Transforaminal Epidural Injection in Acute Sciatica

Transforaminal Epidural Injection in Acute Sciatica

Sponsors

Lead sponsor: C.L.A.Vleggeert-Lankamp

Collaborator: Spaarne Gasthuis
Stichting Achmea Gezondheidszor
Posthumus Meyjes Fonds

Source Leiden University Medical Center
Brief Summary

Patients suffering from sciatica are treated conservatively for the first 8 weeks due to the favourable prognosis. This period is preferably extended up to 14-16 weeks after which patients may opt for surgery. However, patients may experience severe discomfort due to pain in the leg which can lead to decreased physical activity and socio-economic problems. An adequate therapy to alleviate symptoms during this period of 'wait-and-see' is lacking. In this study, patients will be randomized to treatment with transforaminal epidural injections or standard oral pain medication.

Detailed Description

Sciatica is a condition of radicular pain in the leg and is usually caused by herniation of a lumbar intervertebral disc. The herniated disc compresses a lumbar nerve root that continues its route into the sciatic nerve. About 13% to 40% of all people will suffer from sciatica at least once during their lifetime. Sciatica can have severe socio-economic effects; patients are immobilised by the pain they experience and therefore cannot go to work or participate in social events. Most cases resolve spontaneously with conservative therapy using only standard analgesics and/or physiotherapy. In a large RCT it was demonstrated that outcome of conservative and surgical therapy was comparable after 26 weeks. With this knowledge the guidelines for surgical treatment of sciatica were adjusted and it is nowadays usual care to offer surgery only after at least 8 weeks of conservative care and preferably after 14-16 weeks of conservative care. This decision is made together with the patient in a process of Shared Decision making. Although this treatment regimen has been demonstrated to be efficacious and cost effective, the burden for a patient during these weeks of conservative care is usually high. The investigators seek to find a type of conservative care to reduce the discomfort due to the pain and to enable the patient to remain physically active. Not only will this add to the quality of life of the patient, but it will also prevent the patient from taking a sick-leave. In this study, patients will be randomized to either treatment with transforaminal epidural injections or to standard care consisting of oral pain medication.

Overall Status Recruiting
Start Date June 1, 2019
Completion Date December 2020
Primary Completion Date December 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Numerical Rating Scale (NRS) for leg pain 2 weeks after randomization
Secondary Outcome
Measure Time Frame
Numerical Rating Scale (NRS) for leg pain Baseline, 1, 4, 10 and 21 weeks after randomization
Numerical Rating Scale (NRS) for back pain Baseline, 1, 2, 4, 10 and 21 weeks after randomization
Oswestry Disability Index (ODI) Baseline, 1, 2, 4, 10 and 21 weeks after randomization
EuroQoL Cost Utility (EQ-5D) Baseline, 2, 10 and 21 weeks after randomization
Quality of Life Visual Analogue Scale Baseline, 2, 10 and 21 weeks after randomization
Likert scale Baseline, 1, 2, 4, 10 and 21 weeks after randomization
Cost diary 10 and 21 weeks after randomization
Complications from treatment with transforaminal epidural injection (TEI) Throughout the follow-up of 21 weeks
Level and shape of disc herniation from MRI data 21 weeks after randomization
Size of disc herniation from MRI data 21 weeks after randomization
Pfirrmann scale for disc degeneration on MRI 21 weeks after randomization
Histology of disc material obtained during surgery 21 weeks after randomization
Modic scale for end plate changes on MRI 21 weeks after randomization
Weishaupt scale for facet degeneration on MRI 21 weeks after randomization
Enrollment 142
Condition
Intervention

Intervention type: Drug

Intervention name: Lidocaine

Description: In combination with dexamethasone or methylprednisolone acetate

Arm group label: Transforaminal Epidural Injection

Intervention type: Drug

Intervention name: Methylprednisolone Acetate

Description: In combination with lidocaine

Arm group label: Transforaminal Epidural Injection

Other name: Depo-Medrol

Intervention type: Drug

Intervention name: Dexamethasone

Description: In combination with lidocaine

Arm group label: Transforaminal Epidural Injection

Eligibility

Criteria:

Inclusion Criteria:

- Diagnosed with sciatica by GP

- NRS leg pain of 6 or more on a 10-point NRS scale

- Minimum duration of symptoms of 3 weeks and maximum duration of 8 weeks

Exclusion Criteria:

- Age under 18 years

- Condition preventing to receive transforaminal epidural injection

- Severe scoliosis

- Transforaminal epidural injection received in 6 months before randomization date

- Surgery for sciatica at the same level

- Surgery for sciatica at another level within one year before inclusion

- Pregnancy

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Carmen LA Vleggeert-Lankamp, MD Msc Ph.D Principal Investigator Leiden University Medical Center
Overall Contact

Last name: Carmen LA Vleggeert-Lankamp, MD Msc Ph.D

Phone: +31715262109

Email: [email protected]

Location
facility status contact
Spaarne Gasthuis | Haarlem, Netherlands Recruiting Carmen Vleggeert-Lankamp, M.D. Ph.D
Spaarne Gasthuis | Hoofddorp, Netherlands Recruiting Carmen Vleggeert-Lankamp, M.D. Ph.D
Location Countries

Netherlands

Verification Date

May 2019

Responsible Party

Responsible party type: Sponsor-Investigator

Investigator affiliation: Leiden University Medical Center

Investigator full name: C.L.A.Vleggeert-Lankamp

Investigator title: Dr. C.L.A. Vleggeert-Lankamp

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Transforaminal Epidural Injection

Arm group type: Experimental

Description: Transforaminal Epidural Injection containing 1,5 mL lidocaine 2% and 40mg methylprednisolone acetate for injections L3 or below Transforaminal Epidural Injection containing 1,5 mL lidocaine 1% and 10mg dexamethasone for injections above L3

Arm group label: Oral pain medication

Arm group type: No Intervention

Description: Patients will receive oral pain medication according to general practitioner guidelines.

Acronym TEIAS
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Patients will be randomized to either treatment with transforaminal epidural injection or standard oral pain medication.

Primary purpose: Treatment

Masking: None (Open Label)

Masking description: Since masking is not possible for treatment with injections and oral pain medication, this is an open-label study. Outcomes are assessed by patients through online questionnaires and therefore the outcome assessor is not masked as well.

Source: ClinicalTrials.gov