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Biomedical subjects

R Leclaire

Publications and source records attributed to R Leclaire.

At least 19 recordsLinked to original sources

Radiofrequency facet joint denervation in the treatment of low back pain: a placebo-controlled clinical trial to assess efficacy.

STUDY DESIGN: A prospective double-blind randomized controlled trial was performed. OBJECTIVE: To assess the efficacy of percutaneous radiofrequency articular facet denervation for low back pain. SUMMARY OF BACKGROUND DATA: Uncontrolled observational studies in patients with low back pain have reported some benefits from the use of facet joint radiofrequency denervation. Because the efficacy of percutaneous radiofrequency had not been clearly shown in previous studies, a randomized controlled trial was conducted to assess the efficacy of the technique for improving functional disabilities and reduce pain. METHODS: For this study, 70 patients with low back pain lasting of more than 3 months duration and a good response after intraarticular facet injections under fluoroscopy were assigned randomly to receive percutaneous radiofrequency articular facet denervation under fluoroscopic guidance or the same procedure without effective denervation (sham therapy). The primary outcomes were functional disabilities, as assessed by the Oswestry and Roland-Morris scales, and pain indicated on a visual analog scale. Secondary outcomes included spinal mobility and strength. RESULTS: At 4 weeks, the Roland-Morris score had improved by a mean of 8.4% in the neurotomy group and 2.2% in the placebo group, showing a treatment effect of 6.2% (P = 0.05). At 4 weeks, no significant treatment effect was reflected in the Oswestry score (0.6% change) or the visual analog pain score (4.2% change). At 12 weeks, neither functional disability, as assessed by the Roland-Morris scale (2.6% change) and Oswestry scale (1.9% change), nor the pain level, as assessed by the visual analog scale (-7.6% change), showed any treatment effect. CONCLUSIONS: Although radiofrequency facet joint denervation may provide some short-term improvement in functional disability among patients with chronic low back pain, the efficacy of this treatment has not been established.

Adult↗

First lifetime back pain and psychiatry treatment: psychological factors and recovery in compensated workers.

The role of psychological factors in recovery from first lifetime low back pain (LBP) was explored in this study. Consecutive clients from one physiatry clinic in Montreal who had LBP of less than 3 months' duration, were on sick leave and receiving workers' compensation benefits, and reported the current event as first lifetime LBP were enrolled. Psychological factors that fluctuate with current events (Psychiatric Symptom Index) and remain stable over time (General Well Being Scale) were assessed. Outcomes were late return to work (> 31 days) and 1 year incidence of compensated recurrence. Results from two multivariate models indicated lower psychological distress predicted late return to work, and higher well being, higher aggressiveness, and lower anxiety predicted compensated recurrence. Researchers concluded psychological factors do not impact clients with all types of LBP in the same way. For individuals lacking prior LBP experience, better psychological functioning increased lengthy work absence. Thus, awareness of the clients' psychological profiles and previous LBP experiences may benefit recovery.

Adult↗

Epidural corticosteroid injections for sciatica due to herniated nucleus pulposus.

BACKGROUND: Although epidural corticosteroid injections are commonly used for sciatica, their efficacy has not been established. METHODS: In a randomized, double-blind trial, we administered up to three epidural injections of methylprednisolone acetate (80 mg in 8 ml of isotonic saline) or isotonic saline (1 ml) to 158 patients with sciatica due to a herniated nucleus pulposus. All patients had Oswestry disability scores higher than 20 (on a scale of 1 to 100, with scores of 20 or less indicating minimal disability, and higher scores greater disability). RESULTS: At three weeks, the Oswestry score had improved by a mean of -8.0 in the methylprednisolone group and -5.5 in the placebo group (95 percent confidence interval for the difference, -7.1 to 2.2). Differences in improvements between the groups were not significant, except for improvements in the finger-to-floor distance (P=0.006) and sensory deficits (P=0.03), which were greater in the methylprednisolone group. After six weeks, the only significant difference was the improvement in leg pain, which was greater in the methylprednisolone group (P=0.03). After three months, there were no significant differences between the groups. The Oswestry score had improved by a mean of -17.3 in the methylprednisolone group and -15.4 in the placebo group (95 percent confidence interval for the difference, -9.3 to 5.4). At 12 months, the cumulative probability of back surgery was 25.8 percent in the methylprednisolone group and 24.8 percent in the placebo group (P=0.90). CONCLUSIONS: Although epidural injections of methylprednisolone may afford short-term improvement in leg pain and sensory deficits in patients with sciatica due to a herniated nucleus pulposus, this treatment offers no significant functional benefit, nor does it reduce the need for surgery.

Adult↗

A cross-sectional study comparing the Oswestry and Roland-Morris Functional Disability scales in two populations of patients with low back pain of different levels of severity.

