Prolonged conservative treatment or 'early' surgery in sciatica caused by a lumbar disc herniation: rationale and design of a randomized trial [ISRCT 26872154]

BACKGROUND: The design of a randomized multicenter trial is presented on the effectiveness of a prolonged conservative treatment strategy compared with surgery in patients with persisting intense sciatica (lumbosacral radicular syndrome). METHODS/DESIGN: Patients presenting themselves to their general practitioner with disabling sciatica lasting less than twelve weeks are referred to the neurology outpatient department of one of the participating hospitals. After confirmation of the diagnosis and surgical indication MRI scanning is performed. If a distinct disc herniation is discerned which in addition covers the clinically expected site the patient is eligible for randomization. Depending on the outcome of the randomization scheme the patient will either be submitted to prolonged conservative care or surgery. Surgery will be carried out according to the guidelines and between six and twelve weeks after onset of complaints. The experimental therapy consists of a prolonged conservative treatment under supervision of the general practitioner, which may be followed by surgical intervention in case of persisting or progressive disability. The main primary outcome measure is the disease specific disability of daily functioning. Other primary outcome measures are perceived recovery and intensity of legpain. Secondary outcome measures encompass severity of complaints, quality of life, medical consumption, absenteeism, costs and preference. The main research question will be answered at 12 months after randomization. The total follow-up period covers two years. DISCUSSION: Evidence is lacking concerning the optimal treatment of lumbar disc induced sciatica. This pragmatic randomized trial, focusses on the 'timing' of intervention, and will contribute to the decision of the general practictioner and neurologist, regarding referral of patients for surgery

Cost-effectiveness of a vocational enablement protocol for employees with hearing impairment; design of a randomized controlled trial

Background: Hearing impairment at the workplace, and the resulting psychosocial problems are a major health problem with substantial costs for employees, companies, and society. Therefore, it is important to develop interventions to support hearing impaired employees. The objective of this article is to describe the design of a randomized controlled trial evaluating the (cost-) effectiveness of a Vocational Enablement Protocol (VEP) compared with usual care. Methods/Design. Participants will be selected with the 'Hearing and Distress Screener'. The study population will consist of 160 hearing impaired employees. The VEP intervention group will be compared with usual care. The VEP integrated care programme consists of a multidisciplinary assessment of auditory function, work demands, and personal characteristics. The goal of the intervention is to facilitate participation in work. The primary outcome measure of the study is 'need for recovery after work'. Secondary outcome measures are coping with hearing impairment, distress, self-efficacy, psychosocial workload, job control, general health status, sick leave, work productivity, and health care use. Outcome measures will be assessed by questionnaires at baseline, and 3, 6, 9, and 12 months after baseline. The economic evaluation will be performed from both a societal and a company perspective. A process evaluation will also be performed. Discussion. Interventions addressing occupational difficulties of hearing impaired employees are rare but highly needed. If the VEP integrated care programme proves to be (cost-) effective, the intervention can have an impact on the well-being of hearing impaired employees, and thereby, on the costs for the company as well for the society. Trial registration. Netherlands Trial Register (NTR): NTR2782. © 2012 Gussenhoven et al; BioMed Central Ltd

A quasi-randomised controlled trial of water as a quick softening agent of persistent earwax in general practice.

BACKGROUND: Earwax is a common problem in general practice. The incidence of complaints owing to earwax in general practice in the Netherlands is 39.3 per 1000 patients. AIM: To determine the feasibility of a strategy using water as a quick dispersant for persistent earwax, compared with the usual strategy using oil as a dispersant for three days in a general practice setting. DESIGN OF STUDY: Practice based, prospective controlled intervention study. SETTING: Forty-two patients (59 ears) in four general practices in the Netherlands. METHOD: Patients with persistent earwax were randomised into an intervention group and a control group. For patients in the intervention group, water drops at body temperature were dropped into the impacted ear and the auditory meatus was blocked with a wet wad of cotton. After the patient had waited for 15 minutes in the waiting room a series of attempts at syringing was completed. Patients in the control group received the usual strategy and were instructed to soften the earwax with oil each night before sleeping and to block the auditory meatus with a wad of cotton, for three days. They were asked to come back after three days for the second attempt of syringing. For both strategies the mean number of syringing attempts (and 95% confidence interval) was calculated and compared by testing the difference between the means using a t-test for independent samples. All ears in which the wax was still persistent after another five syringing attempts were given the value of 6 in the calculations. RESULTS: The mean number of syringing attempts needed per patient in the intervention group was 3.0 (95% CI = 2.4 to 3.6) and for the control group, the mean was 2.4 (95% CI = 1.7 to 3.1). The difference between means (0.6, 95% CI = 0.3 to 1.5) was not statistically significant (P = 0.18). CONCLUSION: A patient with persistent earwax can stay in the waiting room following the initial series of five attempts at syringing, with water instilled in the ear canal. After 15 minutes, the earwax is removed as easily as in the usual strategy using oil instilled for three days. The strategy using water as a dispersant for persistent earwax is quick and more convenient for the patient

The whispered voice: the best test for screening for hearing impairment in general practice?

Hearing loss is an important health problem in the elderly which sometimes leads to social isolation. In a study with 62 patients, the diagnostic value of four simple tests for screening for hearing loss in general practice was examined. When paying attention to the loudness of the whispering, the whispered voice test can be a valuable test for assessment of hearing loss in general practice

Blink reflex recovery curves in blepharospasm, torticollis spasmodica, and hemifacial spasm

R1 and R2 blink reflex responses to single and paired stimuli were investigated in 23 control subjects, 21 patients with blepharospasm (BSP), 20 patients with torticollis spasmodica (TS), and 23 with hemifacial spasm (HFS). For paired stimuli, we compared measurements of area and peak responses at two and three times R2 threshold. R1 and R2 indices were calculated as the average of the recovery values at 0.5-, 0.3-, and 0.21-s interstimulus intervals to test individual patients. Peak amplitude measurements at three times R2 threshold were optimal. The R2 index was abnormal in 67% of BSP patients, 37% of TS patients, and 50% of HFS patients on the affected side and 20% on the unaffected side. A normal R2 index in one third of patients with BSP may indicate that different pathophysiological mechanisms are involved in this type of focal dystoni