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study lead could not proceed with the study due to changed employer
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Local Anesthetic Injections | Active Comparator | A series of three cervical transforaminal local anesthetic (0,5 ml Bupivacain) injections without glucocorticoid (Dexamethasone) within 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucocorticoid Injections | Procedure | 1 ml Dexamethasone + 0,5 ml Bupivacain |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle strength - ISOmetric Power device | Exploratory Outcome Measures | 6 months |
| Muscle strength - Commander Echo (JTECH Medical) | Exploratory Outcome Measures |
| Measure | Description | Time Frame |
|---|---|---|
| The Swedish National Spine Register | 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. | 6 months |
Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niklas Marklund, Professor | Region Skane | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. |
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| Anesthetic Injections |
| Procedure |
0,5 ml Bupivacain |
|
| 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. | 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'. | 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). | 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. | 6 months |
| ID | Term |
|---|---|
| D019547 | Neck Pain |
| D011843 | Radiculopathy |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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