WithdrawnNot Applicable

Repeated Transforaminal Anesthetic Injections With or Without Glucocorticoid in Patients With Cervical Radiculopathy

Stopped: study lead could not proceed with the study due to changed employer

0Started 2021-06-01

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 su…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

VAS - Visual analog scale

Timeframe: 6 months

Trial details

NCT IDNCT03541681

SponsorRegion Skane

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-07

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