Which treatment for low back pain? A factorial randomised controlled trial comparing intravenous analgesics with oral analgesics in the emergency department and a centrally acting muscle relaxant with placebo over three days

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 230

Inclusion Criteria

1. Lower back pain localised between 12th rib and gluteal fold
2. Duration of pain of the current period less than seven days
3. Attending the Department of Emergency Medicine at the Vienna General Hospital because of low back pain
4. Agree to be randomised or agree to be included in the patient preference trial
5. Written informed consent

Exclusion Criteria

1. History:
1.1. Ingestion of any analgesic drug within 6 hours
1.2. Direct impact trauma
1.3. History of cancer
1.4. Unexplained weight loss (greater than 10 kg within three months)
1.5. Current injection drug use
1.6. Any known chronic infection, such as hepatitis, human immunodeficiency virus (HIV), tuberculosis
1.7. Immunosuppressive therapy (such as systemic corticosteroids, ciclosporine, or such)
1.8. Organ transplantation
1.9. History of inflammatory arthritis of large joints
1.10. Current bowel or bladder dysfunction
1.11. Involved in litigation
1.12. Alcohol abuse
1.13. Aged less than 19 and greater than 65 years
1.14. Current abdominal problems (epigastric pain)
1.15. A history of gastric or duodenal ulcer
1.16. A history of severe renal or hepatic insufficiency or severe coronary insufficiency
1.17. Allergies against any non-steroidal analgesics (NSA) or tizanidin
2. Physical examination:
2.1. Fever greater than 38°C
2.2. Sensory or motor deficit in lower limb
2.3. Lasegue positive greater than 60°
2.4. Pregnancy: to be ruled out by a commercially available and routinely used urine pregnancy test
2.5. Urinary tact infection: to be ruled out by a commercially available and routinely used urine dip stick test; infection is assumed if nitrite and leukocytes test positive
3. Communication problems:
3.1. Patients who appear not to be able to understand the information provided to give informed consent for participation in this trial because of mental or physical handicaps. It is the duty of the enrolling physician to decide whether a potential participant has sufficient language skills to understand the information provided or to communicate that she/he understands.
3.2. Patients who appear not to be able to understand the information provided to give informed consent for participation in this trial because of language barriers. Those who need an interpreter to communicate with the treating physician are certainly ineligible. Otherwise it is the duty of the enrolling physician to decide whether a potential participant has sufficient language skills to understand the information provided.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain assessed by means of the VAS. For stage one, the VAS is evaluated immediately before and 90 minutes after treatment, for stage two, the VAS is evaluated on day four.

Secondary Outcome Measures

Name	Time	Method
1. The Roland Morris disability questionnaire (RMDQ)<br>2. 36-item short form health survey (SF-36)<br><br>Stage one is evaluated immediately before treatment by personal interview, then, for stage two, the RMDQ and the SF-36 is evaluated four days after enrolment. Patients will be interviewed by telephone using the structured format of the questionnaires of RMDQ and SF-36.