A double-blind study of the efficacy of topical ketorolac tromethamine gel in the treatment of ankle sprain, in comparison to placebo and etofenamate.

In a double-blind, placebo-controlled study the efficacy and safety of topical ketorolac tromethamine were assessed in the reduction of inflammation and pain due to ankle sprain. Ketorolac 2% gel was compared with etofenamate and placebo (ketorolac vehicle) in a 15-day study. Patients attended for visits on days 1 (admission), 2, 3, 4, 8, and 15 of the study. Measurements of efficacy were ankle volume, pain measured on visual analogue scales (VAS) and verbal rating of pain. Safety was assessed by volunteered adverse events and vital signs. A total of 37 patients was admitted to the study of whom 13 received ketorolac, 12 placebo, and 12 etofenamate. One patient receiving ketorolac was lost to follow-up on day 15 owing to an unrelated accident. The remaining 36 patients completed the study. Ketorolac was significantly better than placebo in reducing the volume of the injured ankle based on the maximum, the area under the curve, and the day 15 percentage changes in ankle volume. Results for etofenamate were similar to those for ketorolac for all three variables and there were no significant differences between the active treatments. Reductions in VAS pain at rest were more marked in the ketorolac group than either of the other groups at all visits. On day 4 the differences between ketorolac and each of the other groups were statistically significant. Reductions in VAS pain on movement were also greatest for the ketorolac group at all visits. The differences between ketorolac and each of the other groups achieved statistical significance on days 4 and 8, but were marginal in terms of significance on day 2.(ABSTRACT TRUNCATED AT 250 WORDS)

[A 3-month, randomized double-blind dose-response study with 0-(beta-hydroxyethyl)-rutoside oral solutions]. / 3monatige, randomisierte doppelblinde Dosis-Wirkungsstudie mit 0-(Beta-Hydroxyäthyl)-rutosid-Trinklösungen.

The antioedematous effect of 0-(beta-Hydroxylethyl)-rutoside (HR)-drinking solutions with 600, 900, 1200 and 1500 mg active substance was tested in a randomized double-blind study against placebo with 30 female patients in the change of life. The decrease of the oedemas was measured by recording the change in the leg volume. The patients valued the symptoms "tired and heavy legs", "tenseness" and "tingling sensation". After 3 months the daily taking of HR-drinking solutions showed a significant decrease of leg volume. At the end of the treatment there was no significant difference between the four verum groups.

Benzydamine cream in post-traumatic oedema.

The therapeutical effect of drugs for ankle distortions was quantified by a volumetric method and by load distribution during walking. The results obtained were comparable and showed that 5% benzydamine cream was very effective in the reduction of oedema of post-traumatic origin.

[Cybernetic studies of the behavior of human equilibrium using frequency analysis (2)]. / Kybernetische Untersuchungen zum menschlichen Gleichgewichtsregelverhalten mittels Frequenzanalyse (Teil 2).

The present paper describes the evaluation of static and dynamic experiments investigating the regulation of human balance. The results from a neurologically unremarkable group of test subjects are reported and discussed. These results are compared with those of a patient suffering from multi-infarction disease.

[Computer-assisted analysis of pressure distribution on cattle claws]. / Computergestützte Analyse von Druckverteilungsmessungen an Rinderklauen.

A newly developed measuring device was applied to quantify in 5 first and 5 second lactation cows of the breed German Black and White the pressure distribution underneath the claws of one front limb. The pressure distribution of cows was recorded five times in intervals of four weeks. At each measuring date each had to undergo three tests. Procedures for image processing were applied in analysis of pressure distributions. The average pressure per sqcm was about 19 N, the maximum pressure measured was 59 N per sqcm in first lactating cows and 56 N per sqcm in second lactation cows. Factors were developed which characterize the patterns of pressure distributions. Especially the "gradient factor" seems to be well suited to recognize inhomogeneous pressure distributions.

