Combination therapy for preventing lumbar disc surgeries

Phase 1

Conditions: umbosacral Radicular Syndrome
MedDRA version: 20.0Level: LLTClassification code 10037739Term: R sciaticaSystem Organ Class: 100000014640
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2017-002119-33-NL

Lead Sponsor: ZonMW

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Incapacitating lumbosacral radicular syndrome with leg pain (with or without back pain) that had lasted for a minimum of 6 weeks
with or without mild neurological deficit (MRC higher than 3)
• MRI which confirms a lumbar HNP that compromises the spinal nerve and can explain the clinical symptoms of the patient
• The patients should according to usual care have an indication for lumbar HNP operation by a neurosurgeon.
• Signed informed consent for participation in the study
• 18 years and
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46

Exclusion Criteria

A potentially eligible subject who meets any of the following criteria will be excluded from participation in this study:
• Patients exclude suffering from cauda equina syndrome
• Previous spine surgery at the same level during the previous 6 months
• Previous transforminal injections at the same level during the previous 6 months
• Bony stenosis
• Spondylolisthesis
• Pregnancy
• Complicated disc herniation requiring more operations
• Severe coexisting disease e.g. osteoporosis, dementia
• Patient with contra-indications for steroids injections
• Insufficient knowledge of the Dutch language
• Emergency surgery as determined by the neurosurgeon
• Severe paresis MRC less than or equal to 3
• Being allergic for OMNIPAQUE 240

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to assess the effectiveness and cost-effectiveness in terms of the number of surgeries prevented of a combination therapy versus usual care.;Secondary Objective: The secondary objective of this study is to assess the effectiveness and cost-effectiveness in terms of pain (leg and back), functioning, self-perceived recovery and health-related quality of life of a combination therapy versus usual care.;Primary end point(s): Surgery rate (number of patients undergoing surgery during a 12-month follow-up) ;Timepoint(s) of evaluation of this end point: Baseline and 2, 4, 6, 9 and 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Back and leg pain intensity (NPRS), physical functioning (RMDQ-23), self-perceived recovery (GPE), health-related quality of life (EQ-5D-5L) en societal costs.;Timepoint(s) of evaluation of this end point: Baseline, 4 weeks (only for pain), and 2, 4, 6, 9 and 12 months