STUDY DESIGN: This cross-sectional study compares the Oswestry and Roland-Morris disability scales in two groups of patients with low back pain of different clinical and electromyographic severity. OBJECTIVES: To evaluate the correlation between functional disability and diagnoses. SUMMARY OF BACKGROUND DATA: There is an increasing need for functional disability measurements to be applied to the evaluation of therapy and outcome in patients experiencing low back pain. METHODS: Two very different groups of patients with low back pain completed the Oswestry and Roland-Morris self-administrated functional disability questionnaires. One group included patients presenting with an episode of mechanical low back pain with no clinical radiculopathy. The other group consisted of patients with low back pain and clinical and electromyographic evidence of radiculopathy. RESULTS: Patients diagnosed with low back pain who exhibited signs of radiculopathy on electromyography had a mean score of 49.1 +/- 17.1 on the Oswestry disability questionnaire; a mean score of 33.0 +/- 14.7 was found for patients who experienced "simple" low back sprain (with no radiculopathy). This difference was statistically significant (P < 0.0001). On the Roland-Morris questionnaire, the mean score obtained by the group of patients with radiculopathy was 59.1 +/- 21.8 compared with 45.4 +/- 19.4 for those with no radiculopathy. This difference was also statistically significant (P < 0.0001). Moreover, there exists a moderate correlation between both functional scales within each group of patients: 0.72 (P < 0.0001) in the group with radiculopathy and 0.66 (P < 0.0001) among those without radiculopathy. CONCLUSIONS: The authors conclude that both functional disability scales accurately discriminated between these two groups of patients with low back pain of very different clinical and electromyographic severity.

Adult↗

Diagnostic accuracy of technologies used in low back pain assessment. Thermography, triaxial dynamometry, spinoscopy, and clinical examination.

STUDY DESIGN: A prospective blind study compared three new technologies to assess back pain. OBJECTIVE: To assess the diagnostic accuracy and comparability of thermography, triaxial dynamometry, and spinoscopy in the assessment of recent onset work-related low back pain. SUMMARY OF BACKGROUND DATA: The role of these technologies in assessing patients with low back pain is unproved. METHODS: Forty-one patients with low back pain and 46 control subjects were assessed by each technology and by two clinical examiners blind to clinical status. Twenty patients were trained to simulate a healthy back without low back pain, and 50% of the control subjects were trained to simulate the presence of a low back pain disorder. Each technology was interpreted on two occasions by each of two readers. RESULTS: Thermography performed significantly worse than did triaxial dynamometry, spinoscopy, and clinical examination. The diagnostic accuracy of the last three was similar, and inter-rater comparability did not differ significantly. Among simulators, the diagnostic accuracy of triaxial dynamometry and spinoscopy was significantly higher than that of clinical examination, although considerable inaccuracy remained in assessing individual subjects. CONCLUSIONS: The diagnostic accuracy of thermography in recent onset low back pain does not support its use. Among those simulating normality or low back pain, triaxial dynamometry and spinoscopy have greater diagnostic accuracy than does a single clinical evaluation. However, for an individual, the inaccuracy that remains limits the use of triaxial dynamometry or spinoscopy for diagnosis in recent onset low back pain.

Adult↗

Back school in a first episode of compensated acute low back pain: a clinical trial to assess efficacy and prevent relapse.

OBJECTIVE: To assess the efficacy of a back school program for patients with a first episode of acute work-related low back pain requiring compensation. DESIGN: A randomized single-blind controlled trial. SETTING: A private physiatrics outpatient clinic. PATIENTS: The mean duration of low back pain was 15 days. INTERVENTION: Eligible patients were randomized to a standard treatment program that included daily physiotherapy (n = 86) or the same program with the addition of back school (n = 82). The back school program consisted of three 90-minute sessions given by a single trained instructor at 0, 1, and 8 weeks. MAIN OUTCOME MEASURES: The primary outcomes were the time off work for the presenting episode of back pain and the number and duration of recurrences in the year following the study onset. Secondary outcomes included the level of pain, spinal mobility, active straight-leg raising, and functional disability assessed by the Oswestry and Roland-Morris scales. RESULTS: Those randomized to the back school group gained significantly more knowledge, based on the multiple choice examination (p = .0001) and performed the exercise program significantly better (p = .0001) than the standard care group. There were no differences between the two treatment groups for either of the primary outcomes. The median time to return to work from randomization was 33 days for both the back school and the standard care groups (p = .48). The number of compensated recurrences of low back pain over 1 year was similar (back school = 14, standard care = 10, p = .16), as was the median duration of these episodes (back school = 25 days, standard care = 70 days, p = .21). There were no significant differences favoring the back school group for any of the secondary outcomes at the posttreatment, 6-month, or 12-month assessments. CONCLUSION: A back school intervention in addition to standard care resulted in no reduction in the time to return to work or the number or duration of recurrences of low back pain requiring compensation over a period of one year.

Absenteeism↗

Electromagnetic treatment of shoulder periarthritis: a randomized controlled trial of the efficiency and tolerance of magnetotherapy.

