Treatment of Sympathetic Reflex
Dystrophy
(SRD) with Hyperbaric Oxygen Therapy (HBO)
Background
Sympathetic Reflex Dystrophy ("Sudeck-Atrophy", "Algodystrophy") is a commonly serious complication after trauma or operation of extremities. Incidence ranges from 1 to 35 % and does not correlate with the extends of the trauma or operative intervention (Mathes 1984, Richter & Brackertz 1989). The underlying pathogenesis of the disease is mainly unknown. The theory, already mentioned by Sudeck, of an overreaction inflammatory response is still the favourite. With this reaction micro vascular changes occur, followed by an increased permeability for large proteins, disturbed metabolism of high energy phosphates, and a reduced oxygen consumption in the affected extremity. Treatment is limited to symptomatic measures (Kozin 1985, Küntscher 1998, Matthes 1984, Ott 1974, Veldman 1993). A total restitution can only be achieved in very small minority of the patients.
Possible mechanisms of HBO Therapy in SRD are (Knighton et al. 1981, 1983, Silver 1984)
Enhancement of microcirculation,
Reduction of oedema,
Improvement of local metabolism and recalcification,
Reduction of the inflammatory response.
Purpose of the Study
To investigate in a prospective study, if the course of the disease of patients with a manifest SRD can be positively influenced by adjunctive HBO Therapy.
Selection of Patients
Inclusion criteria
Patients with a manifest SRD in Stage I will be included in the study, when they fulfil the following criteria of the Nijmegen Classification (Veldmann et al 1993):
1. 4 out of 5:
2. Start or increase of the symptoms when extremity is used
3. Manifestation of the symptoms expanding the area of the primary injury or operation and distally thereofStage I is equally to the acute („hot") phase of the first 2-3 month.
Exclusion criteria
Methods
Therapy arms
Therapy arms are differed by:
A Standard treatment (Antiphlogistics, Elevation, Physiotherapy, Plexus catheter with Guanethidin blockade)
B Standard treatment plus HBO Therapy (3 x 30 min, 2,4 bar, 20 days 1x daily.)
Randomisation
Randomisation of the patients will be achieved by telephone.
Evaluation Criteria
Examination of the patients includes:
Examinations are carried out in defined time intervals:
Time interval (weeks)
Pre-operative |
2 |
4 |
8 |
12 |
|
Swelling |
X |
X |
X |
X |
X |
Mobility |
X |
X |
X |
X |
X |
Sensibility |
X |
X |
X |
X |
X |
Power |
X |
X |
X |
X |
X |
Temperature |
X |
X |
X |
X |
X |
Colour |
X |
X |
X |
X |
X |
Pain sensation |
X |
X |
X |
X |
X |
DASH |
X |
X |
X |
||
Bone density |
(x) |
(x) |
Patient amount
In each study arm 20 patients are proposed.
Ethics
Participation in the study requires written informed consent of the patients, especially on the risks and benefits of HBO Therapy.
Statistics
The main criterion will be tested statistically, while the other criteria will be described by data analysis. Definitive estimation of the necessary amount of patients is not possible, as no data are available to estimate the possible improvement.
Study Group
Priv.-Doz. Dr. H. Menke, Dr. S. Kluge, Dr. M. Küntscher, Prof. Dr. G. Germann
Department of Burns, Plastic- and Handsurgery, BG-Unfallklinik Ludwigshafen, Clinic for Plastic- and Handsurgery of the University of Heidelberg -
Dr. Peter Müller, HBO-Zentrum Rhein-Neckar am Diakonie-Krankenhaus Mannheim Speyerer Strasse.
The
hospital in Ludwigshafen has numerous patients and excellent experience in the
treatment of SRD, therefore adequate treatment with Ergo- and Physiotherapy
etc. is also provided. The Hyperbaric Centre in Mannheim is specialised for
the treatment with hyperbaric oxygen therapy, a long experience in this field
is granted.
Literature (selected)
Study protocol NOT finalised !!!
|
Corresponding Author