Neck PainNCT03541681
Repeated Transforaminal Anesthetic Injections With or Without Glucocorticoid in Patients With Cervical Radiculopathy
A study testing Glucocorticoid Injections and Anesthetic Injections in people with Neck Pain and Radiculopathy, Cervical, run by Region Skane.
Trial summary
The main objective is to evaluate pain and muscle strength in the upper extremities after treatment with cervical transforaminal injection of glucocorticoid vs. transforaminal injection of local anesthetic injection in patients with cervical radiculopathy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain, Radiculopathy, Cervical, Cervical Foraminal Stenosis
- What is being tested?
- Glucocorticoid Injections and Anesthetic Injections
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 30 Dec 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
- People >18 years and <65, referred to the department of Neurosurgery in Lund, Sweden for evaluation and treatment of cervical radiculopathy.
- Patients with radiculopathy who after a diagnostic transforaminal injection with 0,5 ml Bupivacain local anesthetics reported a 50% or more reduction of radicular pain according to the visual analogue scale (VAS) (responders).
- Clinical findings and symptoms (i.e. radiculopathy, muscle weakness, sensibility disorder, reflexes) in the upper extremities, correlating to MRI verified nerve root compression on one single level between C4-C7 caused by spondylosis or disc herniation.
- Patients with positive, >50% pain reduction, diagnostic transforaminal injection who choose conservative treatment as first option before surgery.
- Symptoms from dermatome/myotome radiculopathy > 3 months, corresponding to MR-verified foraminal narrowing caused by disc herniation or foraminal stenosis from spondylosis/facet joint hypertrophy.
- Understanding the oral and written consent form in Swedish, and consenting to the study.
- Capable of adhering to the protocol.
Who cannot join
- Fibromyalgia or other general myalgia not suggestive of radicular pain.
- Cervical myelopathy caused by central spinal stenosis.
- Pain caused by stenosis 3 levels or more and/or disk herniation at 3 levels or more or cervical abnormalities (Klippel-Feil, Lytic/Sclerotic lesions, Recent fractures).
- Previously cervical surgery at the same level or trauma caused by neck distortion i.e. whiplash-associated disorder (WAD).
- Peripheral neuropathy caused by systemic disorders (i.e. diabetes, hereditary, idiopathic or ethanol overconsumption).
- Peripheral nerve compression/entrapment distal to the neuro foramina (i.e. Thoracic outlet syndrome, compression between mm. scalenus, carpal tunnel syndrome)
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- Systematic inflammatory diseases involving cervical spine segments and/or spinal cord.
- Neurological motor disorders e.g. ALS and MS.
- Prior medical conditions causing difficulties to participate according to the protocol i.e. stroke, dementia and mental illness.
- Treatment with glucocorticoids injections in the cervical spine within the last 12 months.
- Allergy to glucocorticoid (Dexamethasone) or local anesthetic (Bupivacain).
About this study
Official title: A Trial of Repeated Transforaminal Injections With Local Anesthetics With or Without Glucocorticoid in Patients With Cervical Radiculopathy; A Single-center, Randomized Controlled Trial With Short- and Long Term Follow-up
The main objective is to evaluate pain and muscle strength in the upper extremities after treatment with cervical transforaminal injection of glucocorticoid vs. transforaminal injection of local anesthetic injection in patients with cervical radiculopathy. The investigators hypothesizes that there are correlations between radiculopathy and muscle weakness.
Read the detailed description
Previously published studies have not shown a difference in outcome between cervical transforaminal injections with cortisone or local anesthetic in a short term, 6-week, follow-up after using a series of three injections of cervical transforaminal glucocorticoid vs. local anesthetic. No study available thus far has evaluated and compared the long-term effect of these two treatments (glucocorticoid vs. local anesthetics). The investigators aim is to verify if there are responders and non-responders to this type of steroid injections. 100 patients with MRI-verified nerve root compression caused by spondylosis or disc herniation and a history of radiculopathy with or without neck pain and muscle weakness will be included. The participants will be included if they showed at least 50% pain reduction in visual analogue scale (VAS) within 30 min of a diagnostic nerve root block with local anesthetic only. The participants will be blinded and randomized to each treatment group. Pain, muscle weakness, disability and quality of life will be evaluated. Follow-up will be made at 3 and 6 months.
