A double-blind, crossover study of a sustained-release tablet of ketoprofen and normal ketoprofen capsules in the treatment of patients with osteoarthritis.

A double-blind, crossover study was carried out to assess the efficacy and tolerance of a sustained-release tablet formulation of ketoprofen given as a single daily 200 mg dose compared with 2 X 50 mg normal formulation capsules of ketoprofen twice daily. Eighty-four patients with osteoarthritis of the hip and/or knee were admitted and received treatment for periods of 3 weeks, preceded by a 1-week placebo wash-out period, with each of the two formulations, in random order. Patients were seen after each study period and clinical objective and subjective assessments made of signs and symptoms of the disease, consumption of rescue analgesic and unwanted effects. Forty-eight of the patients continued, mainly on the sustained-release formulation, in an open long-term tolerance study lasting 3 months. The results were analyzed for 68 patients who completed the double-blind phase and for 33 who completed the open phase of the study. The patients who were withdrawn did so mainly for non-drug related reasons; 19 patients did so because of gastric disorders during the first phase. The incidence of side-effects was low and similar in frequency and nature with both formulations; those that were reported were mild and principally gastro-intestinal. Both active treatment periods afforded similar symptomatic relief and were preferred to placebo by all but 2 patients. No significant differences were found between active treatments, although there was a trend in favour of the sustained-release formulation for most of the parameters studied as there was in patient preference.

Are radiologic changes in the thoracic and lumbar spine of adolescents risk factors for low back pain in adults? A 25-year prospective cohort study of 640 school children.

STUDY DESIGN: This report was based on a 25-year prospective cohort study and designed as a self-administered questionnaire with low back pain as the main topic. OBJECTIVE: To identify whether radiologic changes in the thoracic and lumbar spine and a history of low back pain in the adolescent period represent risk factors for low back pain in adults. SUMMARY OF BACKGROUND DATA: Six-hundred-forty 14-year-old school children were examined with x-rays of the thoracic and lumbar spine and registered by the school doctor regarding a history of low back pain. METHODS: All of the x-rays and the short journals from the school doctor's registration were reviewed. This primary information was the basis of the investigation 25 years later. RESULTS: Eleven percent of the cohort had a history of low back pain in adolescence, and the results showed an 84% lifetime prevalence of low back pain in these subjects as adults and an increased frequency of low back pain the last month and week before they answered the questionnaire, compared with the rest of the cohort. These problems were associated with increased morbidity and decreased working capacity. Thirteen percent had radiologic abnormalities, mainly Scheuermann changes, in the thoracic and lumbar spine as adolescents, with no positive correlation to low back pain in this period. Unlike other reports, our results did not confirm a positive correlation between x-ray changes in the lower spine in adolescents and a higher prevalence of low back pain in adults. Stepwise logistic regression analyses showed that low back pain in the growth period and familial occurrence of back disease are important risk factors for low back pain later in life, with an observed probability of 88% if both factors are present. CONCLUSION: This study suggests that low back pain in the growth period is "a real problem," with a trend toward aggravation as time passes. Thus, implementing preventive measures in schools may be very important.

[Are low back pain and radiological changes during puberty risk factors for low back pain in adult age? A 25-year prospective cohort study of 640 school children]. / Giver laendesmerter og radiologiske forandringer i puberteten risikofaktorer for senere laendesmerter? En 25 års prospektiv kohorteundersøgelse af 640 skoleelever.

Recent reports have stated that low back pain (LBP) among children is a common problem comparable with that in adults. This 25-year prospective cohort study confirms that 11% of the cohort have had a history of LBP in adolescence with an 84% lifetime prevalence of LBP in these subjects as adults compared with 70% in the rest of the cohort. LBP was associated with increased morbidity and decreased working capacity. Thirteen percent of the cohort had radiological abnormalities, mainly Scheuermann changes, in the thoracic and lumbar spine as adolescents, with no positive correlation to LBP in this period. Unlike other reports our results did not show any association between X-ray changes in the lower spine in adolescents and a higher prevalence of LBP in adults. Stepwise logistic regression analyses showed that LBP in the growth period and familial occurrence of back disease are important risk factors for LBP later in life, with an observed probability of 88% if both factors are present. Preventive measures in the school period seem to be of great importance.

