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Conservative treatment in patients with an acute Lumbosacral Radicular Syndrome: design of a randomised clinical trial
ISRCTN ISRCTN68857256
DOI 10.1186/ISRCTN68857256
ClinicalTrials.gov identifier
EudraCT number
Public title Conservative treatment in patients with an acute Lumbosacral Radicular Syndrome: design of a randomised clinical trial
Scientific title
Acronym LRS trial
Serial number at source N/A
Study hypothesis Added 19/08/09:
The aim of this study is to determine effectiveness of physical therapy added to general practitioners management compared to general practitioners management only in patients with an acute lumbosacral radicular syndrome (also called sciatica).

As of 19/08/09 this record has been extensively updated. All updates can be found under the relavent field with the above update date.
Lay summary
Ethics approval Added 19/08/09: Received from Erasmus Medical Centre Ethics Committee
Study design Randomised open label active controlled parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Lumbosacral Radicular Syndrome also called sciatica
Participants - inclusion criteria 1. Radiating (pain) complaints in the leg below the knee
2. Severity of complaints scored above 3 on a 10 point Visual Analogue Scale (VAS) (0 = no complaints; 10 = maximum complaints)
3. Duration of the (pain) complaints less than 6 weeks
4. Age above 18 years
5. Able to speak and read Dutch
6. Presents of one of the following symptoms:
6.1. More pain on coughing, sneezing or straining
6.2. Decreased muscle strength in the leg
6.3. Sensory deficits in the leg
6.4. Decreased reflex activity in the leg
6.5. Positive straight leg raising test
Participants - exclusion criteria 1. Radiating (pain) complaints in the preceding 6 months
2. Back surgery in the past 3 years
3. Treated with epidural injections
4. Pregnancy
5. Co-morbidity that primary determines overall well being
6. Direct indication for surgery (unbearable pain, fast progression of paresis or cauda equina syndrome
7. Expected loss to follow-up (i.e. moving towards other part of the country, long lasting foreign holiday)
Anticipated start date 01/05/2003
Anticipated end date 01/11/2004
Status of trial Completed
Patient information material
Target number of participants Added 22/04/2008: 135 patients randomised
Interventions Physical therapy added to general practitioners management compared to general practitioners management only.
Primary outcome measure(s) Added 19/08/09:
Global Perceived Effect (GPE) - measured on a 7 points scale ranging from 1 = completely recovered to 7 = vastly worsened
Secondary outcome measure(s) Added 19/08/09:
1. Pain severity of the leg and the back - scored on a 11 points Visual Analogue Scale (VAS) ranging from 0 = no pain to 10 = unbearable pain
2. Functional status - measured with the Roland Morris Disability Questionnaire (RDQ) for sciatica. The scoring of the RDQ is achieved by counting the number of positive responses: a patient individual score can vary from 0 (no disability) to 24 (severe disability)
3. Health status - measured by the 36-item short form (SF-36) and the Euroqol (EQ-5D) instrument
4. Fear of movement - measured by the Tampa scale for kinesiophobia (TSK)
5. Costs will be calculated and include
5.1. LRS related sickness absence from work,
5.2. Medical consumption (i.e. medication use, additional therapies, visits to health care providers)
5.3. Out-of-pocket expenses
5.4. Paid help
6. Patients' treatment preference - evaluated at baseline and at 4 follow-up measurements.
Sources of funding Dutch Health Care Insurance Board (College voor Zorgverzekeringen) (Netherlands)
Trial website
Publications 2004 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15535882
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17700438
Contact name Prof  Bart W  Koes
  Address P.O. Box 1738
  City/town Rotterdam
  Zip/Postcode 3000 DR
  Country Netherlands
  Tel +31 (0)10 4087620
  Fax +31 (0)10 4089194
  Email b.koes@erasmusmc.nl
Sponsor Erasmus Medical Centre (Netherlands)
  Address Department of General Practice
P.O. Box 1738
  City/town Rotterdam
  Zip/Postcode 3000 DR
  Country Netherlands
  Tel +31 (0)10 408 7620
  Fax +31 (0)10 408 9194
  Email b.koes@erasmusmc.nl
Date applied 01/11/2004
Last edited 19/08/2009
Date ISRCTN assigned 01/11/2004
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