- Being tested
- Glucocorticoid Injections, Anesthetic Injections
- Keywords
- Epidural Steroid Injections, Cervical Epidural Injections, Transforaminal Epidural Injections, Steroids, Local Anesthetic
- Medical subject headings
- Neck Pain, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucocorticoid InjectionsProcedure or surgery
1 ml Dexamethasone + 0,5 ml Bupivacain
Anesthetic InjectionsProcedure or surgery
0,5 ml Bupivacain
| Study group | Role | What they receive |
|---|---|---|
| Glucocorticoid Injections | Active comparator | A series of three cervical transforaminal local anesthetic (0,5 ml Bupivacain) injections with glucocorticoid (1 ml Dexamethasone) within 3 months. Receives: Procedure: Glucocorticoid Injections; Procedure: Anesthetic Injections |
| Local Anesthetic Injections | Active comparator | A series of three cervical transforaminal local anesthetic (0,5 ml Bupivacain) injections without glucocorticoid (Dexamethasone) within 3 months. Receives: Procedure: Anesthetic Injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS - Visual analog scale
VAS evaluates levels of pain intensity using an 10 point scale (range 0-10), with 0 being classified as "no pain", and 10 "worst imaginable pain".
Measured: 6 months
Secondary outcomes (6)
Muscle strength - ISOmetric Power device
Exploratory Outcome Measures
Measured: 6 months
Muscle strength - Commander Echo (JTECH Medical)
Exploratory Outcome Measures
Measured: 6 months
Neck disability index
Neck disability index (NDI), is a patient self-reported questionnaire which contains 10 items including pain, personal care, lifting, reading, headaches, concertation, work, driving, sleeping and recreation. The patient scores each section from 0 to 5. Zero indicates 'no pain' and five indicates 'worst imaginable pain'. The highest possible score of the test is 50 which means complete absence from activity.
Measured: 6 months
EQ-5D-3L
An questionnaire that measures and value changes in health-related quality of life. The 3-level version of EuroQol five Dimensions Questionnaire (EQ-5D-L3) evaluates mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). The stated value from each dimension converts to a single summary index from 0-1. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.
Measured: 6 months
Odom´s criteria
The Odum´s criteria is a patient self-reported evaluation in outcome after degenerative cervical disc surgery. A four graded scale from Excellent (No complaints referable to cervical disc disease; able to continue daily occupation without impairment) to Poor (No improvement, or worse compared with the condition before the operation).
Measured: 6 months
The European Myelopathy Score (EMS)
The European Myelopathy Score (EMS) measures the severity of cervical myelopathy. The questionnaire has five sections divided into different functional criteria, which do not need a baseline or prior examination. Section A evaluates gait and has five levels from "not walking, need wheelchair" to "good gait, climb stairs". Section B evaluates hand function (four levels,) Section C evaluates proprioception and coordination (three levels), Section D evaluates bladder and bowel function (3 levels) and finally Section E evaluates sensory function (3 levels). The maximum sum score for a normal subject is 18 points.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start1 Jun 2021 (estimated)
- Primary completion7 Jun 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Why it stopped: study lead could not proceed with the study due to changed employer
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 Neck PainStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niklas Marklund, Professor, Study director, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541681
- Sponsor's protocol ID
- Dnr 2017/804
- Status last verified
- Mar 2020
- First submitted
- 13 Apr 2018
- Last updated
- 25 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Brandt C, Eskilsson A, Tomasevic G. Marklund N. Repeated transforaminal injections in patients with cervical radiculopathy: A randomized trial comparing local anesthetic and glucocorticoid injections on pain and muscle strength. ClinicalTrials.gov [Internet] Identifier Dnr 2017/804, 2018.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Repeated Transforaminal Injections With Local Anesthetics With or Without Glucocorticoid in Patients With Cervical Radiculopathy; A Single-center, Randomized Controlled Trial With Short- and Long Term Follow-up
- ClinicalTrials.gov ID
- NCT03541681
- Acronym / sponsor ID
- Dnr 2017/804
- Keywords
- Epidural Steroid Injections, Cervical Epidural Injections, Transforaminal Epidural Injections, Steroids, Local Anesthetic
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study lead could not proceed with the study due to changed employer
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 7 Jun 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 30 May 2018 (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.
The main objective is to evaluate pain and muscle strength in the upper extremities after treatment with cervical transforaminal injection of glucocorticoid vs. transforaminal injection of local anesthetic injection in patients with cervical radiculopathy. The investigators hypothesizes that there are correlations between radiculopathy and muscle weakness.