The potential benefit of magnetotherapy was investigated in 47 consecutive outpatients with periarthritis of the shoulder. Using a controlled triple-blind study design, one group of patients received hot pack applications and passive manual stretching and pulley exercises; the other group received the same therapy plus magnetotherapy. Treatment was administered three times a week. For a maximum of three months, a standardized treatment protocol was used. There was no significant improvement in pain reduction or in range of motion with electromagnetic field therapy. After 12 weeks of therapy, the patients who received magnetotherapy showed mean pain scores of 1.5 (+/- .61 SD) at rest, 2.2 (+/- .76 SD) on movement, and 1.9 (+/- .94 SD), on lying, compared to scores for the control group of 1.4 (+/- .65 SD), 2.2 (+/- .7 SD), and 1.9 (+/- .95 SD), respectively. Linear pain scale scores improved from 71 to 21 for both groups. At 12 weeks the gain in range of motion was mean 109 degrees +/- 46.8 in patients receiving electromagnetic field therapy, compared to 122 degrees +/- 33.4 for the controls (not significant). At entry, the functional handicap score was 53.5 for both groups. At 12 weeks, it was 24 for the magnetotherapy group and 17 for the control group (difference not significant). In conclusion, this study showed no benefit from magnetotherapy in the pain score, range of motion, or improvement of functional status in patients with periarthritis of the shoulder.

Aged↗

Single-dose pharmacokinetic study of 13-cis-retinoic acid in man.

A pharmacokinetic study of 13-cis-retinoic acid was performed in nine patients following administration of a single oral dose of 80 mg. An average lag time of 1.2 hours was observed, followed by fast absorption, with a mean half-life of 0.5 hour. Peak plasmatic concentration of 733 ng/ml occurred at 2.3 hours. The disposition profile showed a rapid distribution half-life of 1.3 hours and a terminal elimination half-life of 24.7 hours. No 13-cis-retinoic acid was detected unchanged in urine. An important interpatient variability was noted.

Administration, Oral↗

Pharmacokinetics of Lonidamine after oral administration in cancer patients.

The pharmacokinetics of Lonidamine has been studied in cancer patients after single and chronic oral administrations. After single administration the plasma kinetics are highly variable, while the dose eliminated in the urine is over 70% in all subjects. This suggests an active but interindividually variable first-pass effect. After repeated administrations, both the residual plasma concentration before administration (C infinity min) and that obtained after drug intake (C infinity max) have been studied. The C infinity max values range from 4.5 to 25 micrograms/ml and C infinity min values from 0.4 to 7 micrograms/ml. In patients where a therapeutic response was noted, a mean value of 2.98 micrograms/ml for C infinity min was measured. In patients unresponsive to drug therapy the mean C infinity min was 1.5 micrograms/ml.

Absorption↗

Phase I toxicologic study of Lonidamine in cancer patients.

15 patients with metastatic cancer were treated with Lonidamine, a substituted indazole carboxylic acid active against the Lewis lung and Sarcoma 180 tumors. Single doses of 600 mg (350-400 mg/m2) mostly induced somnolence and gastro-intestinal side effects. Toxicity occurring during chronic administration of Lonidamine at doses ranging between 45 and 275 mg/m2 twice daily, mainly consisted of somnolence, myalgias, hyperesthesia and mild hair loss. Myalgias and hyperesthesias were markedly relieved with prednisone 5 mg twice daily. No laboratory abnormalities were seen. In 1 patient with breast cancer resistant to standard chemotherapeutic agents, a 30% reduction of measurable tumor masses was seen. In view of the lack of overlapping toxicity between Lonidamine and other chemotherapeutic drugs, and of its potential activity, it is suggested that phase II studies of Lonidamine be initiated at a dose of 135 mg/m2 twice daily.

Adult↗

Phase II study of Lonidamine in cancer patients.

12 patients with metastatic cancer were treated with the substituted indazole carboxylic acid Lonidamine at oral daily doses of 270 mg/m2. Toxicity, consisting mainly of myalgias, somnolence, hyperesthesia, anorexia and vomiting, generally decreased or disappeared over time despite continuing drug administration at unmodified dosage. Myalgias and hyperesthesias were markedly relieved with prednisone 5 mg twice daily. No laboratory abnormalities were seen. Partial responses were observed in a patient with hypernephroma and in a patient with breast cancer. Disease-oriented phase II studies with this new anticancer agent are warranted.

Adult↗

Phase I study of 13-cis-retinoic acid toxicity.

A phase I study of 13-cis-retinoic acid was done in 16 patients with head and neck malignancies using a modified Fibonacci search scheme, with individual doses ranging from 20 to 120 mg/m2. Drug doses greater than 60 mg/m2 induced intense headaches, urethritis, desquamative dermatitis, vertigo, and ataxia. The severity of these side effects precludes the use of 13-cis-retinoic acid as a potential chemopreventive agent at doses greater than 60 mg/m2.

Adult↗