Study on the effect of pain medication on functional capacity and self reported disability in patients with chronic low back pain; a triple blinded RCT

Conditions: benign low back pain
chronic low back pain
10028393

Registration Number: NL-OMON32166

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 50

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measure:<br /><br><br /><br>1. To assess limitations in work related activities specific for low back pain,<br /><br>subtests from the Work Well Functional Capacity Evaluation (FCE) will be used:<br /><br>lifting low, long carry two handed, static forward bend test loaded, and<br /><br>dynamic bending (Table pp 7 and appendix 6). A hand grip strength test is added<br /><br>as a non-CLBP related performance test to control for non-CLBP related pain<br /><br>behaviours.<br /><br><br /><br>2. RMDQ: Roland Morris Disability Questionnaire (described in measures T1, pp<br /><br>6).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1.Control for compliance and side effects:<br /><br>Three questions about compliance; one question about the dosage of the<br /><br>medication; open question for side effects of medication and FCE. Count<br /><br>remaining capsules/strips<br /><br>2. Control for possible effect of mediators:<br /><br>VAS-score for pain, pain relief (complete, important, moderate, slight, none or<br /><br>worse), SCL-90-R for distress, Tampa for fear, UCL for coping-strategy and PCL<br /><br>for pain-cognitions, CPAQ for acceptance, hand-grip test for pain behaviors (pp<br /><br>6 and 7).</p><br>