SLURP: Steroidinjections in LUmbosacral Radicular Syndrome

ISRCTN ISRCTN54386944
DOI https://doi.org/10.1186/ISRCTN54386944
Secondary identifying numbers 1705; NTR342
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
18/11/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr A. Spijker-Huiges
Scientific

P.O. Box 196
Groningen
9700 AD
Netherlands

Phone +31 (0)50 363 7232
Email a.spijker-huiges@med.umcg.nl

Study information

Study designRandomised, single-blind, active controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleSegmental 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
Study acronymSLURP
Study objectivesAdding 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(s)Received from the local medical ethics committee
Health condition(s) or problem(s) studiedLumbosacral Radicular Syndrome
Intervention1. Intervention group: care as usual, combined with one or two segmental epidural corticosteroid injections (80 mg kenacort)
2. Control group: care as usual
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Kenacort
Primary outcome measure1. 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 measures1. 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 study start date01/09/2005
Completion date01/09/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit60 Years
SexBoth
Target number of participants80
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/09/2005
Date of final enrolment01/09/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

P.O. Box 196
Groningen
9700 AD
Netherlands

Sponsor information

University Medical Centre Groningen (UMCG) (The Netherlands)
Hospital/treatment centre

Department of General Practice
Hanzeplein 1
Groningen
9713 GZ
Netherlands

Website http://www.umcg.nl/azg/nl/
ROR logo "ROR" https://ror.org/03cv38k47

Funders

Funder type

Hospital/treatment centre

University Medical Centre Groningen (UMCG) (The Netherlands) - doelmatigheidsbureau (MTA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan