Efficacy of self-management program associated with a spa therapy for knee osteoarthritis patients (GETT 2): a research protocol for a randomized trial.

INTRODUCTION: Osteoarthritis is a chronic pathology that involves multidisciplinary management. Self-management for patients is an essential element, present in all international guidelines. During the time of the spa therapy, the patient is receptive to take the advantage of self-management workshops. The aim of this study is to assess the effects of 18 days spa therapy associated with a self-management intervention in patients with knee osteoarthritis in comparison with spa therapy alone on a priority objective, personalized and determined with the patient, chosen in the list of 5 objectives determined during the self-management initial assessment. METHODS AND ANALYSIS: Two hundred fifty participants with knee osteoarthritis will participate to this multicenter, prospective, randomized, controlled study. All patients will benefit 18 days of spa therapy and patients randomized in the intervention group will participate to 6 self-management workshops. Randomization will be centralized. The allocation ratio will be 1:1. Data analysts and assessor will be blinded. The primary outcome is the effectiveness of the educational workshops associated with spa therapy in comparison with spa therapy alone on a priority objective, measured by Goal Attainment Scaling (GAS). The secondary outcomes are disability, health-related quality of life, and pain intensity. ETHICS AND DISSEMINATION: Ethics were approved by the CPP Sud-Méditerranée II. The results will be disseminated in a peer-reviewed journal and disseminated at PRM, rheumatology, and orthopedics conferences. The results will also be disseminated to patients. TRIAL REGISTRATION: Trial registration number NCT03550547. Registered 8 June 2018. Date and version identifier of the protocol. Version N°6 of March 12, 2018.

Crenobalneotherapy (spa therapy) in patients with knee and generalized osteoarthritis: a post-hoc subgroup analysis of a large multicentre randomized trial.

OBJECTIVE: To determine whether the addition of spa therapy to home exercises provides any benefit over exercises and the usual treatment alone in the management of generalised osteoarthritis associated with knee osteoarthritis. METHODS: This study was a post-hoc subgroup analysis of our randomised multicentre trial (www.clinicaltrial.gov: NCT00348777). Participants who met the inclusion criteria of generalized osteoarthritis (Kellgren, American College of Rheumatology, or Dougados criteria) were extracted from the original randomised controlled trial. They had been randomised using Zelen randomisation. The treatment group received 18days of spa treatment in addition to a home exercise programme. Main outcome was number of patients achieving minimal clinically important improvement at six months (MCII) (≥-19.9mm on the VAS pain scale and/or ≥-9.1 points in a WOMAC function subscale), and no knee surgery. Secondary outcomes included the "patient acceptable symptom state" (PASS) defined as VAS pain ≤32.3mm and/or WOMAC function subscale ≤31 points. RESULTS: From the original 462 participants, 214 patients could be categorized as having generalised osteoarthritis. At sixth month, 182 (88 in control and 94 in SA group) patients, were analysed for the main criteria. MCII was observed more often in the spa group (n=52/94 vs. 38/88, P=0.010). There was no difference for the PASS (n=19/88 vs. 26/94, P=0.343). CONCLUSIONS: This study indicates that spa therapy with home exercises may be superior to home exercise alone in the management of patients with GOA associated with knee OA.

Long term improved quality of life by a 2-week group physical and educational intervention shortly after breast cancer chemotherapy completion. Results of the 'Programme of Accompanying women after breast Cancer treatment completion in Thermal resorts' (PACThe) randomised clinical trial of 251 patients.

BACKGROUND: Quality of life (QoL) after breast cancer is nowadays a major challenge. Complementary interventions are necessary because of frequent depression symptoms after treatment and also to favour return to activity. Besides, radio-chemotherapy has side-effects like weight gain and fatigue. Several strategies including group behavioural-educational interventions, physical training and/or dietary education, have been tested to answer these difficulties with moderate success in the long run. METHODS: Two hundred and fifty-one non-metastatic patients were accrued after chemotherapy in a prospective randomised multicenter trial between 2008 and 2010, testing a 2-week intervention in SPA centres. Intervention comprised group physical training, dietary education and physiotherapy. Selected patients were in complete remission. QoL was evaluated with SF36 questionnaire, anxiety and depression with the hospital anxiety and depression (HAD) one. Anthropometric measures and QoL evaluations were obtained before randomisation and every 6 months during 3 years. RESULTS: Two hundred and twenty patients were evaluable at 1 year. Intervention increased SF36 score by 9.5 points (p=0.000006), 4.6 (p=0.032) and 6.2 (p=0.028) respectively at 6, 12 and 24 months. Effect size (ES) was 0.63 [0.37; 0.90], 0.29 [0.03; 0.55] and 0.41 [0.04; 0.78]. Anxiety score was shortly minored by intervention (6-month ES=-0.24 [-0.42; -0.05]) and depression score more durably: ES=-0.45 [-0.72; -0.18], -0.34 [-061; -0.08], and -0.26 [-0.63; 0.11] at 6, 12 and 24 months. CONCLUSION: This 2-week group intervention seemed to durably influence QoL of breast cancer patients treated by chemotherapy. Differences, smaller at 12 months than at six, suggest that a second but shorter intervention could help maintain the 6-month benefits.

Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial.

OBJECTIVE: To determine whether spa therapy, plus home exercises and usual medical treatment provides any benefit over exercises and usual treatment, in the management of knee osteoarthritis. METHODS: Large multicentre randomised prospective clinical trial of patients with knee osteoarthritis according to the American College of Rheumatology criteria, attending French spa resorts as outpatients between June 2006 and April 2007. Zelen randomisation was used so patients were ignorant of the other group and spa personnel were not told which patients were participating. The main endpoint criteria were patient self-assessed. All patients continued usual treatments and performed daily standardised home exercises. The spa therapy group also received 18 days of spa therapy (massages, showers, mud and pool sessions). MAIN ENDPOINT: The number of patients achieving minimal clinically important improvement (MCII) at 6 months, defined as > or =19.9 mm on the visual analogue pain scale and/or > or =9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score and no knee surgery. RESULTS: The intention to treat analysis included 187 controls and 195 spa therapy patients. At 6 months, 99/195 (50.8%) spa group patients had MCII and 68/187 (36.4%) controls (chi(2)=8.05; df=1; p=0.005). However, no improvement in quality of life (Short Form 36) or patient acceptable symptom state was observed at 6 months. CONCLUSION: For patients with knee osteoarthritis a 3-week course of spa therapy together with home exercises and usual pharmacological treatments offers benefit after 6 months compared with exercises and usual treatment alone, and is well tolerated.

Balneotherapy, prevention of cognitive decline and care the Alzheimer patient and his family: outcome of a multidisciplinary workgroup.

According to the latest forecasts of the INSEE - Institut National de la Statistique et des Etudes Economiques (National Statistics and Economic Studies Institute), ageing of the French population will increase between 2005 and 2050: whereas 20.8% of the population living in continental France reached the age of 60 years or more in 2005, this proportion would be of 30.6% in 2035 and 31.9% in 2050. In 2050, 22.3 million persons will have reached the age of 60 years or more compared to 12.6 million in 2005, increasing by 80% in a 45-year period. In line with the actual age pyramid, ageing is unavoidable, as those who will reach 60 years of age in 2050 are already born (in 1989 or before). This expansion will be most important between 2006 and 2035, when the numerous "baby-boom" generations born between 1946 and 1975, will reach these ages. In future years, lifespan improvement will only emphasize this increase. Even if life expectancy stabilizes at the 2005 level, the number of seniors reaching 60 years or more would still increase to 50% between 2005 and 2050. This issue is identical in all countries of the European Union. Ageing is a major risk factor for dementia that will considerably worsen in the next years, if no curative therapies are found. Today, 25 million persons in the world suffer from Alzheimer's disease (AD). In France, it is estimated that 860,000 persons are affected and that 225,000 news cases are annually diagnosed. After 75 years of age, more than 20% of women and 13% of men are concerned. Forecasts for the coming years are frightening. Considering ageing of the population, the number of Alzheimer's disease cases should raise to 1.3 million in 2020 (20 patients for 1000 inhabitants) ant 2.1 million in 2040 (30 patients for 1000 inhabitants).

Modulation of the transmission in group II heteronymous pathways by tizanidine in spastic hemiplegic patients.

OBJECTIVE: To investigate the effect of tizanidine (an alpha(2) noradrenergic agonist) on transmission in the interneuronal pathway coactivated by group I and group II afferents in post-stroke patients with spastic hemiplegia. METHODS: Early and late facilitation of the quadriceps H reflex elicited in the common peroneal nerve--attributed to non-monosynaptic group I and group II excitation, respectively--was investigated in 14 spastic hemiplegic patients. All received a single dose of tizanidine (150 microg/kg) or placebo in randomised order at 10 day intervals. Repeated measurements were made at baseline (T0), 45-90 min, and 120 min after drug intake. Spasticity was assessed by modified Ashworth score in the quadriceps muscle and by a leg tone score calculated by the sum of the modified Ashworth score in five muscle groups. RESULTS: On the spastic side a decrease in late group II and, to a lesser extent, early group I common peroneal nerve induced quadriceps H reflex facilitation occurred with tizanidine (group II, mean (SEM) difference T0-T90: 34.3 (10.2)%, p<0.001; group I, T0-T120: 19.8 (9)%, p<0.05), but not with placebo (group II, difference T0-T90: 12.5 (8)%, NS; group I, T0-T120: 3.2 (7)%, NS). Tizanidine but not placebo decreased the quadriceps muscle and global lower limb Ashworth scores (2.9 (0.2) to 1.9 (0.3), p<0.001; and 12 (0.7) to 9.5 (0.8), p<0.0001, respectively). CONCLUSIONS: Enhancement of group II-group I facilitation of the quadriceps motor neurones on the spastic side of hemiplegic patients is modulated by alpha(2) noradrenergic agonists. This strengthens the view that late facilitation of quadriceps motor neurones is mediated by group II afferents and suggests that group II pathways may be involved in lower limb spasticity.

[Analgesic physical therapy. Present clinical data]. / Agents physiques antalgiques. Données cliniques actuelles.

Analgesic electrotherapy is now based on more consistent scientific data; the biological action of the electric current, of the electromagnetic radiations and of the mechanical vibrations is better approached. But the randomized control trials still provide contradictory results concerning the analgesic efficiency of the cryotherapy, the TENS, the pulsed electro-magnetic fields, the ultrasound and laser therapy, the shock waves; iontophoresis, short waves, microwaves, infrasound vibrations are very few investigated. The analgesic electrotherapy cannot be recommended nor prohibited; physical agents represent only therapeutic options. On the basis of the scientific data and of their personal experience, the therapists can use them. More controlled clinical investigations of higher methodological levels are still required.

[Feasability of a back school assessment programme]. / Etude de faisabilité dun programme dévaluation de lécole du dos.

OBJECTIVES: Testing the feasability of a back school assessment programme in two populations of people suffering with chronic low back pain. MATERIAL: Twenty-nine patients were randomly included in a chronic low back pain assessment programme (15 patients waiting for back school and 14 patients after back school). METHODS: The programme was made of the measure of the age, the sex, the body mass index, the pain (VAS, St Antoine Hospitals Pain Questionnaire - SAPQ), the anxiety, the depression, the RIII nociceptive reflex, the fingertip-floor distance, the strength of the flexors and of the extensors of the lumbar spine (CybexR 6000 isocinetic dynamometer), the lumbar function (EIFEL, Dougados), the Dallas self-questionnaire. The Back School Education programme was made of five sessions (information, ergonomics, extension exercises). RESULTS: Comparing the two populations we did not observe significant differences concerning the age, the body mass index, the anxiety and depression levels, the pain (VAS, SAPA, RIII nociceptive reflex), the lumbar stiffness, the lumbar disability, the quality of life; the patients who had achieved back school had a peak torque of the flexors and a ratio flexors/extensors significantly lower. Comparing men and women we observed significant differences in the SAPQ and the muscles strength. The SAPQ was correlated with the depression and anxiety levels, the lumbar disability, the peak torque of the flexors. The VAS was correlated with the age, the lumbar stiffness, the depression level, the peak torque of the flexors. The RIII nociceptive reflex was correlated with the ratio flexors/extensors. CONCLUSION: This study present some biases but this objective assessment of chronic low back pain appeared as feasible. The pain must be investigated in term of intensity, expression, alleviation. The impairment of the flexors muscles in women and after back school has to be confirmed. The different tests are relevant to determinate the efficiency of the back school programmes.

Facilitation of transmission in heteronymous group II pathways in spastic hemiplegic patients.

OBJECTIVE: A potent heteronymous group II excitation of quadriceps motor neurons has been recently demonstrated in normal subjects. The present study was undertaken to investigate whether this heteronymous group II excitation also contributes to spasticity in hemiplegic patients. METHOD: The early and late facilitations of the quadriceps H reflex elicited by a conditioning volley to the common peroneal nerve at three times motor threshold, attributed to non-monosynaptic group I and group II excitations respectively, were investigated. The comparison was drawn between results obtained in 20 patients after stroke, with hemiplegia due to a vascular lesion in the territory of the middle cerebral artery, and 20 age and sex matched normal subjects. RESULTS: A significant increase in the group I as well as in the group II common peroneal nerve induced facilitation of the quadriceps H reflex was seen on the spastic side of the patients (group I: 159 (SEM 10)% of control H reflex; group II: 165 (SEM 8)%) compared with their unaffected side (group I: 126 (SEM 4)%; group II: 128 (SEM 5)%) (Wilcoxon signed rank test, p<0. 01), or to the right (group I: 132 (SEM 4)%; group II: 131 (SEM 5)%) or left (group I: 130 (SEM 3)%; group II: 135 (SEM 6)%) side of controls (Mann-Whitney U test, p<0.01). No significant correlation (Spearman rank test) was found between the degree of group I and group II induced facilitations on the spastic side of the patients and the degree of clinically assessed spasticity (Ashworth scale). CONCLUSION: These results reflect a facilitation of the transmission in the interneuronal pathway coactivated by group I and group II afferents, probably resulting from a change in their descending control in spastic hemiplegic patients.

Impairment and recovery of left motor function in patients with right hemiplegia.

OBJECTIVE: To assess the motor function of the left, supposedly unaffected, limbs of patients with an acute right vascular hemiplegia. METHODS: Fifteen patients with an acute vascular right hemiplegia and 16 matched healthy controls were studied. Motor function of the left limbs of each patient was evaluated on days 20 and 90 after their stroke using four validated tools (hand dynamometer, isokinetic dynamometer, finger tapping, and nine hole peg test). RESULTS: There was a significant impairment of motor function of the left limbs of patients at day 20 compared with controls. The impairment had recovered almost completely at day 90 after the stroke. CONCLUSION: These results show the bilateral cerebral representation of the human motor system and suggest the participation of ipsilateral motor pathways in recovery after a stroke.

Isokinetic strength testing for evaluating the efficacy of intravenous immune globulin therapy for inclusion body myositis.

Inclusion body myositis is a disease of striated skeletal muscle of unclear etiopathogenesis. Its diagnosis is difficult. Corticosteroids and immunosuppressants are of limited efficacy. Positive responses to intravenous immune globulins have recently been reported in a few patients. We used a CYBEX 6000 isokinetic dynamometer to evaluate the efficacy of intravenous immune globulin therapy in a patient with inclusion body myositis. Measurements were done at the flexors and extensors of the knee, at baseline and four and eight months after treatment initiation. A course of intravenous immune globulins (2 g per course) was given every month for five months then every two months. Isokinetic muscle strength measured at an angular speed of 180 degrees/second increased by more than 41% at both knees. As compared with muscle imaging studies (computed tomography, X-ray absorptiometry, ultrasonography, magnetic resonance imaging), isokinetic strength testing has the advantage of providing data on functional improvements under treatment.

Utility of caudal view in pelvic bone imaging.

Bone imaging of the lower pelvis often is impaired by the radioactivity of the bladder. The caudal view produces an image that clearly distinguishes the bladder from the bones. Thus, it is helpful in patients with bony lesions of the lower and anterior pelvis. The caudal view examination is completed by a backward tilting of the camera head that clarifies this distinction.

[Critical study of techniques for the detection of "light" rheumatoid factors (author's transl)]. / Facteurs rhumatoïdes "légers". Etude critique des techniques de détection.

In a number of cases of true rheumatoid arthritis, it is not possible to demonstrate the presence of 19 S "heavy" rheumatoid factors by the Waaler-Rose and globulin latex techniques. However, in some of them, 7 S rheumatoid factors are suspected. Three techniques for the detection of these "light" rheumatoid factors are described and critically evaluated. The authors report their own experience of the immuno-absorption and indirect immunofluorescence technique performed on 156 sera from RA patients. Immuno-absorption is not felt to be a reliable technique on several grounds. Indirect immunofluorescence is of value only in the diagnosis of seronegative rheumatoid arthritis where it provides information in addition to that offered by classical techniques. It is positive in 53.3% of seronegative rheumatoid arthritis sera.

[Biorheologic study of pathological synovial fluids]. / Etude biorhéologique de liquides synoviaux pathologiques.

Rheometric studies of 34 synovial fluids done using a rheometer with a cone and stage (Shirley-Ferranti type) showed that arthrotic synovial fluids had pseudoplastic characteristics (non-Newtonian) but in inflammatory rheumatisms, the characteristics index rises, the consistency decreases and the fluid tends to loose its pseudoplastic properties and to become Newtonian. Radioisotope synoviorthosis seems capable of restoring to a certain extent and in certain cases the rheometric characteristics of the pseudoplastic properties.