Contact information
Type
Scientific
Primary contact
Prof Bart W Koes
ORCID ID
Contact details
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
+31 (0)10 4087620
b.koes@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
LRS trial
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.
Ethics approval
Added 19/08/09: Received from Erasmus Medical Centre Ethics Committee
Study design
Randomised open label active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
Lumbosacral Radicular Syndrome also called sciatica
Intervention
Physical therapy added to general practitioners management compared to general practitioners management only.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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 measures
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.
Overall trial start date
01/05/2003
Overall trial end date
01/11/2004
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Added 22/04/2008: 135 patients randomised
Participant 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)
Recruitment start date
01/05/2003
Recruitment end date
01/11/2004
Locations
Countries of recruitment
Netherlands
Trial participating centre
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (Netherlands)
Sponsor details
Department of General Practice
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
+31 (0)10 408 7620
b.koes@erasmusmc.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Dutch Health Care Insurance Board (College voor Zorgverzekeringen) (Netherlands)
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
Basic results (scientific)
Publication list
2004 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15535882
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17700438
Publication citations
-
Results
Luijsterburg PA, Lamers LM, Verhagen AP, Ostelo RW, van den Hoogen HJ, Peul WC, Avezaat CJ, Koes BW, Cost-effectiveness of physical therapy and general practitioner care for sciatica., Spine, 2007, 32, 18, 1942-1948, doi: 10.1097/BRS.0b013e31813162f9.
-
Luijsterburg PA, Verhagen AP, Ostelo RW, van den Hoogen HJ, Peul WC, Avezaat CJ, Koes BW, Conservative treatment in patients with an acute lumbosacral radicular syndrome: design of a randomised clinical trial [ISRCTN68857256]., BMC Musculoskelet Disord, 2004, 5, 1, 39, doi: 10.1186/1471-2474-5-39.