Epidural Steroid Injection, Neck Stabilization Exercises and Neck and Scapular Stabilization Exercises in people with Pain, Neck and Cervical Radiculopathy, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Cervical radiculopathy was first described in 1943 by researchers named Semmes and Murphy, years later than lumbosacral radiculopathy. It is a neurological condition caused by dysfunction in the cervical spinal nerves, nerve roots, or both. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Neck, Cervical Radiculopathy, Pain, Radiating
- What is being tested?
- Cervical Interlaminar Epidural Steroid Injection, Neck Stabilization Exercises and Neck and Scapular Stabilization Exercises
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Mar 2022to 29 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18-65
- Cervical radiculopathy has caused neck and arm pain for at least three months.
- Sign a consent form and volunteer to take part in the study.
Who cannot join
- Previous surgical/interventional procedure for the cervical region
- Presence of other musculoskeletal disorders (such as lateral epicondylitis, tendinitis, entrapment neuropathy) that may cause diagnostic confusion in terms of pain pattern and localization
- Signs of trauma, fracture, malignancy, or active infection
- Rheumatological (RA, AS, etc.), endocrinological (such as osteoporosis, Paget's disease), or another systemic disease that may change the anatomical or physiological structure of the relevant regions Presence of coagulopathy
- History of whiplash injury, cervical spinal stenosis, cervical spondylosis
- Being pregnant and breastfeeding
Show all 10Show fewer
- Presence of mental deterioration or psychiatric/neurological disease that can affect the flow of the study.
- Having a history of allergic reactions to the injectables that will be used.
- Presence of cardiopulmonary disease that may lead to exercise intolerance (heart failure, chronic obstructive pulmonary disease, etc.)
- Failure to implement the exercise program regularly.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University, Faculty of Medicine
Istanbul, Pendik, 34890
About this study
Official title: Evaluation of the Effect of Stabilization Exercises on Interlaminar Epidural Steroid Injection Treatment Results in Cervical Radiculopathy
Cervical radiculopathy was first described in 1943 by researchers named Semmes and Murphy, years later than lumbosacral radiculopathy. It is a neurological condition caused by dysfunction in the cervical spinal nerves, nerve roots, or both. This compression occurs as a result of disc herniation, spondylosis, trauma, spinal tumors, etc. As the first symptom, it manifests as pain. When pain radiates from the neck to the shoulder and arm and is accompanied by sensory complaints and motor weakness, cervical radiculopathy should be suspected. It is a significant cause of morbidity and disability in both men and women, and it occurs in middle age. As a result, clinicians must quickly diagnose and determine the best treatment method. The majority of the information in the literature on the incidence of cervical radiculopathy is based on the findings of a large population-based study conducted between 1976 and 1990 by the Mayo Clinic in Rochester, Minnesota. The incidence rate of cervical radiculopathy was reported to be 83.2 per 100,000 per year in this study, which included 561 cases. The primary goals of treatment are to alleviate pain, restore neurological function, and prevent a recurrence. According to the literature, cervical radiculopathy recurs at a rate of 31.7%, and 26% of them go to surgery. Treatment options vary depending on whether the symptoms are acute or chronic and their severity. In the treatment of cervical radiculopathy, either conservative (non-operative) or surgical treatments are used. In patients with chronic neck pain with or without radiculopathy, a cervical epidural steroid injection is one of the most frequently used interventional therapeutic options. Chronic neck pain or radicular pain caused by disc herniation, spinal stenosis, or discogenic pain can also be treated with cervical epidural injections. Cervical stability training is an exercise program that is used to strengthen the cervical spine, relieve pain, and improve functionality. Changes in dynamic scapula stabilization are observed in patients with chronic neck pain. The scapula connects the neck and shoulder, so it plays an important role in stabilizing the neck and shoulder complex. Because of the interaction between the neck and the scapula, scapular stability becomes more important in these patients.
Read the detailed description
Many studies in the literature separately investigate the effectiveness of Cervical Interlaminar Epidural Steroid Injection (CIESI) in radiculopathy due to cervical disc herniation or the effectiveness of stabilization exercises and physical therapy modalities in these patients. However, there have been no studies on the effectiveness of post-injection exercise training as far as we are aware. Our study aims to investigate the benefit of stabilization exercises after interlaminar epidural steroid injection in patients with radiculopathy caused by cervical disc herniation, add a new study to the literature, and guide future research.
