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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN68857256
Enrollment
135
Registered
2004-11-01
Start date
2003-05-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbosacral Radicular Syndrome also called sciatica Musculoskeletal Diseases Dorsalgia

Interventions

Physical therapy added to general practitioners management compared to general practitioners management only.

Sponsors

Erasmus Medical Centre (Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
Added 19/08/09: Global Perceived Effect (GPE) - measured on a 7 points scale ranging from 1 = completely recovered to 7 = vastly worsened

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026