Surgery versus prolonged conservative treatment for sciatica.
Wilco C Peul, Hans C van Houwelingen, Wilbert B van den Hout...
https://pubmed.ncbi.nlm.nih.gov/17538084Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID03924791
Transforaminal Epidural Injection in Acute Sciatica
Led by C.L.A.Vleggeert-Lankamp · Updated on 2023-10-19
142
Participants Needed
2
Research Sites
30 weeks
Total Duration
On this page
Sponsors
C
C.L.A.Vleggeert-Lankamp
Lead Sponsor
S
Spaarne Gasthuis
Collaborating Sponsor
AI-Summary
What this Trial Is About
Sciatica is a painful condition caused by a herniated lumbar disc pressing on a nerve in the leg, often leading to severe discomfort and reduced physical activity. This trial evaluates two treatments for acute sciatica, focusing on reducing leg pain during the initial weeks of conservative care before surgery is considered. The study is designed to find a better therapy to help patients manage pain and maintain activity levels while waiting for possible surgery. Participants will be randomly assigned to one of two treatment groups. One group receives transforaminal epidural injections containing lidocaine combined with methylprednisolone acetate or dexamethasone depending on the injection level. The other group is treated with standard oral pain medication according to general practice guidelines. The study focuses on the first 8 to 16 weeks of conservative treatment, with injections or medications given early in this period. During the study, participants will have their leg and back pain measured at set times using the Numerical Rating Scale, along with assessments of disability, quality of life, and pain-related questionnaires over 21 weeks. MRI scans will evaluate disc herniation and degeneration after treatment. Researchers will also track any complications from injections and collect data on treatment costs and patient-reported outcomes. Overall participation lasts for 21 weeks after randomization.
CONDITIONS
Brief Title
Transforaminal Epidural Injection in Acute Sciatica
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with sciatica by a general practitioner
- Leg pain score of 6 or more on a 10-point scale
- Symptoms lasting at least 3 weeks and no more than 8 weeks
- Adults aged 18 years or older
You will not qualify if you...
- Under 18 years of age
- Condition preventing receipt of transforaminal epidural injection
- Severe scoliosis
- Received transforaminal epidural injection within 6 months before randomization
- Surgery for sciatica at the same level
- Surgery for sciatica at another level within one year before inclusion
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 8 weeks
Participants receive either transforaminal epidural injections or oral pain medication as part of their treatment for acute sciatica.
1 baseline visit and multiple follow-up visits up to 21 weeks
Follow-up
Duration - Up to 21 weeks after randomization
Participants are monitored for pain levels, disability, quality of life, and treatment complications after the treatment period.
Visits at 1, 2, 4, 10, and 21 weeks after randomization
Trial Site Locations
Total: 2 locations
1
Spaarne Gasthuis
Haarlem, Netherlands
Actively Recruiting
2
Spaarne Gasthuis
Hoofddorp, Netherlands
Actively Recruiting
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Research Team
C
Carmen LA Vleggeert-Lankamp, MD Msc Ph.D
E
Eduard JA Verheijen, Bsc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Most important factors for the implementation of shared decision making in sciatica care: ranking among professionals and patients.
Stefanie N Hofstede, Leti van Bodegom-Vos, Manon M Wentink...
https://pubmed.ncbi.nlm.nih.gov/24710328The Value of Short-Term Pain Relief in Predicting the Long-Term Outcome of Lumbar Transforaminal Epidural Steroid Injections.
Holger Joswig, Armin Neff, Christina Ruppert...
https://pubmed.ncbi.nlm.nih.gov/28838872Epidural steroids for lumbosacral radicular syndrome compared to usual care: quality of life and cost utility in general practice.
Antje Spijker-Huiges, Karin Vermeulen, Jan C Winters...
https://pubmed.ncbi.nlm.nih.gov/25448243The tissue origin of low back pain and sciatica: a report of pain response to tissue stimulation during operations on the lumbar spine using local anesthesia.
S D Kuslich, C L Ulstrom, C J Michael
https://pubmed.ncbi.nlm.nih.gov/1826546Inflammatory cytokines in the herniated disc of the lumbar spine.
H Takahashi, T Suguro, Y Okazima...
https://pubmed.ncbi.nlm.nih.gov/8720407Magnetic resonance imaging interpretation in patients with sciatica who are potential candidates for lumbar disc surgery.
Abdelilah El Barzouhi, Carmen L A M Vleggeert-Lankamp, Geert J Lycklama À Nijeholt...
https://pubmed.ncbi.nlm.nih.gov/23874616Diagnostic accuracy of history taking to assess lumbosacral nerve root compression.
Annemieke J H Verwoerd, Wilco C Peul, Sten P Willemsen...
https://pubmed.ncbi.nlm.nih.gov/24325881Reliability of gadolinium-enhanced magnetic resonance imaging findings and their correlation with clinical outcome in patients with sciatica.
Abdelilah el Barzouhi, Carmen L A M Vleggeert-Lankamp, Geert J Lycklama à Nijeholt...
https://pubmed.ncbi.nlm.nih.gov/24561397Influence of low back pain and prognostic value of MRI in sciatica patients in relation to back pain.
Abdelilah el Barzouhi, Carmen L A M Vleggeert-Lankamp, Geert J Lycklama à Nijeholt...
https://pubmed.ncbi.nlm.nih.gov/24637890