To evaluate the (cost)effectiveness of a classification algorithm, based on patient*s symptoms andclinical presentation, that directs patients with non specific LBP to the therapy (exercise therapy ormanual therapy) that they are most likely to…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
General perceived recovery (7-point scale), functional status (ODI), pain
intensity (11-point NRS),
general health (SF-36) and quality of life (EuroQol). Assessments take place at
baseline, and 8, 26 and
52 weeks after randomization.
Secondary outcome
n a
Background summary
Low back pain (LBP) is common and has major consequences. Exercise therapy and
manual therapy
are frequently applied and there is strong evidence that both are more
effective than no treatment. But
effects are modest and it is still unclear what patients benefit most from what
type of treatment.
Study objective
To evaluate the (cost)effectiveness of a classification algorithm, based on
patient*s symptoms and
clinical presentation, that directs patients with non specific LBP to the
therapy (exercise therapy or
manual therapy) that they are most likely to benefit from. In an US-based
study, this algorithm has
proven to be effective. This is compared to the usual care.
Study design
A randomized controlled trial including cost-effectiveness and cost-utility
analyses.
Intervention
Patients are randomized into the two groups. In the classification group
patients receive treatment
(exercise therapy or manual therapy) as decided by the classification
algorithm. Patients in the control
group receive usual care, that is without using the classification algorithm
for treatment decision making.
Study burden and risks
The interventions as provided in this study are part of the daily routine in
primary health care and therefore there are no risks in taking part in this
study. The only extra burden is that some extra measurements will take place
one before, and three afterwards in the course of one year. The physical
measures (e.g. range of motion) are also part of daily routine in primary
health care with no risks. The other measures include questionnaires only. This
relative small burden is in proportion to the potential value as the results of
this study can be used for improving the health care for patients with low back
pain in the future.
van der Boechorststraat 7
1081 BT Amsterdam
NL
van der Boechorststraat 7
1081 BT Amsterdam
NL
Listed location countries
Age
Inclusion criteria
patients with non-specific LBP for more than 6 weeks who attend a physiotherapist or manual therapist (with or without a GP referral). Non specific LBP is defined as pain and discomfort, localized below the costal margin and above the inferior gluteal folds, with or without leg pain
Exclusion criteria
Pain caused by specific patho-physiological disorders (e.g. hernia nuclei pulposi, fracture or tumor).
Design
Recruitment
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 |
|---|---|
| CCMO | NL20371.029.07 |
| OMON | NL-OMON23039 |