[Intensive dynamic back exercises for patients with chronic low back pain. A controlled study]. / Intensiv dynamisk rygtraening til patienter med kronisk laenderygsmerte. En kontrolleret undersøgelse.

The effect of intensive dynamic back extensor exercises for patients with chronic low back was investigated in a controlled clinical trial where the patients underwent a three months intensive training program a total 30 sessions. The 105 patients were divided into three groups: a treatment group, an alternative group which underwent 1/5 of the treatment group's exercise program per session, and an alternative group in which the treatment consisted of thermotherapy, massage and mild exercise. Regardless of whether the outcome of treatment is assessed qualitatively or quantitatively, a statistically significant, favourable difference was found between the results for the treatment group and those for the alternative groups. The therapy was found to be without risk, but patients with clinical signs of current lumbar nerve root compression or radiological signs of spondylolysis or halisteresis of the column were excluded from the study. The authors recommend the introduction of this form of treatment as a general offer in the primary and secondary health sector. Back exercises can advantageously be conducted in a group; thus, the resources required for this treatment do not differ significantly from those required for many of the other forms of treatment generally employed, which often require individual attention.

Epidemiological aspects and risk factors for low back pain in 38-year-old men and women: a 25-year prospective cohort study of 640 school children.

This study is based on data gathered by means of a postal questionnaire from a cohort of 640 38-year-old subjects. At the age of 14 years these subjects had been interviewed by their school doctor to ascertain whether any of them had a history of low back pain (LBP), and X-rays of the thoracic and lumbar spine were taken. The questionnaire contained related groups of questions, with LBP as the main topic. We wanted to identify probable risk factors in developing LBP. The results show a cumulative life-time prevalence of LBP of 70%, a 1-year prevalence of 63% and a point prevalence of 19%, independent of gender. Women reported a higher incidence of LBP than men during the month and week before they filled out the questionnaire, they also reported a higher incidence of sciatica and greater use of the health care system and analgestics over the previous year. Heavy manual work was associated with LBP and sciatica, and smoking (more than 16 cigarettes per day) was more common among unemployed and sick-listed subjects, Severe LBP was associated with increased morbidity, reduced work capacity, deterioration in social life, mental and sexual problems, and increased smoking. A stepwise logistic regression analysis of "early" independent variables indicated that severe LBP is positively correlated with low social class for men and with menstruation and pregnancy for women.

Low back pain and physical exercise in leisure time in 38-year-old men and women: a 25-year prospective cohort study of 640 school children.

A cohort of 38-year-old men and women were studied for leisure time physical exercise in relation to low back pain (LBP), education, work, social class and smoking by a self-administered questionnaire. At the age of 14 years, the subjects had been interviewed by their school doctor regarding history of LBP and radiographs of the thoracic and lumbar spine were taken. The results show no positive correlation between radiographic changes and LBP in the adolescent period and decreased physical activity in adulthood. Physical activity for at least 3 h/week reduces the risk of LBP measured as lifetime, 1-year and point prevalence. Eighty-five percent of the subjects who reported taking physical exercise for at least 3 h/week had participated in sports activity almost constantly since their school days and these reported being in better condition than the rest of the cohort. Otherwise they did not have a healthier mode of life. No physical exercise during leisure time was associated with a short school education, unskilled work, unemployment and sickness, low social class, divorce, living in an apartment and smoking. Sixty percent had never or not for many years been interested in participating in sports. Badminton and tennis were the most common sports practised (36%), followed by gymnastics (32%), ball games-soccer and team handball-(25%), running (20%) and swimming (18%). Gymnastics and swimming seem to reduce LBP significantly. Our results show a falling interest in participating in sports activities over time, with 68% of the subjects being members of an athletic association previously, but only 29% currently. Women were more physically inactive during leisure time, probably because of their dual role. Logistic regression analysis indicates that physical activity is related to a long school education, high social class and regular sports activity over time.

Clinical trial of intensive muscle training for chronic low back pain.

105 patients who had chronic low back pain without clinical signs of lumbar nerve root compression or radiological evidence of spondylolysis or osteomalacia were randomised to three treatments: 30 sessions of intensive dynamic back extensor exercises over three months; a similar programme at one-fifth the exercise intensity; or one month of thermotherapy, massage, and mild exercises. The results consistently favoured intensive exercise, which had no adverse effects. Since these exercises can be conducted in groups, the intensive programme is no more costly than conventional strategies that require individual attention.