Detailed description
Previously published studies have not shown a difference in outcome between cervical transforaminal injections with cortisone or local anesthetic in a short term, 6-week, follow-up after using a series of three injections of cervical transforaminal glucocorticoid vs. local anesthetic. No study available thus far has evaluated and compared the long-term effect of these two treatments (glucocorticoid vs. local anesthetics). The investigators aim is to verify if there are responders and non-responders to this type of steroid injections. 100 patients with MRI-verified nerve root compression caused by spondylosis or disc herniation and a history of radiculopathy with or without neck pain and muscle weakness will be included. The participants will be included if they showed at least 50% pain reduction in visual analogue scale (VAS) within 30 min of a diagnostic nerve root block with local anesthetic only. The participants will be blinded and randomized to each treatment group. Pain, muscle weakness, disability and quality of life will be evaluated. Follow-up will be made at 3 and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucocorticoid Injections | Active comparator | Procedure: Glucocorticoid Injections, Procedure: Anesthetic InjectionsA series of three cervical transforaminal local anesthetic (0,5 ml Bupivacain) injections with glucocorticoid (1 ml Dexamethasone) within 3 months. |
| Local Anesthetic Injections | Active comparator | Procedure: Anesthetic InjectionsA series of three cervical transforaminal local anesthetic (0,5 ml Bupivacain) injections without glucocorticoid (Dexamethasone) within 3 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- People >18 years and <65, referred to the department of Neurosurgery in Lund, Sweden for evaluation and treatment of cervical radiculopathy.
- Patients with radiculopathy who after a diagnostic transforaminal injection with 0,5 ml Bupivacain local anesthetics reported a 50% or more reduction of radicular pain according to the visual analogue scale (VAS) (responders).
- Clinical findings and symptoms (i.e. radiculopathy, muscle weakness, sensibility disorder, reflexes) in the upper extremities, correlating to MRI verified nerve root compression on one single level between C4-C7 caused by spondylosis or disc herniation.
- Patients with positive, >50% pain reduction, diagnostic transforaminal injection who choose conservative treatment as first option before surgery.
- Symptoms from dermatome/myotome radiculopathy > 3 months, corresponding to MR-verified foraminal narrowing caused by disc herniation or foraminal stenosis from spondylosis/facet joint hypertrophy.
Key exclusion criteria (11 listed)
- Fibromyalgia or other general myalgia not suggestive of radicular pain.
- Cervical myelopathy caused by central spinal stenosis.
- Pain caused by stenosis 3 levels or more and/or disk herniation at 3 levels or more or cervical abnormalities (Klippel-Feil, Lytic/Sclerotic lesions, Recent fractures).
- Previously cervical surgery at the same level or trauma caused by neck distortion i.e. whiplash-associated disorder (WAD).
- Peripheral neuropathy caused by systemic disorders (i.e. diabetes, hereditary, idiopathic or ethanol overconsumption).
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 |
|---|---|---|
| Glucocorticoid Injections1 ml Dexamethasone + 0,5 ml Bupivacain | Procedure or surgery | Glucocorticoid Injections |
| Anesthetic Injections0,5 ml Bupivacain | Procedure or surgery | Glucocorticoid Injections, Local Anesthetic Injections |
Primary outcome
VAS - Visual analog scale
Time frame: 6 months
VAS evaluates levels of pain intensity using an 10 point scale (range 0-10), with 0 being classified as "no pain", and 10 "worst imaginable pain".
6 secondary outcomes
Muscle strength - ISOmetric Power device
Time frame: 6 months
Muscle strength - Commander Echo (JTECH Medical)
Time frame: 6 months
Neck disability index
Time frame: 6 months
EQ-5D-3L
Time frame: 6 months
Odom´s criteria
Time frame: 6 months
The European Myelopathy Score (EMS)
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Results publicationBrandt C, Eskilsson A, Tomasevic G. Marklund N. Repeated transforaminal injections in patients with cervical radiculopathy: A randomized trial comparing local anesthetic and glucocorticoid injections on pain and muscle strength. ClinicalTrials.gov [Internet] Identifier Dnr 2017/804, 2018.
- Individual participant dataSharing planned: Undecided
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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.
Niklas Marklund, Professor study director
Region Skane
Questions about this trial
What is this clinical trial studying?
A study testing Glucocorticoid Injections and Anesthetic Injections in people with Neck Pain and Radiculopathy, Cervical, run by Region Skane.
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 7 inclusion and 11 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: withdrawn, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
VAS - Visual analog scale (time frame: 6 months). 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 NCT03541681, 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 25 Jun 2025.