© Borgis - New Medicine 1/2013, s. 3-8
*Aneta Dąbek, Janusz Domaniecki, Piotr Czyżewski, Małgorzata Bujar-Misztal
Evaluation of selected therapeutic methods in patients with primary Raynaud”s syndrome
Department of Rehabilitation, Józef Piłsudski University of Physical Education, Warsaw, Poland
Head of Department: Małgorzata Łukowicz, MD, PhD, assoc. Prof.
Introduction. The only treatment method for individuals with primary Raynaud”s widely used in Poland, is drug therapy.
Aim. The aim of the study was to demonstrate experimentally that other non-pharmacological treatment for primary Raynaud”s sufferers are possible, and to determine their efficacy.
Material and methods. The paper describes and discusses the results of comprehensive assessment of 60 patients of the Department of Dermatology. The patients were randomly assigned to a control group and two experimental groups (relaxation therapy and physical therapy, 20 patients each). As it would be unethical to deny treatment to those patients assigned to the control group, that group received drug therapy alone, while the other two groups received drug therapy plus additional treatments (infrared sauna or relaxation training). All patients were assessed on three occasions: at baseline (before the experiment) (I), and after twelve (II) and twenty-four (III) weeks of treatment. The paper presents the results of assessment of changes in capillary circulation (by capillaroscopy), pain, sweating (VAS scale), frequency of Raynaud”s attacks (questionnaire), and level of anxiety (STAI questionnaire).
Results. The experimental groups (physical therapy and relaxation therapy) demonstrated significantly better results on capillaroscopic examination after 24 weeks of treatment compared to the control group (p = 0.015 and p = 0.030, respectively). After 24 weeks of treatment, the physical therapy group reported a lower level of pain than the control group at p = 0.032.
Conclusions. The results of the study show that the health-related problems of patients with primary Raynaud”s require an interdisciplinary approach.
The Raynaud”s syndrome is a paroxysmal vasoconstriction of peripheral arterioles in hands, more rarely feet, ears, tongue or mamma. The contraction lasts 15 to 45 minutes. During the ischemic paroxysm an intensive paleness of the fingers is observed and the patient complains of sensory disorders, also called ‘numb” fingers. After the ischemic paroxysm, redness and finger swelling is visible and the patient experiences strong pulsing pain (1-3).
The Raynaud”s disease pathomechanism has not been thoroughly explored.
Excessive mental excitation (stress) and cold are considered as the main cause of primary Raynaud”s syndrome (4).
Studies (5) shown a strong connection between Raynaud”s disease and affection of nail plates and exacerbation of mycosis. Apart from typical mycotic changes, untreated Raynaud”s disease may lead to shallow nail ruptures, whitlow and ulcerations (2).
The only treatment method for individuals with primary Raynaud”s widely used in Poland, is drug therapy. Preferred are the preparations with prolonged action as they lower the risk of side effects such as headaches, skin redness, blood pressure drop and gastro-esophageal reflux. Pharmacotherapy often doesn”t bring expected result, requires huge expenses and is inconvenient for the patient – medications need to be administered 3 to 4 times daily (4, 6).
Researchers (7-9) proved the efficacy of analgesic laser therapy in patients with primary Raynaud”s syndrome.
Foreign literature widely describes the therapy of patients with primary Raynaud”s employing the biofeedback phenomenon (10).
Few authors (4, 10, 11) claim that relaxation and acupuncture should be primal part of primary Raynaud”s syndrome treatment, especially in patients, in whom the stress is the main trigger of ischemic attacks.
The aim of the study was to demonstrate experimentally that other non-pharmacological treatment for individuals with primary Raynaud”s is possible, to determine their efficacy and to evaluate patients” subjective sentiments towards experimental forms of therapy.
Following hypothesis was assumed:
1. IR sauna has therapeutic values in rehabilitation of patients with primary Raynaud”s syndrome.
2. Relaxation constitutes the efficient form of therapy in rehabilitation of patients with primary Raynaud”s syndrome.
In order to verify the above hypothesis, the following experimental question was asked:
1. Will the therapy proposed in experimental groups lead to significant improvement of the following factors:
– capillary circulation
– hand pain reduction
– hand sweating reduction
– decrease of Raynaud”s syndrome frequency
MATERIAL AND METHODS
The study included 98 patients with Raynaud”s disease aged between 18 and 50 years-old. Patients have been undergoing an ambulatory treatment in Dermatology Clinic of Warsaw Medical University. Qualification for the study was based on the completion of the following criteria:
Age over 18 years.
– History of clinical symptoms characteristic for the primary Raynaud”s phenomenon for at least two years.
– Characteristic capillaroscopic image (blood congestion, vasospasm, Raynaud”s loops).
– Absence of concomitant disease justifying the primary Raynaud”s phenomenon.
– Drug therapy with pentoxifylline prescribed by dermatologist.
– Absence of contraindications for the use of IR sauna.
Patients with Raynaud”s disease were qualified to three following groups: control and two experimental groups with physical and relaxation therapy. The therapy lasting 24 weeks was successfully finished by 60 individuals. Table 1 shows characteristics of the study group including group abundance, age and sex.
Table 1. Study group characteristics.
|n (number of patients)||20||20||20|
|Sex (F; M)||20F||19F; 1M||20F|
|Age (years)||33 ± 13||25 ± 4||33 ± 10.5|
The study was conducted with the permission of Senate Ethical Committee for Scientific Research of Józef Piłsudski University of Physical Education in Warsaw (SKE 001/18-1/2007).
Patients with Raynaud”s disease participated in evaluation three times: at the therapy baseline (I examination), after 12 weeks of therapy (II examination) and after 24 weeks of therapy (III examination). Following parameters were evaluated: microcirculation and hand sweating, pain, anxiety level. To asses the efficacy of applied therapeutic procedures, following methods were used.
Capillaroscopic examination was carried out in order to assess changes in both hands” microcirculation (12).
Due to a high cost of this method, capillaroscopy was conducted twice – before (I examination) and after the therapy (II examination). Comparative three degree scale was applied, in which “-1” indicated deterioration, “0” – absence of changes and “1” indicated improvement.
Hand pain evaluation
Evaluation of hand pain was established with the use of Visual Analogue Scale (VAS). The VAS scale is a horizontal line, 10 cm in length, with labels anchored at each end (the minimum and the maximum), on which the patient marks the point representing the intensity of perceived pain. The result is presented in millimeters (distance between the point and the left end of the stretch) (13). Patients indicated the usually perceived pain.
Hand sweating evaluation was also conducted employing VAS scale. Patients indicated the usual hand sweating degree
Frequency of ischemic attacks
Assessment of the Raynaud”s syndrome recurrence was carried out based on one week”s period. The study participants answered the following question: “How often do you experience Raynaud”s symptoms?”
A. once a week
B. twice a week
C. three times a week
D. more frequently (how often?)
The study data were analyzed with the use of SPSS statistical package ver.14. Kolmogorov-Smirnov test was used to estimate probability distributions. Multi-factorial ANOVA was used to compare values of the parameters such as: hand pain, hand sweating, symptom”s frequency per week. The Kruskal–Wallis one-way analysis of variance was used to test the quality of capillary circulation medians among groups. The lowest range of significance level was set at p ≤ 0.05.
As it would be unethical to deny treatment to patients assigned to the control group, this group received pharmacotherapy alone, while the other two groups received pharmacotherapy and additional treatments (infrared sauna or relaxation training). All individuals taking part in the study were administered pentoxifylline, prescribed by a dermatologist, twice a day. Therapy among patients with Raynaud”s disease lasted for 24 weeks.
Experimental group – relaxation
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