Guest guest Posted December 4, 2004 Report Share Posted December 4, 2004 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: Unexplained diffuse pain Difference in skin colour compared to the opposite extremity Diffuse oedema Difference in skin temperature compared to the opposite Decreased range of movement 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 thereof Stage I is equally to the acute („hot " ) phase of the first 2-3 month. Exclusion criteria Arterial occlusive disease (pulse less) Raynaud Disease Thrombophlebitis Autoimmune or rheumatic disease Generalised osteoporosis 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: Swelling (circumference of wrist, middle hand with volumetry), Mobility (fist closure, finger stretching, hand span, wrist), Sensibility (Semmes-Weinstein), Power measurement at fist closure (computer aided in alternate grip), Pain medication consume, Subjective pain sensation by visual analogue scale, Temperature and Colour with comparison of opposite site, DASH (main criterion), Bone density measurement with identifiable decalcification in conventional radiographs. 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. 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) Field J, Monc C, Atkins RM (1993) J Hand Surg Br Jun 18 (3): 339 Knighton DR, Hunt TK, Schenestuhl H et al (1983) Science 221: 1283 Knighton DR, Silver IA, Hunt TK (1981) Surgery 90: 262 Kozin F (1985) In: McCarthy DJ (ed) „Arthritis and allied conditions " , Lea & Feabinger, Philadelphia, 1322-1355 Küntscher MV Promotionsschrift Heidelberg 1998 Mathes H (1984) Hefte zur Unfallheilkunde 164: 547 Ott VR (1974) Fortbildk Rheumatol 3: 166 Richter D, Brackertz D (1989) Z Rheumatol 48: 72 Silver IA (1984) In: Soft and Hard Tissue Repair. Hunt TK, Heppenstall RB, Pines E (Eds) New York: Praeger (1984), 50-66 Veldman PH, Reynen HM, Arntz IE, Goris RJ (1993) Lancet 342 (8878): 1012 Study protocol NOT finalised !!! Send comments or expressions of interest to: Dr. med. HJ Müller HBO-Zentrum Rhein-Neckar Diakoniekrankenhaus Mannheim Speyerer Strasse 91-93 D-68163 Mannheim/Germany Phone: +49-621-8102-390 e-mail: dr.mueller@hbo-mannheim Quote Link to comment Share on other sites More sharing options...
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