benign low back pain
Conditions
Interventions
1. Wash-out of pain medication in one week
2. Study starts with measures T1.
3. Than treatment starts which consists of paracetamol/tramadol 325 mg/37.5 mg
per capsule, or placebo. The dose will be
tramadol 225 mg
placebo in an identical way (maximally three times
two capsules a day).
4.Two weeks after start medication, measures T2 take place.
5.After that medication (analgesic or placebo) will stop.
Contro
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Non-specific low back pain with a VAS score >= 40mm, pain lasting longer than 3 months, age older than 18 years, and motivated for multidisciplinary rehabilitation. Patients are informed about the study and have signed informed consent form.
Exclusion criteria
Exclusion criteria: Mental (for example major psychiatric disorders) or physical causes (for example cardiac or pulmonary problems) for reduction in functioning; hypertension; unable/unsafe to participate in Functional Capacity Evaluation (FCE); contra-indication for use of prescribed medication (use of MAO inhibitors, use of SSRI*s, known liver and renal function problems, epilepsy, brain damage, COPD, pregnancy); use of opioids; not willing to stop other treatments for CLBP (physiotherapy, manual therapy etc.). Patients will also be excluded if they had previously discontinued paracetamol/tramadol therapy due to adverse effects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure: 1. To assess limitations in work related activities specific for low back pain, subtests from the Work Well Functional Capacity Evaluation (FCE) will be used: lifting low, long carry two handed, static forward bend test loaded, and dynamic bending (Table pp 7 and appendix 6). A hand grip strength test is added as a non-CLBP related performance test to control for non-CLBP related pain behaviours. 2. RMDQ: Roland Morris Disability Questionnaire (described in *measures T1*, pp 6). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Control for compliance and side effects: Three questions about compliance; one question about the dosage of the medication; open question for side effects of medication and FCE. Count remaining capsules/strips 2. Control for possible effect of mediators: VAS-score for pain, pain relief (complete, important, moderate, slight, none or worse), SCL-90-R for distress, Tampa for fear, UCL for coping-strategy and PCL for pain-cognitions, CPAQ for acceptance, hand-grip test for pain behaviors (pp 6 and 7). | — |
Countries
Netherlands
Outcome results
None listed