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

Completed

Conditions: umbosacral Radicular Syndrome also called sciatica
Musculoskeletal Diseases
Dorsalgia

Registration Number: ISRCTN68857256

Lead Sponsor: Erasmus Medical Centre (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 135

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

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Added 19/08/09:<br>Global Perceived Effect (GPE) - measured on a 7 points scale ranging from 1 = completely recovered to 7 = vastly worsened<br>

Secondary Outcome Measures

Name	Time	Method
Added 19/08/09:<br>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<br>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)<br>3. Health status - measured by the 36-item short form (SF-36) and the Euroqol (EQ-5D) instrument<br>4. Fear of movement - measured by the Tampa scale for kinesiophobia (TSK)<br>5. Costs will be calculated and include <br>5.1. LRS related sickness absence from work, <br>5.2. Medical consumption (i.e. medication use, additional therapies, visits to health care providers)<br>5.3. Out-of-pocket expenses<br>5.4. Paid help<br>6. Patients' treatment preference - evaluated at baseline and at 4 follow-up measurements.