Clinical trial NCT03541681: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Neck Pain
Radiculopathy, Cervical
Cervical Foraminal Stenosis
Cervical Disc Disease
Keywords: Epidural Steroid Injections
Cervical Epidural Injections
Transforaminal Epidural Injections
Steroids
Local Anesthetic
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: VAS - Visual analog scale
timeFrame: 6 months
Secondary outcomes:
measure: Muscle strength - ISOmetric Power device
timeFrame: 6 months
measure: Muscle strength - Commander Echo (JTECH Medical)
timeFrame: 6 months
measure: Neck disability index
timeFrame: 6 months
measure: EQ-5D-3L
timeFrame: 6 months
measure: Odom´s criteria
timeFrame: 6 months
measure: The European Myelopathy Score (EMS)
timeFrame: 6 months
Other outcomes:
measure: The Swedish National Spine Register
timeFrame: 6 months
Locations:
Study officials:
affiliation: Region Skane
name: Niklas Marklund, Professor
role: STUDY_DIRECTOR
References:
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.