Based on the identified gaps in the evidence underlying the clinical guidelines on non-specific low back pain of the Dutch College of GPs and the recent findings of the Australian PACE study the objectives of the present study are: 1. What is the…
ID
Source
Brief title
Condition
- Other condition
- Joint disorders
Synonym
Health condition
pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be pain intensity (11-points numerical rating scale).
This will be captured in a (digital) daily pain and medication use diary that
particpants will complete over a 4 week follow up period
Secondary outcome
Secondary outcomes:
1. Disability measured at baseline and after 2, 4 and 12 weeks of follow up
using the Roland Morris Disability Questionnaire (score range 0-24; higher
score means more disability);
2. Patients* perceived recovery measured after 2, 4 and 12 weeks of follow-up
using a 7-point Likert scale; scores will be dichotomized into recovered or not
recovered;
3. Quality of life measured at baseline and after 4 and 12 weeks of follow-up
using the EQ-5D-5L;
4. Costs; all direct medical and patient costs measured after 4 and 12 weeks of
follow-up using the iMedical Consumption Questionnaire (iMCQ), and productivity
costs measured with iProductivity Cost Questionnaire (iPCQ);
5. Time to recovery will be assessed using the daily pain diary. Recovery is
defined as the first day of 0 or 1 pain intensity, maintained for 7 consecutive
days;
6. Compliance to treatment measured daily using a digital diary. The question
that will be used is derived from the Brief Medication Questionnaire;
7. Adverse reactions, systematically recorded in the questionnaires after 2, 4
and 12 weeks of follow-up;
8. Patient satisfaction measured after 2, 4 and 12 weeks of follow-up using an
11-point numerical rating scale; higher score means more satisfaction;
9. Sleep quality measured at baseline and after 2, 4 and 12 weeks of follow-up
using a 4 point Likert scale derived from the Pittsburgh Sleep Quality Index
(PSQI); scores will be dichotomized into good sleep quality and poor sleep
quality;
10. Co-interventions will systematically be recorded in the questionnaires
after 2, 4 and 12 weeks of follow-up.
All secondary outcomes will be recorded using digital questionnaires.
Background summary
Low back pain is a common diagnosis that is associated with a considerable
burden to patients and society. The clinical guideline on non-specific low back
pain of the Dutch College of GPs advises paracetamol as first option and NSAIDs
as second option for prescribing analgesics for patients with acute
non-specific low back pain. In 2014, the first randomized placebo-controlled
trial (RCT) of paracetamol for acute non-specific low back pain was published
(PACE study). They showed that paracetamol was not more effective than placebo
in patients with acute low back pain.
Study objective
Based on the identified gaps in the evidence underlying the clinical guidelines
on non-specific low back pain of the Dutch College of GPs and the recent
findings of the Australian PACE study the objectives of the present study are:
1. What is the effectiveness of paracetamol versus placebo regarding pain
intensity over 4 weeks in patients with acute low back pain in general practice?
2. What is the effectiveness of diclofenac versus placebo regarding pain
intensity over 4 weeks in patients with acute low back pain in general practice?
3. What is the effectiveness of paracetamol versus diclofenac regarding pain
intensity over 4 weeks in patients with acute low back pain in general
practice?
Study design
Patients who fulfill the in- and exclusion criteria and who either visit their
GP or call the doctor's assistant on the phone because of acute low back pain,
will be informed about the trial by the GP or by the doctor's assistant,
respectively. If patients are interested in participation in the trial (and in
the case of recruitment over the phone by a doctor's assistant, if a GP has
given consent for participation of this patient), the patient's contact details
will be sent to the research institute. Written information and informed
consent form will be given or sent to the patients. Patients will be contacted
within 24 hours by a researcher. Eligibility will be checked, there will be
room for questions and consequently, the written informed-consent forms will be
signed by the patient and send to the research institute both digitally (using
either e-mail or fax) and through the mail. After receiving the digital signed
informed consent form, the digital baseline assessment will be completed by the
patient. Patients will consequently be randomized, using a randomization
schedule, based on a random number generator and prepared by an independent
datamanager not involved in the study. The GP and pharmacist of the patient
will be informed about the participation of the patient in the PACE Plus trial.
Blinded trial medication will be allocated, prepared and numbered by an
independent pharmacy, not involved in the recruitment or follow-up of the
patients. Medication will be sent to the patient in the mail. Patients may use
prescribed and/or over-the-counter pain medication as usual until the study
medication arrives.
Intervention
Study treatments:
Group 1: Paracetamol 4dd1000 mg + placebo diclofenac 2dd
Group 2: Diclofenac 2dd75 mg + placebo paracetamol 4dd
Group 3: Placebo paracetamol 4dd + placebo diclofenac 2dd
Since the dosage schemes of NSAID and paracetamol differ we will make use of
double dummies (i.e. placebo paracetamol and placebo diclofenac) in order to
optimally blind patients, physicians and outcome assessment.
Study burden and risks
The burden for the patients will be minimal because the trial will evaluate
medications that are already prescribed frequently in patients with low back
pain. Besides that, the allocated medication will be prescribed conform the
clinical guidelines of the Dutch College of GPs. A rather small burden for the
patients is that they have to fill in 4 digital questionnaires in a period of 3
months, and assess their daily pain and compliance to prescribed medication
(when applicable) in a digital diary during 4 weeks. Patients allocated to
medication may experience side effects from these medicaments.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
- Mentally competent patients (male and female) presenting in general practice with acute non-specific low back pain;
- Between 18 and 60 years old;
- Experiencing a new episode of low back pain, preceded by a period of at least one month without low back pain;
- Duration of pain less than 6 weeks (in accordance with the Cochrane Collaboration Back Review Group definition for 'acute' pain;
- Primary complaint of pain in the area between the 12th rib and buttock crease, with or without leg pain;
- Low back pain severe enough to cause at least moderate pain (* 4 on 0-10 Numerical Rating Scale (NRS);
- Signed consent form.
Exclusion criteria
- Known or suspected serious spinal pathology (e.g. metastatic, inflammatory or infective diseases of the spine, cauda equina syndrome, spinal fracture);
- Currently taking recommended regular doses of analgesics conforming with the study protocol (e.g. paracetamol 4dd1000mg, diclofenac 2dd75mg or 3dd50mg);
- Spinal surgery within the preceding 6 months;
- Serious co-morbidities such as rheumatoid arthritis, heart failure, diabetes, renal insufficiency, gastric ulcers, gastro-intestinal pathology, allergy for paracetamol and/or NSAIDs or other indications preventing prescription of paracetamol and/or NSAIDs; use of proton pump inhibitors before inclusion is not an exclusion criterium, as the patient is considered to be protected (patient will have to continue using this medication during use of study medication);
- Use of coumarin derivatives, clopidogrel, prasugrel, ticagrelor, acetylsalicylic acid derivatives, systemic glucocorticosteroids, SSRIs, venlafaxine, duloxetine, trazodone, spironolactone or other medication that may interact with paracetamol and/or diclofenac;
- Known intolerance for paracetamol and/or diclofenac;
- Patients who are pregnant or planning to become pregnant during the treatment period.
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 | EUCTR2015-003882-26-NL |
| CCMO | NL54941.078.16 |