- Conditions
- Pain, Neck, Cervical Radiculopathy, Pain, Radiating
- Being tested
- Cervical Interlaminar Epidural Steroid Injection, Neck Stabilization Exercises, Neck and Scapular Stabilization Exercises
- Keywords
- Pain, cervical radiculopathy, cervical interlaminar epidural steroid injection, stabilization exercises
- Medical subject headings
- Neck Pain, Radiculopathy, 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 will be administered to patients with chronic neck pain due to cervical disc herniation. The injection area is cleaned 3 times with an antiseptic solution and covered with a sterile cloth. Local anesthesia with 2 ccs 3% prilocaine will be applied to the skin and subcutaneous tissues in the area of interest. Under fluoroscopy guidance, the needle is advanced into the C7-T1 intervertebral disc level. With the help of the loss of resistance technique, it is understood that the needle is in the epidural space, and second control is provided by administering contrast material. After the confirmation of needle place is done, a mixture of 12 mg dexamethasone, 1 cc 2% lidocaine, 1 cc saline is injected. The patient is taken to the restroom after the procedure and followed up for any complications.
Neck Stabilization ExercisesOther
The physiotherapist will design an exercise protocol for neck stabilization. Each exercise will be applied three days a week throughout a 4-week program, accompanied by a physiotherapist, and will begin with 7 to 10 repetitions at first, increasing to 10 to 15 repetitions in the following weeks, taking into account the patient's condition. After the physiotherapist-assisted exercises are completed, the protocol will continue as home-based exercises until the assessments are completed.
Neck and Scapular Stabilization ExercisesOther
The physiotherapist will design an exercise protocol for neck and scapular stabilization. Each exercise will be applied three days a week throughout a 4-week program, accompanied by a physiotherapist, and will begin with 7 to 10 repetitions at first, increasing to 10 to 15 repetitions in the following weeks, taking into account the patient's condition. After the physiotherapist-assisted exercises are completed, the protocol will continue as home-based exercises until the assessments are completed.
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1 (CIESI Only) | Active comparator | Only interlaminar epidural steroid injection will be administered to patients in this arm with the same method as in the other arms (one session, week 0). Staying active will be the only recommendation, and no exercise prescription will be provided. Receives: Procedure: Cervical Interlaminar Epidural Steroid Injection |
| GROUP 2 (CIESI plus NECK STABILIZATION EXERCISES) | Experimental | After the interlaminar epidural steroid injection, the patients will be taken to an exercise program in the physical therapy unit, in the company of a physiotherapist, within 24 hours, within 72 hours at the latest. Receives: Procedure: Cervical Interlaminar Epidural Steroid Injection; Other: Neck Stabilization Exercises |
| GROUP 3 ( CIESI plus NECK and SCAPULAR STABILIZATION EXERCISES) | Experimental | After the interlaminar epidural steroid injection, the patients will be taken to an exercise program in the physical therapy unit, in the company of a physiotherapist, within 24 hours, within 72 hours at the latest. Receives: Procedure: Cervical Interlaminar Epidural Steroid Injection; Other: Neck and Scapular Stabilization Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of pain severity from baseline to each checkpoints
The numerical rating scale (NRS) is widely used in research and clinical settings to represent pain intensity. NRS is defined as 0 for the absence of pain and 10 as the worst possible pain. The NRS is moderately reliable and has a clinically important difference (CID) value of 1.0.
Measured: from pre-interventional time to post-interventional 1st hour, 1st month, 3rd month
Secondary outcomes (2)
Change of functionality from baseline to each checkpoints
The Neck Disability Index (NDI) is a validated 10-item questionnaire that measures a patient's self-reported disability due to neck pain. The score ranges from 0 (no disability) to 100 (completely disabled). The minimum detectable change (MDC) for patients with cervical radiculopathy is 10 points, and the clinically important difference (CID) is 14 points.
Measured: from pre-interventional time to post-interventional 1st month, 3rd month
Change of life quality from baseline to each checkpoints
Short Form-12 (SF-12) is a scale that was developed in 1994 to evaluate the quality of life for the last four weeks without focusing on a specific age and disease group. It consists of 12 questions, all selected from the SF-36 Health Questionnaire. SF-12 consists of physical functionality, physical role, pain, general health, emotional role, mental health, social functionality, and vitality sub-components.
