Condition category
Musculoskeletal Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
18/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.umcg.nl/azg/nl/

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

Publication citations

Additional files

Editorial Notes