Conservative treatment in patients with an acute Lumbosacral Radicular Syndrome: design of a randomised clinical trial

ISRCTN	ISRCTN68857256
DOI	https://doi.org/10.1186/ISRCTN68857256
Protocol serial number	N/A
Sponsor	Erasmus Medical Centre (Netherlands)
Funder	Dutch Health Care Insurance Board (College voor Zorgverzekeringen) (Netherlands)

Submission date: 01/11/2004
Registration date: 01/11/2004
Last edited: 19/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Bart W Koes
Scientific

P.O. Box 1738
Rotterdam
3000 DR
Netherlands

Phone	+31 (0)10 4087620
Email	b.koes@erasmusmc.nl

Study information

Primary study design	Interventional
Study design	Randomised open label active controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	LRS trial
Study objectives	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(s)	Added 19/08/09: Received from Erasmus Medical Centre Ethics Committee
Health condition(s) or problem(s) studied	Lumbosacral Radicular Syndrome also called sciatica
Intervention	Physical therapy added to general practitioners management compared to general practitioners management only.
Intervention type	Other
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
Key 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.
Completion date	01/11/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	135
Key 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
Key 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)
Date of first enrolment	01/05/2003
Date of final enrolment	01/11/2004

Locations

Countries of recruitment

Netherlands

Study participating centre

P.O. Box 1738

Rotterdam
3000 DR
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/08/2007		Yes	No
Protocol article	protocol	09/11/2004		Yes	No