Measured: from pre-interventional time to post-interventional 1st month, 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start23 Mar 2022
- Primary completion6 Jan 2023
- Study completion29 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, NeckStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Savaş Şencan, MD, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307211
- Sponsor's protocol ID
- 04.03.2022.357
- Status last verified
- May 2023
- First submitted
- 22 Mar 2022
- Last updated
- 18 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tayboga UI, Olgun Y, Gunduz OH, Sencan S. Are Stabilisation Exercises Effective After Epidural Steroid Injection in Patients With Cervical Radiculopathy? A Prospective Randomised Controlled Trial. Eur J Pain. 2025 Feb;29(2):e4777. doi: 10.1002/ejp.4777.
PubMed 39779455
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Stabilization Exercises on Interlaminar Epidural Steroid Injection Treatment Results in Cervical Radiculopathy
- ClinicalTrials.gov ID
- NCT05307211
- Acronym / sponsor ID
- 04.03.2022.357
- Conditions
- Pain, Neck, Cervical Radiculopathy, Pain, Radiating
- Keywords
- Pain, cervical radiculopathy, cervical interlaminar epidural steroid injection, stabilization exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 29 Apr 2023 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cervical radiculopathy was first described in 1943 by researchers named Semmes and Murphy, years later than lumbosacral radiculopathy. It is a neurological condition caused by dysfunction in the cervical spinal nerves, nerve roots, or both. This compression occurs as a result of disc herniation, spondylosis, trauma, spinal tumors, etc. As the first symptom, it manifests as pain. When pain radiates from the neck to the shoulder and arm and is accompanied by sensory complaints and motor weakness, cervical radiculopathy should be suspected. It is a significant cause of morbidity and disability in both men and women, and it occurs in middle age. As a result, clinicians must quickly diagnose and determine the best treatment method. The majority of the information in the literature on the incidence of cervical radiculopathy is based on the findings of a large population-based study conducted between 1976 and 1990 by the Mayo Clinic in Rochester, Minnesota. The incidence rate of cervical radiculopathy was reported to be 83.2 per 100,000 per year in this study, which included 561 cases. The primary goals of treatment are to alleviate pain, restore neurological function, and prevent a recurrence. According to the literature, cervical radiculopathy recurs at a rate of 31.7%, and 26% of them go to surgery. Treatment options vary depending on whether the symptoms are acute or chronic and their severity. In the treatment of cervical radiculopathy, either conservative (non-operative) or surgical treatments are used. In patients with chronic neck pain with or without radiculopathy, a cervical epidural steroid injection is one of the most frequently used interventional therapeutic options. Chronic neck pain or radicular pain caused by disc herniation, spinal stenosis, or discogenic pain can also be treated with cervical epidural injections. Cervical stability training is an exercise program that is used to strengthen the cervical spine, relieve pain, and improve functionality. Changes in dynamic scapula stabilization are observed in patients with chronic neck pain. The scapula connects the neck and shoulder, so it plays an important role in stabilizing the neck and shoulder complex. Because of the interaction between the neck and the scapula, scapular stability becomes more important in these patients.
Detailed description
Many studies in the literature separately investigate the effectiveness of Cervical Interlaminar Epidural Steroid Injection (CIESI) in radiculopathy due to cervical disc herniation or the effectiveness of stabilization exercises and physical therapy modalities in these patients. However, there have been no studies on the effectiveness of post-injection exercise training as far as we are aware. Our study aims to investigate the benefit of stabilization exercises after interlaminar epidural steroid injection in patients with radiculopathy caused by cervical disc herniation, add a new study to the literature, and guide future research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 (CIESI Only) | Active comparator | Procedure: Cervical Interlaminar Epidural Steroid InjectionOnly interlaminar epidural steroid injection will be administered to patients in this arm with the same method as in the other arms (one session, week 0). Staying active will be the only recommendation, and no exercise prescription will be provided. |
| GROUP 2 (CIESI plus NECK STABILIZATION EXERCISES) | Experimental | Procedure: Cervical Interlaminar Epidural Steroid Injection, Other: Neck Stabilization ExercisesAfter the interlaminar epidural steroid injection, the patients will be taken to an exercise program in the physical therapy unit, in the company of a physiotherapist, within 24 hours, within 72 hours at the latest. |
| GROUP 3 ( CIESI plus NECK and SCAPULAR STABILIZATION EXERCISES) | Experimental | Procedure: Cervical Interlaminar Epidural Steroid Injection, Other: Neck and Scapular Stabilization ExercisesAfter the interlaminar epidural steroid injection, the patients will be taken to an exercise program in the physical therapy unit, in the company of a physiotherapist, within 24 hours, within 72 hours at the latest. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between the ages of 18-65
- Cervical radiculopathy has caused neck and arm pain for at least three months.
