Primary Objective:What is the effectiveness of immediate opioid pain medication (followed by step-down) versus step-up pain medication within the treatment according general practitioners* clinical guideline in patients with (sub)acute sciatica,…
ID
Source
Brief title
Condition
- Joint disorders
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes are severity of leg pain.
Outcomes will be measured at baseline and at 3,6,9,12 weeks and 1 and 2 years
follow-up.
Secondary outcome
Secundary outcomes are adverse reactions, costs, quality of life, patients*
perceived recovery, Patients* perceived comfort during tapering of the
medication, disability, severity of low back pain, number of days with a
severity of leg pain score of 7 or more, compliance to treatment, use of
*rescue medication*, patients* satisfactionand co-interventions.
Outcomes will be measured at baseline and at 3,6,9,12 weeks and 1 and 2 years
follow-up.
Background summary
Sciatica is the most prevalent specific cause of low back disorders seen by
general practitioners. The treatment of patients with sciatica is for a large
part aimed to stay active and return to daily activities. In order to
facilitate this aim, but also as a purpose on its own pain relieve due to
adequate analgesic(s) prescription is an important condition. There are two
prescription strategies to relieve pain: A) immediate opioid pain medication,
followed by a step-down approach, and B) step-up which means first paracetamol,
if necessary than a NSAID and hereafter an opioid.
There are no data available about the (cost)-effectiveness regarding the
recommended stepped medication care in patients with sciatica.
Return to work is the most dominating factor within the total costs in
sciatica. The (cost)effectiveness of the step-down versus step-up medication
will depend on the magnitude to patients* health gain, the proportion of
patients returning to work and the time-period needed for returning to work.
Our study will assess the (cost)-effectiveness of the prescription strategy of
direct opioid prescription (step-down) as seen in daily practice compared with
pain medication by the general practitioner as described in the clinical NHG
guideline (step-up).
Study objective
Primary Objective:
What is the effectiveness of immediate opioid pain medication (followed by
step-down) versus step-up pain medication within the treatment according
general practitioners* clinical guideline in patients with (sub)acute sciatica,
over a period of 6 weeks?
Secondary Objective(s):
1) What is the cost-effectiveness of immediate opioid pain medication (followed
by step-down) versus step-up pain medication within the treatment according
general practitioners* clinical guideline in patients with (sub)acute sciatica,
over a period of 12 weeks?
2) What is the course and medical consumption (including surgery) during 2
years follow-up?
3) What are effectmodifiers for effectiveness in the two prescription
strategies for pain relieve?
Study design
A pragmatic randomized controlled trial with parallel group design, in general
practice with a 2 year follow-up period.
Intervention
Patients will be randomized in two groups: A) receiving directly morphine;
followed by a taper period (step-down, and B) receiving stepped-up medication
(Step1: paracetamol, Step2: NSAID, Step 3: tramadol, Step 4: morphine).
Study burden and risks
The burden will be minimal because the trial evaluates medications that are
already prescribed frequently in patients with sciatica. Besides that, the
allocated medication strategies are prescribed conform the Dutch clinical
guidelines of the general practitioners. A rather small burden for the patients
is that they have to fill in 7 questionnaires in a period of 2 years, and
assess their daily pain and compliance to prescribed medication in a diary
during the first 3 months.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
1) Women and men aged 18 to 65 years,
2) No use of analgesics besides paracetamol,
3) Radiating (pain) complaints in one leg below the knee,
4) Severity of pain scored 7 or more on an 11-point numerical rating scale (0<= no pain; 10<= maximum pain),
5) Duration of the (pain) complaints less than 12 weeks,
6) Presence of at least one of the following symptoms: a) More pain on coughing, sneezing or straining, b) Decreased muscle strength in the leg, c) Sensory deficits in the leg, d) Decreased reflex activity in the leg, e) Positive straight leg raising test
Exclusion criteria
1) An episode of radiating (pain) complaints in the preceding 6 months,
2) Back surgery in the past 3 years,
3) Treated with epidural injections,
4) Pregnancy,
5) Co-morbidity that primary determines overall wellbeing such as an osteoporostic fracture, malignity, herpes zoster and Lymes* disease,
6) Hypersensitivity to paracetamol, NSAID or opioids,
7) Previous or active peptic ulcer,
8) Direct indication for surgery (fast progression of paresis or cauda equina syndrome),
9) History of substance addiction or abuse.
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
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-002177-11-NL |
| CCMO | NL49507.078.14 |
| Other | NTR |
| OMON | NL-OMON26984 |