[Pressure distribution on the sole of the human foot while standing and walking, barefoot and with shoes]. / Die Druckverteilung an der Fusssohle des Menschen im Stehen und Gehen, barfuss und im Schuh.

For more than a century, scientists and practicians of orthopedic shoe production have been increasing their knowledge on the normal statics and dynamics of the lower extremities as well as on innate or often acquired posture anomalies and foot deformities. Even amongst young adults, barely half of one percent has so-called "inconspicuous" feet without restrictive signs of foot deformities. Consequently, the resulting primary illnesses and secondary injuries must be treated. Quantitative pressure distribution graphs in isobaric representation at the heel barefoot when standing and walking were determined by means of an improved, locally fixed device by Elftman and Helm. For the first time, a newly developed mobile measuring process allows measuring pressures at the heel inside the shoe while standing as well as while walking, running or jumping. The rolloff motion of the heel allowed the determination of a "maximum pressure line." Orthopedic recommendations for the production of true-to-form and true-to-function shoes for walking and sports shoes are included.

[Improving seating comfort in wheelchairs for the prevention of pressure sores]. / Verbesserung des Sitzkomforts in Rollstühlen zur Vermeidung von Druckgeschwüren.

The risk factors for occurrence of pressure sores--pressure, temperature and humidity--were measured in extensive tests on commercially available wheelchair designs. The effects of different chair positions on the strain and pressure distribution on the backrest, seat surface and foot rests were recorded on a universally adjustable experimental chair. In order to appraise the influence of various types of handicaps, the experiments were conducted with paraplegic, spastic and hemiplegic subjects. It became evident from the results obtained that the currently used suspension belt chairs display serious deficiencies, inherent in their construction principle. Above all, they do not offer an adequately large support area to handicapped persons with severe atrophy of the gluteal muscle. Also, a backrest shape with lumbar pad, as requested by physiologists and orthopaedic surgeons, is technically difficult to realize. Considerable improvements with respect to pressure distribution and orthopaedically correct support of the seated patient can be achieved by using a shell seat construction. In order to enable the handicapped person to use various sitting postures, the backrest should be provided with a rotary joint to the sitting surface.

[The effect of topical treatment in the treatment of disease in ankle sprains]. / Einfluss einer topischen Behandlung auf den Krankheitsverlauf bei Sprunggelenks-Distorsionen.

The efficacy of Mobilat ointment (100 g contain: Extract. suprarenale 1.0 g, Mucopolysaccharide-polysulfate 0.2 g, salicylic acid 2.0 g) in the treatment of acute lateral distortions of the ankle was tested in a randomised, placebo-controlled, double blind study. The criteria used for the assessment of the progress of healing were the pressure distribution during walking, the swelling of the injured region and the evaluation of pain using a visual analogue scale. During the period of treatment and observation lasting 2 weeks, all the assessment criteria showed a more rapid regression in the symptoms and signs of the disorder on treatment with the active product. The differences were statistically significant for all the criteria assessed.

[Treatment of acute ankle sprains. Comparison of the efficacy and tolerance of 2 indomethacin-gel preparations]. / Behandlung akuter Sprunggelenkdistorsionen. Vergleich von Wirksamkeit und Verträglichkeit zweier Indometacin-Gel-Präparate.

In a controlled randomized double-blind study, the effectiveness and tolerance of two gels containing the active substance indomethacin used in the treatment of acute sprains of the ankle were compared. Reduction in swelling and the evaluation of pain served as the criteria for the success of treatment. Over a treatment and observation period of two weeks, the parameters decreased rapidly and equally in both groups. At no time were statistically remarkable differences observed for any of the parameters. With respect to the main target parameter, the two preparations were seen to be of equal therapeutic effectiveness. Nor were there any differences in the tolerance of the two indomethacin gels.

[Pressure distribution under the human footsole: qualitative and quantitative results (author's transl)]. / Die Druckverteilung unter der menschlichen Fusssohle: Qualitative und quantitative Messergebnisse.

