In this trial we will study if treatment with oral corticosteroids or DMSO is effective in decreasing signs and symptoms of CRPS-1. Tolerance of the treatment options and effects on different subtypes of CRPS-1 patients will be evaluated as well.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
pijn patiënten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
As primary outcome the ISS score will be evaluated, which is a compound score
consisting of seperate scores based on signs and symptoms that are of
importance for patients with CRPS-1. The score goes from 5 till 50 and a
clinical relevant result is obtained when the ISS decreases 5 points from
baseline or compared to the other treatment group.
Secondary outcome
- Safety of treatment with high dose corticosteroids and tolerance of both
therapies is assessed by questionnaires and clinical evaluation.
- Reduction of inflammatory markers in urine and blood plasma compared to
baseline and between groups.
- Reduction of sensory, autonomic and motor disturbances as measured by the
McGill Pain Questionnaire, Pain Box scores, Range of motion, volumetric and
temperature assessments compared to baseline and the DMSO group compared to the
corticosteroid group.
- Increase of functional status of the affected extremity as measured by the
Walking Ability Questionnaire for lower extremity CRPS-1, and Radboud Skills
Questionnaire for upper extremity CRPS-1 compared to the baseline and between
the groups.
- Improvement of health related quality of life as measured by the SF-36 to the
baseline and between the groups.
Background summary
Complex regional pain syndrome type 1 (CRPS-1) is a painful and disabling
condition which can develop after trauma, such as a wrist fracture, distortion
or operation, but can also develops without preceding incident. CRPS-1 is
characterized by pain and sensory abnormalities, oedema and sudomotor
dysfunction, colour change, limited range of motion and autonomic disturbances
(for example, excessive sweating of the affected limb). For the Netherlands an
estimated incidence rate for CRPS-1 is 26.2 per 100.000 person years. The
progression of the disease is variable, and may lead, despite of treatments to
permanent disability.
Although various possible pathophysiological mechanisms have been described in
literature, thus far, no single mechanism can be pinpointed to explain the
complexity of symptoms exhibited in CRPS-1. However, inflammatory processes can
explain a majority of signs and symptoms in CRPS-1.
Treatment of CRPS-1, therefore, focuses on inhibition of these inflammatory
processes, using the free radical scavenger DMSO in the Dutch clinical
situation or treatment with corticosteroids in the Netherlands as well as in
other countries. However, these therapies are based on low levels of scientific
evidence. Furthermore, tolerance is not well described for both treatment
options and CRPS-1.
Study objective
In this trial we will study if treatment with oral corticosteroids or DMSO is
effective in decreasing signs and symptoms of CRPS-1. Tolerance of the
treatment options and effects on different subtypes of CRPS-1 patients will be
evaluated as well.
Study design
The study is designed as a prospective, randomised, parallel (double dummy),
double blind design.
Intervention
Patients will be treated with DMSO cream 5 times a day, combined with placebo
oral medication during a period of 26 days (tapering period included) or with
prednisolone 60 mg/day during 2 weeks, where after tapered, combined with
placebo cream 5 times a day.
Study burden and risks
The burden on the patients exists mainly of time it will consume. Patients are
asked to visit the hospital 5 times for the measurements decribed above.
Furthermore, they will fill out questionnaires four times, each time
approximately one hour time and they will keep a pain diary for 5 weeks which
will take them 5 to 15 minutes a day.
The risk of this trial consists of side effects known by the use of
corticosteroids. Rare, but severe side effects are femur and humerus head
necrosis, neurological disturbances and trombo-embolic events.
Postbus 7057
1007 MB Amsterdam
NL
Postbus 7057
1007 MB Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Patients with CRPS according to the clinical Budapest criteria
Exclusion criteria
Another (2nd) chronic pain syndrome, interfering with pain ratings; another syndrome interfering with functional tests; CRPS-1 in both hands or feet; known severe kidney insufficiency, severe liver disease; active infection; established severe osteoporosis; gastric ulcera, hypersensitivity or allergy to prednisolone, use of anti-coagulantia, medication, myasthenia gravis, previous use of DMSO for a period longer than 1 month.
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 |
|---|---|
| EudraCT | EUCTR2010-019891-54-NL |
| CCMO | NL31129.029.10 |