To design and test a personalized biopsychosocial rehabilitation treatment that aims to restore daily life functioning and QoL in persons with SCI and chronic pain.
ID
Source
Brief title
Condition
- Other condition
- Spinal cord and nerve root disorders
Synonym
Health condition
Chronische pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Disability: Pain Disability Index (PDI). This 7-item questionnaire investigates
the magnitude of self-reported disability in different domains, e.g., work,
leisure time, activities of daily living (ADL) and sports.
Quality of Live: The EuroQoL EQ-5D is a brief self-reported generic measure of
current health that consists of five dimensions (mobility, self-care, usual
activities, pain/discomfort, and anxiety/depression).
Secondary outcome
SCI-related complications (SCI-SCS)
Anxiety and Depression (HADS)
Pain-related fear (PASS-20)
Pain Interference (MPI-SCI)
Acceptance (AAQ-II-P)
Psychological inflexibility (PIPS)
Self-efficacy (UW-SES 6)
Background summary
Spinal cord injury (SCI) is a highly debilitating condition, accompanied by
serious secondary health conditions. Over 65% of persons with SCI also suffers
from chronic pain, resulting in additional disability and health care costs.
There is no cure for the pain. Due to heterogeneity of SCI, an integrated
approach aimed on both individual SCI-related health conditions (biomedical)
and coping with chronic pain is needed (psychological). Personalized
biopsychosocial rehabilitation programs that help to cope with these problems
are needed.
Study objective
To design and test a personalized biopsychosocial rehabilitation treatment that
aims to restore daily life functioning and QoL in persons with SCI and chronic
pain.
Study design
Single case experimental design (SCED).
Intervention
Every patient will receive a personalized biopsychosocial rehabilitation
treatment containing education and a set of sessions improving physical
functioning based on cognitive behavioural approach. All participants start
with an educational session. In addition, a personalized treatment based on a
cognitive behavioural approach will follow including one or more of the
following elements (depending on a patient*s profile): 1. Exposure in vivo (to
challenge catastrophic (mis)interpretations); 2. Acceptance and commitment
therapy (to increase the psychosocial flexibility, and to accept events, but
not to change the events); 3. Graded activity (aims to gradually increase the
amount of activity with the operant conditioning principle). Total length of
treatment for all participants will be 10-12 weeks (with two sessions each
week).
Study burden and risks
The acceptance and commitment therapy, exposure in vivo and graded activity
therapy will be delivered as add-on to the usual care for persons with SCI. The
experience of the research group with several kinds of CBT and pain education
as applied in other patient groups ensures no negative impact of the
application of this therapy in this group.
Zandbergsweg 111
Hoensbroek 6432CC
NL
Zandbergsweg 111
Hoensbroek 6432CC
NL
Listed location countries
Age
Inclusion criteria
Patients with Spinal Cord Injury (SCI) longer than 6 months; Patients with the
age of 18 years and older; Patients who suffer from SCI related chronic pain,
as classified by the International Spinal Cord Injury Pain (ISCIP)
classification; Patients where there is a willingness to address and change
biopsychosocial factors that are related to daily life functioning despite the
pain
Exclusion criteria
Patients who experience severe pain due to other diseases (e.g., neuropathies,
cancer, vascular problems)
Patients who have received a biopsychosocial rehabilitation treatment or any
other form of cognitive behavioural therapy within the past 6 months will be
excluded from this study.
Patients who have insufficient comprehension of Dutch language
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 |
|---|---|
| CCMO | NL84636.015.23 |