Results obtained with an already described device (Beierlein 1977) are presented. 16 subjects (4 with "normal feet", 4 with pes valgus and flat-foot, 4 with splay foot and 4 with combined flat- and splay foot) were taken for the following investigations of pressure distribution under the human footsole: Standing subjects: 1. Standing on two feet, barefoot with fixed upright posture; 2. dynamic unrolling of the bare-footed human footsole with constant walking speed. Examples of coloured isobares of the pressure distribution of a "normal foot" and splay-flatfoot are presented. Further the results of a hollow foot are described. The measured pressures vary between 4.9 and 78.5 N/cm2 (= 0.5 and 8 kp/cm2). Examples of interpretations are given to stimulate orthopedic surgeons to use the created measuring technique for definition and diagnosis of foot deformities.

[Possibilities for the use of a device to measure pressure distribution in anthropometric and orthopedic assessment of foot data]. / Einsatzmöglichkeiten eines Druckverteilungsmessgerätes zur anthropometrischen und orthopädischen Fussdatenerfassung.

Based on a quantitative registered picture of the pressure-distribution under the human foot sole the evaluation of anthropometric sizes is described and compared with usual methods. A sectorial evaluation of the pressure-distribution including an analysis of weight, area, maximum pressure and average pressure in the different sectors is reported. It is discussed, how this standardizable method can support an orthopedic diagnosis using static and dynamic pictures of the pressure-distribution of the foot.

Time course of the anti-oedematous effect of O-(beta-hydroxyethyl)-rutosides in healthy volunteers.

O-(beta-hydroxyethyl)-rutosides (HR) is used for the treatment of disorders of the venous and microcirculatory systems. In order to evaluate the time course of its activity, the effect of HR on a provocation model of orthostatic oedema in healthy volunteers was used. After a 2 week placebo run-in period, 16 healthy volunteers were randomized to HR (2 tablets of 500 mg/day) of placebo for a further 3 weeks, in a double-blind parallel design. Oedema was provoked by standing motionless for 1 h, with measurement of leg volume before and afterwards. The procedure was undertaken at entry to the study and then weekly during the entire 5 week period. There were no significant differences in the extent of oedema produced by the orthostatic challenge during the 2 week run-in period or in the subjects who continued on placebo (approximately 90 arbitrary units i.e. approximately 48 ml). During the 3 week treatment with HR, however, there was a progressive reduction (-1.1, -5.9, and -7.6 arbitrary units after 1, 2, and 3 weeks, respectively) in the volume of induced oedema, which was significant after 2 and 3 weeks of treatment compared to the placebo group.

Investigation of the therapeutic equivalence of different galenical preparations of O-(beta-hydroxyethyl)-rutosides following multiple dose peroral administration.

Oxerutins (O-(beta-hydroxyethyl)-rutosides, HR, Venoruton) are available in different releasing galenical formulations for the treatment of chronic venous insufficiency (CVI). In order to investigate the biopharmaceutical relevance of the releasing properties of the galenical forms the therapeutic efficacy between the commercially available forms was investigated (500 mg sustained release film tablets, 300 mg sustained release film tablets, 300 mg normally releasing capsules) in comparison to an aqueous solution and placebo. In total 100 female patients with CVI grade II participated. The study was carried out following a randomized, placebo controlled design with parallel treatment groups. Following a two-week run-in phase patients were treated for 12 weeks with different posologies of HR (2 x 1/d 500 mg, 3 x 1/d 300 mg, 1 x 1000 mg/d as aqueous solution). Main criterion was the reduction of leg volume following 12 weeks treatment. Subjective criteria were descriptively evaluated. All four HR treatments were significantly superior to placebo (p < 0.0008). The different posologies had no influence on the efficacy. The therapeutic efficacy is independent of the in vitro rate of release. The available forms are regarded as bioequivalent.