The effect of the intervention on pain an regain of function in de affected extremity. This will be quantified in multiple questionnaires at baseline and three follow-up points, and by clinical evaulation of the hand function at baseline and two…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain, measured in Visual Analoque Scale (VAS)-Score
Secondary outcome
- Function in the extremity (RASQ-questionnaire and function tests)
- Health Related Quality of Life (SF-36 questionnaire)
Background summary
CRPS type-1 is a pain syndrome that usually develops after an initiating
noxious event (e.g. fracture) in an extremity. Although treatment options life
dimethyl-sulphoxide (DMSO), N-acetylcysteine (NAC) and intensive physical
therapy exist, the treatment effect is often unsatisfactory, even leading to
amputation of the extremity. Surgical treatment of chronic pain disorders by
dividing the sympathetic chain is an established treatment. Its more invasive
nature has prevented widespread application. After introduction of minimal
invasive techniques in recent years, the UMCG has now devised a truly minimal
invasive, yet safe and effective thoracoscopic technique, that requires only a
single 1 cm long incision in the anterior axillary line. This technique is
developed as treatment for primary focal axillary and palmar hyperhidrosis, and
is performed in over 50 patients producing very satisfying results. This fact
has led to the hypothesis that this same surgical technique can offer this
group of chronic pain patients a safe, effective treatment modality.
Study objective
The effect of the intervention on pain an regain of function in de affected
extremity. This will be quantified in multiple questionnaires at baseline and
three follow-up points, and by clinical evaulation of the hand function at
baseline and two follow-up points.
Study design
Single center prospective feasibility study
Intervention
Unilateral single-port VATS sympathicotomy on T2-T5 level.
Study burden and risks
Participants will have to fill-out 2 questionnaires at baseline and at three
different points of follow- up. They will undergo pre-operative clinical
examination at the hand clinic of the rehabilitation center, routine blood and
urine testing, ECG, and pre- and postoperative chest X-ray examination. At 1
and 6 months follow-up several parameters measuring hand function will be
evaluated in a clinical setting. Risks associated with the intervention include
chylothorax and pneumothorax requiring prolonged drainage (<1%), bleeding, and
surgical wound infection (<1%). Compensatory hyperhidrosis (excessive sweating)
and referred pain have been described (<6%) after such procedures performed as
treatment for primary hyperhidrosis. It is not known if this side-effects is
seen when the operation is performed for the indication CRPS-I.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
CRPS-I refractory to standard treatment
Age 18-65 years
Exclusion criteria
COPD > Gold I
>20 packyears smoking
Previous thoracic surgery on affected side
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 | NL41466.042.12 |