The primary aim of the present study is to investigate whether the Mindset Reconditioning program can safely be applied in patients with CRPS. A secondary aim is to assess the efficacy of Mindset Reconditioning before the preparation of a randomized…
ID
Source
Brief title
Condition
- Other condition
- Musculoskeletal and connective tissue disorders NEC
Synonym
Health condition
CRPS
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety evaluation of the Mindset Reconditioning program is the primary aim of
the study, and therefore, the primary outcome measures are chosen to detect
changes at the level of severity of CRPS signs and symptoms during the phase of
Mindset Reconditioning, including measures of body functions (pain,
swelling/edema, temperature, skin color, and active range of motion),
activities, participation and personal factors, according to the domains of the
International Classification of Functioning, Disability and Health [ICF-WHO].
Secondary outcome
The selection of these outcome parameters will also provide data on the
efficacy of this approach as a secondary aim of this study.
Background summary
Complex regional pain syndrome (CRPS) can develop after a physical injury (e.g.
a fracture, sprain or surgery) and results in pain and functional disability.
The current hypothesis is that it can be safely and effectively treated by
reconditioning the patient*s mindset and autonomic nervous response.
Study objective
The primary aim of the present study is to investigate whether the Mindset
Reconditioning program can safely be applied in patients with CRPS. A secondary
aim is to assess the efficacy of Mindset Reconditioning before the preparation
of a randomized controlled trial.
Study design
Observational pilot study, proof-of-concept
Intervention
Mindset Reconditioning is a biopsychosocial approach to health and life style
combining current best practices in cognitive behavioral and physical
therapies. Its aim is operant reconditioning of the mindset and autonomic
nervous response in order to break the vicious cycle of pain, fear and
disability in CRPS.
Study burden and risks
The burden of the study consists of 6 sessions (time burden 1hour/visit) during
the treatment phase followed by 5 follow-up visits (time burden 30min/visit)
for measurements and filling out questionnaires. Patients will be advised to do
daily exercises (time burden 20 min/day) for as long as is helpful to them.
Based on empirical data we do not anticipate treatment related risks related to
participation in this study, but it is possible (though unlikely) that the
patient*s condition might worsen. The benefits strongly outweigh the risks as
patient*s condition may improve significantly within 60 days including 6
sessions. The current Dutch CBO guideline for treatment of CRPS is perceived as
disappointing with chronification, disability and subsequent high medical costs
and personal suffering. The study can only be done in adults with CRPS.
Meibergdreef 9
Amsterdam 1100DD
NL
Meibergdreef 9
Amsterdam 1100DD
NL
Listed location countries
Age
Inclusion criteria
Patients between 18 and 80 years of age with CRPS of either upper or lower extremity according to the International Association for the Study of Pain (IASP) criteria between 3 and 24 months after initial injury will be selected for the study.
Exclusion criteria
A potential subject with neurological or psychiatric disorders and/or CRPS in more than 1 extremity will be excluded from participation in this study.
Design
Recruitment
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 | NL49815.018.14 |