- Sign a consent form and volunteer to take part in the study.
Key exclusion criteria (10 listed)
- Previous surgical/interventional procedure for the cervical region
- Presence of other musculoskeletal disorders (such as lateral epicondylitis, tendinitis, entrapment neuropathy) that may cause diagnostic confusion in terms of pain pattern and localization
- Signs of trauma, fracture, malignancy, or active infection
- Rheumatological (RA, AS, etc.), endocrinological (such as osteoporosis, Paget's disease), or another systemic disease that may change the anatomical or physiological structure of the relevant regions Presence of coagulopathy
- History of whiplash injury, cervical spinal stenosis, cervical spondylosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical Interlaminar Epidural Steroid InjectionFluoroscopy-guided cervical interlaminar epidural steroid injection will be administered to patients with chronic neck pain due to cervical disc herniation. The injection area is cleaned 3 times with an antiseptic solution and covered with a sterile cloth. Local anesthesia with 2 ccs 3% prilocaine will be applied to the skin and subcutaneous tissues in the area of interest. Under fluoroscopy guidance, the needle is advanced into the C7-T1 intervertebral disc level. With the help of the loss of resistance technique, it is understood that the needle is in the epidural space, and second control is provided by administering contrast material. After the confirmation of needle place is done, a mixture of 12 mg dexamethasone, 1 cc 2% lidocaine, 1 cc saline is injected. The patient is taken to the restroom after the procedure and followed up for any complications. | Procedure or surgery | GROUP 1 (CIESI Only), GROUP 2 (CIESI plus NECK STABILIZATION EXERCISES), GROUP 3 ( CIESI plus NECK and SCAPULAR STABILIZATION EXERCISES) |
| Neck Stabilization ExercisesThe physiotherapist will design an exercise protocol for neck stabilization. Each exercise will be applied three days a week throughout a 4-week program, accompanied by a physiotherapist, and will begin with 7 to 10 repetitions at first, increasing to 10 to 15 repetitions in the following weeks, taking into account the patient's condition. After the physiotherapist-assisted exercises are completed, the protocol will continue as home-based exercises until the assessments are completed. | Other | GROUP 2 (CIESI plus NECK STABILIZATION EXERCISES) |
| Neck and Scapular Stabilization ExercisesThe physiotherapist will design an exercise protocol for neck and scapular stabilization. Each exercise will be applied three days a week throughout a 4-week program, accompanied by a physiotherapist, and will begin with 7 to 10 repetitions at first, increasing to 10 to 15 repetitions in the following weeks, taking into account the patient's condition. After the physiotherapist-assisted exercises are completed, the protocol will continue as home-based exercises until the assessments are completed. | Other | GROUP 3 ( CIESI plus NECK and SCAPULAR STABILIZATION EXERCISES) |
Primary outcome
Change of pain severity from baseline to each checkpoints
Time frame: from pre-interventional time to post-interventional 1st hour, 1st month, 3rd month
The numerical rating scale (NRS) is widely used in research and clinical settings to represent pain intensity. NRS is defined as 0 for the absence of pain and 10 as the worst possible pain. The NRS is moderately reliable and has a clinically important difference (CID) value of 1.0.
2 secondary outcomes
Change of functionality from baseline to each checkpoints
Time frame: from pre-interventional time to post-interventional 1st month, 3rd month
Change of life quality from baseline to each checkpoints
Time frame: from pre-interventional time to post-interventional 1st month, 3rd month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Derived from this study: PubMed 39779455Tayboga UI, Olgun Y, Gunduz OH, Sencan S. Are Stabilisation Exercises Effective After Epidural Steroid Injection in Patients With Cervical Radiculopathy? A Prospective Randomised Controlled Trial. Eur J Pain. 2025 Feb;29(2):e4777. doi: 10.1002/ejp.4777.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Savaş Şencan, MD principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical Interlaminar Epidural Steroid Injection, Neck Stabilization Exercises and Neck and Scapular Stabilization Exercises in people with Pain, Neck and Cervical Radiculopathy, run by Marmara 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 18 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pain severity from baseline to each checkpoints (time frame: from pre-interventional time to post-interventional 1st hour, 1st month, 3rd month). 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 NCT05307211, which also lists 1 linked publication.
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 18 May 2023.