The objective of the proposed project is to compare the effectivity of GEXP in vivo with that of standardized physiotherapy in CRPS-I patients with pain related fear.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
pijnsyndroom
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Functional disability measured with:
1.1. Radboud Skills Questionnaire (RASQ; Oerlemans, Cup et al., 2000), for
upper limbs.
1.2. Walking Ability Questionnaire (WAQ; Perez et al., 2002), for lower
limbs.
Secondary outcome
2. Physical activity in daily life, measured with the accelerometer Actiwatch
(Cambridge Neurotechnology Ltd., Cambridge, UK) for upper and lower limbs.
3. Body function and structure:
3.1. Pain, measured with:
a) Neuropathic Pain Scale (NPS; Galer & Jensen, 1999).
b) McGill Pain Questionnaire Dutch version (MPQ-DLV; Melzack, 1975; van der
Kloot, Oostendorp, van der Meij, & van den Heuvel, 1995).
3.2. Sensory symptom allodynia, measured with Von Frey hairs (Rommel et al.,
1999).
3.3. Vasomotor symptoms: temperature differences (IR thermometry), coloured
area's scored from a digital picture.
3.4. Sudomotor symptoms: edema, measured as difference in volume.
3.5. Motor symptom flexibility (goniometry).
4. Fear of movement measured with:
4.1. Tampa Scale for Kinesiophobia (TSK; Goubert et al., 2004; Vlaeyen,
Kole-Snijders, Boeren, & van Eek, 1995).
4.2. Photograph series of daily activities (PHODA) for upper limbs (PHODA-UE;
Dubbers & Vikström, 2003) and for lower limbs (PHODA-LE; Jelinek, Germes, &
Leyckes, 2003).
5. Fear of pain measured with the Angst Pain Anxiety Symptoms Scale (PASS-20;
McCracken & Dhingra, 2002).
6. Catastrophizing, measured with the Pain Catastrophizing Scale (PCS;
Sullivan, Bishop, & Pivik, 1995).
7. Coping with pain measured with the Pijn Coping en Cognitie Lijst (PCCL;
Stomp-van den Berg et al., 2001).
8. Emotional distress: Hospital Anxiety and Depression Scale (HADS; Zigmond &
Snaith, 1983).
9. Participation, measured with the IPA (IPA; Cardol, de Haan, van den Bos, de
Jong, & de Groot, 1999).
10. Emotional involvement measured with the potential emotional involvement
subscale of the Inventarisatielijst Sociale Betrokkenheid (ISB; Van Dam Baggen
& Kraaimaat, 1992).
Background summary
Research on the treatment of CRPS-I, as described in the Dutch evidence based
treatment guidelines (Richtlijn Complex Regionaal Pijn Syndroom type I, 2006),
mainly showed improvement at the level of coping with pain. Only little
improvement in functional restoration was found. Research in other pain
populations such al neck- and back-pain patients has shown that pain related
fear contributes to the development of functional disability. GEXP in vivo
which aims on systematically reducing fear of movement, shows promising results
in CRPS-I patients (de Jong et al., 2005).
Study objective
The objective of the proposed project is to compare the effectivity of GEXP in
vivo with that of standardized physiotherapy in CRPS-I patients with pain
related fear.
Study design
The study concerns a single blinded, single center, randomized clinical trial.
The treatment will be preceded by two pre-measures. After treatment there will
be one post-measurement, 6 and 12 month follow-up measurements.
Intervention
The two interventions that will be compared are GEXP in vivo (de Jong et al.,
2005) and standardized physiotherapy according to the protocol of Oerlemans,
Oostendorp, de Boo en Goris (1999). The GEXP in vivo comprises 17 sessions of
one hour, the physiotherapy treatment of 34 sessions of 30 minutes. Both
treatments will be given over a period of 17 weeks.
Study burden and risks
The burden of the study is that patients have to fill questionnaires on five
occasions (ca. 1,5 hours per occasion) and that physiological measures will be
taken on four of these occasions (ca. 1 hour per occasion).
Furthermore, patients will be asked to complete a dairy with 15 short questions
during the intervention and during 7 days around all occasions of measurement
(ca. 5 min. per day).
In addition patients are required to wear three accelerometers for periods of 7
days on four occasions. The accelerometers are very small and light and will
not be much of a hinder.
On four occasions of each two weeks patients will be asked to keep a diary in
which they keep track of disease related expense. This will only take a couple
of minutes per week. Patients will also be asked to keep track of the number of
home exercise they completed and how much time they spent on them. This will
only take 2-3 minutes per day.
A benefit of participation in the study is that patients can be treated more
effectively in future.
Postbus 616
6200 MD Maastricht
NL
Postbus 616
6200 MD Maastricht
NL
Listed location countries
Age
Inclusion criteria
1. Diagnosis CRPS-I according to IASP criteria.
2. Pain related (PHODA-LE-score >= 35 and PHODA-UE-score >= 32)
3. Age between 18 and 65.
4. Rehabilitation treatment has been indicated.
Exclusion criteria
1. Pregnancy.
2. Insufficient fluency in Dutch.
3. Generalized pain syndrome.
4. Dystonia.
5. Psychopathology
6. Involvement in a claim regarding the disease.
7. Symptoms on both upper or both lower extremities.
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 |
|---|---|
| ClinicalTrials.gov | NCT00625976 |
| CCMO | NL20067.068.08 |