SLURP: Steroidinjections in LUmbosacral Radicular Syndrome.
- Conditions
- umbosacral Radicular Syndrome, pain radiating from the back to the leg, to below the knee, due to irritated nerve roots. In most cases, the cause is a protruding low lumbar disc.
- Registration Number
- NL-OMON23550
- Lead Sponsor
- MTA (doelmatigheidsbureau) UMCG.Department of General Practice, University of Groningen.
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 80
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.
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 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: BMI (weight/square length) > 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Pain in back and/or leg, while walking, standing, lying down and night pain using a numerical rating scale (NRS) (0-10);<br>2. Severity of main complaint NRS (0-10);<br>3. Perceived recovery (NRS 0-10, complete recovery-severe deterioration).
- Secondary Outcome Measures
Name Time Method 1. Mobility, which the Roland-Morris disability questionnaire;<br>2. Quality of life, measured with SF36;<br>3. Primary and secondary health care costs.