adults aged from 18-65 with acute non-specific low back pain
Conditions
Interventions
tramadol arm:encapsulated tramadol plus encapsulated tizanidine like placebo
tizanidine arm:encapsulated tizanidine plus encapsulated tramadol like placebo
placebo arm:encapsulated tramadol like placebo plus encapsulated tizanidine like placebo
Sponsors
Food and Health Bureau, Hong Kong SAR Government
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients aged from 18 to 65 attending the participating EDs from 9am to 4pm on weekdays for non-specific low back pain, as defined by pain between the twelfth rib and the crease of the buttocks. Patients with sciatica and radicular pain will be included, except those of traumatic in-origin (direct trauma to the back) or those with identified red flag signs for significant pathologies. These patients normally are managed by clinicians within the emergency department, and the emergency medicine ward (EMW) if symptoms are severe. We will recruit patients with a score greater than five on the RMDQ, as previous studies have suggested that the minimal clinically important difference to be five. By recruiting this group of patients, we exclude those expected to resolve no matter if or which analgesics are given.
Exclusion criteria
Exclusion criteria: Patients will be excluded if they are non-Chinese in ethnicity, if they present with LBP of more than four weeks in origin or LBP caused by direct trauma. Patients suspected to have conditions other than non-specific acute LBP, including those with red flag signs and symptoms, and those to be admitted to wards other than EMW or those who require operative treatment. Patients who have a RMDQ less than five at baseline, or those who have been given analgesic drugs outside of the protocol in the same ED visit. Pregnant patients, those taking oral contraceptive pills or those who are contraindicated to one or more of the drugs including active gastrointestinal symptoms, renal insufficiency with serum creatinine >150 umol/L, bleeding disorder, on warfarin or other anticoagulants (patients on antiplatelet drugs is not an exclusion criteria, unless deemed unfit by treating clinician), those with known allergy or with significant drug interaction. Those who are not able for follow up, including those without a telephone contact, or with significant co-morbidity which could interfere with assessments, including confusion or dementia will also be excluded. Patients holding a US or Canadian passport will also be excluded following the policy of the clinical trial insurance. Patients will be advised not to receive oral herbal treatment simultaneously, as there maybe potential interaction of the ingredients. If patients wish to continue oral herbal treatment during the trial period, then they will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RMDQ score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale;side effect profile;drug compliance;sick leave period;return to work capacity; | — |
Countries
China
Contacts
Public ContactKevin HUNG Kei-ching
Accident and Emergency Medicine Academic Unit, the Chinese University of Hong Kong
Outcome results
None listed