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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
| Phone | +31 (0)10 4087620 |
|---|---|
| b.koes@erasmusmc.nl |
Study information
| Study design | Randomised open label active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| 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 | 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 study start date | 01/05/2003 |
| Completion date | 01/11/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Added 22/04/2008: 135 patients randomised |
| 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
3000 DR
Netherlands
Sponsor information
Erasmus Medical Centre (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of General Practice
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
| Phone | +31 (0)10 408 7620 |
|---|---|
| b.koes@erasmusmc.nl | |
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Government
Dutch Health Care Insurance Board (College voor Zorgverzekeringen) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 09/11/2004 | Yes | No | |
| Results article | results | 15/08/2007 | Yes | No |
