Condition category
Musculoskeletal Diseases
Date applied
01/11/2004
Date assigned
01/11/2004
Last edited
19/08/2009
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

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 measures

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

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

Results - basic reporting

Publication summary

2004 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15535882
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17700438

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes