This study aims to investigate the effect of analgetics on a functional capacity evaluation (FCE) and self reported disability in patients with CLBP.
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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).
Background summary
Background
Disability resulting from non-specific chronic low back pain (CLBP) continues
to be a large problem in western societies. According to the bio-psycho-social
model, patient's functioning is influenced by biomedical, psychological and
social factors. One of the factors is pain. Pain may lead to sensitization of
pain modulating systems and this sensitization may lead to ongoing of the
perception of pain in the absence of actual tissue damage; the pain becomes
chronic. Chronic pain decreases functional capacity and increases disability of
patients with CLBP. In many cases analgetics are prescribed to strive for
reduction of pain and disability, improvement of functional capacity and return
to work. It is still unknown what role analgetics will have on the actual
performance and disability of the patient. The proposed study will shed light
on the effect of analgetics on reduction of disability in patients with CLBP.
Study objective
This study aims to investigate the effect of analgetics on a functional
capacity evaluation (FCE) and self reported disability in patients with CLBP.
Study design
Randomized Placebo-Controlled Clinical Trial.
Intervention
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 titrated to maximally paracetamol
1950 mg; 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.
Control for compliance and side effects will take place.
Study burden and risks
Side effects
1. Tramadol has a number of potential side effects of which the subjects will
be informed prior to enrollment. Side effects will also be tracked throughout
the study.
The potential side effects are:
- Very often (>10%): nausea, dizziness;
- Often (1-10%): constipation, vomiting, dry mouth, sweating, confusedness, and
headache;
- Sometimes (0.1-1%): dyspepsia, retching, palpitations, tachycardia,
tiredness, itching, urticaria, orthostatic
hypotension, cardiovascular deregulation.
- Rare (0.01-0.1): vision problems, psychological reactions, tremor,
paresthesies, anorexia, miction problems,
muscle weakness.
- Very rare (<0.01%): convulsions, bradycardia, allergic reactions,
anaphylaxia, liverfunction problems, and
depression of ventilation.
In a prior study however no serious adverse effects due to tramadol were
observed (Ruoff, 2003). In former studies discontinuation of the treatment due
to adverse effects was found in about 20% of the patients (Schnitzer, 2000;
Ruoff, 2003).
2. Paracetamol seldom has side effects. These concern allergic reactions. Other
adverse effects (for example liver problems) only occur in much higher doses
than used in this study, or with longer use.
3.The FCE has been proven to be safe for patients with chronic low back pain.
It can lead to a temporary increase in symptom intensity, but in a former study
symptoms always returned to pre-FCE level.
Dilgtweg 5
9751 ND, Haren
Nederland
Dilgtweg 5
9751 ND, Haren
Nederland
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-004227-39-NL |
| CCMO | NL22301.042.08 |