Chronic Low Back Pain Clinical Trial
Official title:
An Investigation Into the Effectiveness of Treatment of Chronic Low Back Pain
RATIONALE: Exposure in vivo therapy aims to reduce pain-related fear - a key maintaining
factor of chronic low back pain- while increasing level of daily functioning, despite the
pain. This is done by exposing patients to their most feared activities/movements, while
behavioral experiments are performed that serve to correct catastrophic (erroneous) beliefs
about pain. Yet, performing exposure exercises might be very threatening for patients and
might encourage them to build in subtle safety-seeking behavior. Whether safety-seeking
behavior should be allowed or not during therapy is heavily debated. Whereas some argue that
it will only interfere with therapeutic progress because it prevents the disconfirming
experience exposure tries to offer, other argue that it will facilitate therapeutic progress
because it enhances one's sense of control, if used judiciously. So far
(clinical-)experimental studies have provided mixed evidence nor have they lead to any
clinical recommendation. Hence, in a replicated single-case experiment, we will compare
exposure therapy with versus exposure without safety-seeking behavior versus exposure only.
STUDY POPULATION: Participants are chronic low back pain patients seeking treatment, who
fulfill all inclusion and exclusion criteria and participate voluntarily.
INTERVENTION: All participants receive exposure therapy at the rehabilitation department of
the academic hospital in Maastricht, but with different recommendations for the use of
safety-seeking behavior.
We will assess: 1) daily measures of fear, pain intensity and self-reported achievement of
goals and 2) non-daily measures of pain disability, pain-related fear, pain catastrophizing,
pain solutions, need to control and safety-seeking behavior. To measure to the influence of
safety-seeking behavior on actual level of functioning, two behavioral performance tasks
will also be presented, ie. a bag carrying task and a personalized task.
BURDEN AND RISKS: There are no risks associated with participation to this study that are
not otherwise related to rehabilitation and movement in general and participation is
completely voluntary. Participants are requested to fill out questionnaires on a daily basis
at home (computerized if possible), as well as on different time points during the study and
at follow up and perform two behavioral performance tasks. This study could help to further
improve the beneficial long-term effects of exposure.
n/a
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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