SLURP: Steroidinjections in LUmbosacral Radicular Syndrome
| ISRCTN | ISRCTN54386944 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54386944 |
| Protocol serial number | 1705; NTR342 |
| Sponsor | University Medical Centre Groningen (UMCG) (The Netherlands) |
| Funder | University Medical Centre Groningen (UMCG) (The Netherlands) - doelmatigheidsbureau (MTA) |
- 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
Scientific
P.O. Box 196
Groningen
9700 AD
Netherlands
| Phone | +31 (0)50 363 7232 |
|---|---|
| a.spijker-huiges@med.umcg.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, single-blind, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Study acronym | SLURP |
| Study objectives | 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(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Kenacort |
| Primary outcome measure(s) |
1. Pain in back and/or leg, while walking, standing, lying down and night pain using a numerical rating scale (NRS) (0 - 10) |
| Key secondary outcome measure(s) |
1. Mobility, which the Roland-Morris Disability Questionnaire |
| Completion date | 01/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 01/09/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
P.O. Box 196
Groningen
9700 AD
Netherlands
9700 AD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
