The main objective is that a cognitive behavioral intervention for patients with SFN will have a positive effect on disability and quality of life.
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Disability, and health related QOL.
Secondary outcome
The secondary endpoints are pain intensity, mood and pain catastrophizing.
Background summary
Small fiber neuropathy (SFN) is a condition that is dominated by invalidating
neuropathic pain. Pharmacological neuropathic pain treatment is often
disappointing, since pain reduction is mostly slight and side effects can be
debilitating. Although neuropathic pain is caused by a lesion of the
somatosensory system, also psychological factors, such as fear and
catastrophizing, appear to play a role in the origin and maintenance of
disability in chronic pain. Rehabilitation based on pain education and
cognitive behavioral treatment including elements of acceptance and commitment
therapy, exposure in vivo or graded activity can be performed to influence
these factors. To date no specific rehabilitation programs are available for
patients diagnosed with SFN.
Study objective
The main objective is that a cognitive behavioral intervention for patients
with SFN will have a positive effect on disability and quality of life.
Study design
Sequential replicated randomized single-case experimental ABCD-design
Intervention
Every patient will receive a personalized treatment containing education and a
set of sessions improving physical functioning based on a cognitive behavioral
approach. All participants start with an educational session. In addition, a
personalized treatment based on a cognitive behavioral approach will follow
including one or more of the following elements (depending on a patient*s
profile):
1. Exposure in vivo (to change 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). The total length of treatment for all participants will be 8-10
weeks (with two sessions each week)
Study burden and risks
All participants will receive one of the rehabilitation treatments. It is
expected that the risks associated with participation in the study are
negligible and that the burden will be minimal. The measurements that will be
conducted during the study consist of diaries and questionnaires and are not
invasive or risky full.
SFN is a chronic neuropathic pain condition, with autonomic dysfunction.
Adverse events are rarely seen in patients with small fiber neuropathy. Pain
will not be recorded as AE. It is known that patients will experience more pain
from practical experience since they are stimulated to increase their activity
level during therapy and will be actively engaged with their pain. This
temporary increase in pain is not harmful
P.Debyelaan 25
Maastricht 6229 HX
NL
P.Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- Age >18 years,
- Main goal/purpose to achieve with rehabilitation therapy,
- Skin-biopsy proven idiopathic SFN, diagnosed at our expertise center at the
department of neurology of MUMC+.
Exclusion criteria
- Are not able to provide written informed consent,
- Have an underlying condition of SFN (diabetes, SFN9A/10A/11A mutation,
hypothyroidism, renal failure, vitamin B12 deficiency, monoclonal gammopathy of
undetermined significance, alcohol abuses, malignancies, chemotherapeutic
drugs).
- Have other neurological disease than SFN that may cause pain in the feet
and/or damage to the somatosensory nervous system, are excluded.
- have received any form of cognitive behavioral therapy within the last 6
months will be excluded from this study.
- Have insufficient comprehension of Dutch language.
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 | NL82372.068.22 |