Back to resultsRepeated Transforaminal Anesthetic Injections With or Without Glucocorticoid in Patients With Cervical Radiculopathy
Primary Purpose
Neck Pain, Radiculopathy, Cervical, Cervical Foraminal Stenosis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Glucocorticoid Injections
Anesthetic Injections
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring Epidural Steroid Injections, Cervical Epidural Injections, Transforaminal Epidural Injections, Steroids, Local Anesthetic
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
- 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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Glucocorticoid Injections
Local Anesthetic Injections
Arm Description
A series of three cervical transforaminal local anesthetic (0,5 ml Bupivacain) injections with glucocorticoid (1 ml Dexamethasone) within 3 months.
A series of three cervical transforaminal local anesthetic (0,5 ml Bupivacain) injections without glucocorticoid (Dexamethasone) within 3 months.
Outcomes
Primary Outcome Measures
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".
Secondary Outcome Measures
Muscle strength - ISOmetric Power device
Exploratory Outcome Measures
Muscle strength - Commander Echo (JTECH Medical)
Exploratory Outcome Measures
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.
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'.
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03541681
Brief Title
Repeated Transforaminal Anesthetic Injections With or Without Glucocorticoid in Patients With Cervical Radiculopathy
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Anticipated)
Primary Completion Date
January 7, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Radiculopathy, Cervical, Cervical Foraminal Stenosis, Cervical Disc Disease
Keywords
Epidural Steroid Injections, Cervical Epidural Injections, Transforaminal Epidural Injections, Steroids, Local Anesthetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Glucocorticoid Injections
Arm Type
Active Comparator
Arm Description
A series of three cervical transforaminal local anesthetic (0,5 ml Bupivacain) injections with glucocorticoid (1 ml Dexamethasone) within 3 months.
Arm Title
Local Anesthetic Injections
Arm Type
Active Comparator
Arm Description
A series of three cervical transforaminal local anesthetic (0,5 ml Bupivacain) injections without glucocorticoid (Dexamethasone) within 3 months.
Intervention Type
Procedure
Intervention Name(s)
Glucocorticoid Injections
Intervention Description
1 ml Dexamethasone + 0,5 ml Bupivacain
Intervention Type
Procedure
Intervention Name(s)
Anesthetic Injections
Intervention Description
0,5 ml Bupivacain
Primary Outcome Measure Information:
Title
VAS - Visual analog scale
Description
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".
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Muscle strength - ISOmetric Power device
Description
Exploratory Outcome Measures
Time Frame
6 months
Title
Muscle strength - Commander Echo (JTECH Medical)
Description
Exploratory Outcome Measures
Time Frame
6 months
Title
Neck disability index
Description
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.
Time Frame
6 months
Title
EQ-5D-3L
Description
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'.
Time Frame
6 months
Title
Odom´s criteria
Description
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).
Time Frame
6 months
Title
The European Myelopathy Score (EMS)
Description
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.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
The Swedish National Spine Register
Description
The Swedish National Spine Register is a patient-based questionnaire. The form contains participants characteristics generic data, VAS, NDI, EMS and EQ-5D and evaluates pre- and postoperative satisfaction with outcome and ability to work.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria:
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.
Exclusion Criteria:
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)
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Niklas Marklund, Professor
Phone
+46725950261
Email
niklas.marklund@med.lu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Brandt, MD
Email
christian.brandt@med.lu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niklas Marklund, Professor
Organizational Affiliation
Region Skane
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
Citation
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.
Results Reference
result
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Repeated Transforaminal Anesthetic Injections With or Without Glucocorticoid in Patients With Cervical Radiculopathy
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