Contact information
Type
Scientific
Primary contact
Dr A. Spijker-Huiges
ORCID ID
Contact details
P.O. Box 196
Groningen
9700 AD
Netherlands
+31 (0)50 363 7232
a.spijker-huiges@med.umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1705; NTR342
Study information
Scientific title
Segmental epidural steroid injections for lumbosacral radicular syndrome: a randomised controlled trial comparing cost-effectiveness of a segmental epidural injection with usual care for patients with lumbosacral radicular syndrome (LRS) in general practice
Acronym
SLURP
Study hypothesis
Adding segmental steroid injections to usual care in the treatment of acute lumbosacral radicular syndrome will reduce pain and fasten recovery in general practice.
Ethics approval
Received from the local medical ethics committee
Study design
Randomised, single-blind, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Lumbosacral Radicular Syndrome
Intervention
1. Intervention group: care as usual, combined with one or two segmental epidural corticosteroid injections (80 mg kenacort)
2. Control group: care as usual
Intervention type
Drug
Phase
Not Specified
Drug names
Kenacort
Primary outcome measures
1. Pain in back and/or leg, while walking, standing, lying down and night pain using a numerical rating scale (NRS) (0 - 10)
2. Severity of main complaint NRS (0 - 10)
3. Perceived recovery (NRS 0 - 10, complete recovery-severe deterioration)
Secondary outcome measures
1. Mobility, which the Roland-Morris Disability Questionnaire
2. Quality of life, measured with thr 36-item short form health survey (SF-36)
3. Primary and secondary health care costs
Overall trial start date
01/09/2005
Overall trial end date
01/09/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Answering to the definition of lumbosacral radicular syndrome as described by the Guidelines of the Dutch College of General Practitioners (see introduction). The GP diagnoses the patient on grounds of history and physical examination.
2. Underwent usual medical care for lumbosacral radicular syndrome with insufficient response in one to two weeks of treatment. Inadequate response is, in accordance with the guideline of the Dutch college of general practitioners, left to the agreement of patients and GPs together.
3. Aged between 18 and 60 years old
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Pain that has lasted for more than one month before the patient presents to the GP (we want to include acute patients)
2. Having experienced a previous episode of lumbosacral radicular syndrome in the twelve months before the study
3. Previously having undergone spinal surgery. Previous spinal surgery will have caused adhesions in the patients' vertebrae, making the approach and the application of the epidural injection much more difficult. Chances of complications are a lot higher and the risk of needle misplacing increases.
4. Complaints arising after trauma. Patients who developed lumbosacral radicular syndrome as a result of trauma may have pathology that needs additional diagnostic imaging and treatment other than injections.
5. Maintenance therapy of oral corticosteroids. Apart from possible interference with the study results, patients on maintenance therapy of oral corticosteroids have a higher risk that their symptoms may be caused by osteoporosis which may need additional diagnostic imaging.
6. Oral anticoagulant therapy or bleeding disorders. Treatment with acenocoumarol and/or other anticoagulants increases the risk of bleeding. Since this risk is not as high with platelet aggregation inhibitors, we will not exclude patients on acetylsalicyclic acid or non-steroidal anti-inflammatory drug (NSAID) maintenance therapy.
7. Paresis or cauda equina syndrome. Lower extremity paresis and especially cauda equina syndrome are indications for immediate referral to a neurosurgeon.
8. Morbid obesity: body mass index (BMI) (weight/square length) greater than 35 In these patients, back pain complaints are much more likely to have other causes than lumbosacral radicular syndrome. Besides, administration of SESI is much more difficult in obese patients since the epidural space is harder to find and the needle may be to short. This increases the risk of false-negative results, needle misplacement and complications
9. Inadequate mastering of Dutch language. When patients are unable to communicate with the primary researcher or fill in the questionnaires, it is not possible to assess their progress or receive informed consent.
10. Allergy to corticosteroids
11. Women who are pregnant, have an active pregnancy wish or are lactating
12. Incapacity of will
Recruitment start date
01/09/2005
Recruitment end date
01/09/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
P.O. Box 196
Groningen
9700 AD
Netherlands
Sponsor information
Organisation
University Medical Centre Groningen (UMCG) (The Netherlands)
Sponsor details
Department of General Practice
Hanzeplein 1
Groningen
9713 GZ
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Medical Centre Groningen (UMCG) (The Netherlands) - doelmatigheidsbureau (MTA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary