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Transforaminal Epidural Injection in Acute Sciatica

ConditionsSciaticaSciatica Due to Intervertebral Disc DisorderSciatic Radiculopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorC.L.A.Vleggeert-Lankamp

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age under 18 years

Condition preventing to receive transforaminal epidural injection

Severe scoliosis

Transforaminal epidural injection received in 6 months before randomization date

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lidocaine

    Drug

    In combination with dexamethasone or methylprednisolone acetate

  • Methylprednisolone Acetate

    Drug

    In combination with lidocaine

  • Dexamethasone

    Drug

    In combination with lidocaine

Treatment groups

142 Participants
are divided into 2 treatment groups
Group A: Transforaminal Epidural InjectionExperimental treatment 3 interventions
Group B: Oral pain medicationNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Numerical Rating Scale (NRS) for leg pain

Pain intensity in the leg using the NRS. 0 is the minimal score indicating no pain, 10 is the maximum indicating the worst imaginable pain. Scale increases with increments of 1.

Time frame
2 weeks after randomization

Secondary outcomes

1

Numerical Rating Scale (NRS) for leg pain

Pain intensity in the leg using the NRS. 0 is the minimal score indicating no pain, 10 is the maximum indicating the worst imaginable pain. Scale increases with increments of 1.

Time frame
Baseline, 1, 4, 10 and 21 weeks after randomization
2

Numerical Rating Scale (NRS) for back pain

Pain intensity in the back using the NRS. 0 is the minimal score indicating no pain, 10 is the maximum indicating the worst imaginable pain. Scale increases with increments of 1.

Time frame
Baseline, 1, 2, 4, 10 and 21 weeks after randomization
3

Oswestry Disability Index (ODI)

Assessment of functionality using the ODI. 0 is the minimal score indicating no disability, 50 is the maximum indicating the worst disability possible. This questionnaire is based on 10 questions with answers corresponding to values of 0-5 points.

Time frame
Baseline, 1, 2, 4, 10 and 21 weeks after randomization
4

EuroQoL Cost Utility (EQ-5D)

Assessment of cost utility using the EuroQoL EQ-5D analysis tool. The tool measures five dimensions: mobility, self-care, daily activities, pain/discomfort and anxiety/depression.

Time frame
Baseline, 2, 10 and 21 weeks after randomization

Other outcomes

Sponsors and contacts

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C.L.A.Vleggeert-Lankamp

Lead sponsor

Leiden University Medical Center

Sponsor institution

Spaarne Gasthuis

Collaborator

Stichting Achmea Gezondheidszor

Collaborator

Posthumus Meyjes Fonds

Collaborator

Source ClinicalTrials.gov
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